BUCCAL DOSAGE FORMS COMPRISING OLIGOSACCHARIDES

FORMES DE DOSAGE BUCCAL COMPRENANT DES OLIGOSIDES

English Abstract

The present application relates to buccal dosage forms comprising one or more cannabinoids and/or cannabinoid extracts and one or more oligosaccharides such as fructo- oligosaccharide alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin. The present application also related to buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer. The buccal dosage forms include hard molded lozenges, soft chew lozenges, and compressed tablets. The one or more cannabinoids and/or cannabinoid extracts include cannabidiol (CBD) and tetrahydrocannabinol (THC). The present application also relates to buccal dosage forms which are free from added sugars, sweeteners and/or sweetening agents. Methods of preparing the buccal dosage forms are also included.

French Abstract

La présente demande concerne des formes galéniques buccales comprenant un ou plusieurs cannabinoïdes et/ou extraits de cannabinoïdes et un ou plusieurs oligosaccharides tels quun fructo-oligosaccharide seul ou en association avec un ou plusieurs polysaccharides tels que linuline, et comprenant éventuellement un plastifiant tel que la glycérine. La présente demande concerne également des formes galéniques buccales comprenant un ou plusieurs polysaccharides tels que linuline et un plastifiant. Les formes galéniques buccales incluent les pastilles moulées dures, les pastilles à mâcher molles et les comprimés compressés. Le ou les cannabinoïdes et/ou extraits de cannabinoïdes incluent le cannabidiol (CBD) et le tétrahydrocannabinol (THC). La présente demande concerne également des formes galéniques buccales qui sont sans sucre ajouté, édulcorants et/ou agents édulcorants. Des procédés de préparation des formes galéniques buccales sont également compris.

Claims

Claims
1. A buccal dosage form comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less,
wherein the buccal dosage form is a lozenge, and the lozenge is a hard molded
lozenge, a soft
chew lozenge or a compressed tablet lozenge.
2. The buccal dosage form of claim 1, wherein the buccal dosage form is a hard
molded
lozenge.
3. The buccal dosage form of claim 2, wherein the hard molded lozenge is free
of added sugars,
sweeteners, and/or sweetening agents.
4. The buccal dosage form of claim 3, wherein the sugars are selected from
monosaccharides
and disaccharides and combinations thereof.
5. The buccal dosage form of claim 4, wherein the sweeteners are selected from
aspartame,
acesulfame potassium, advantame, erythritol, saccharin, hydrogenated starch
hydrolysates,
isomalt, lactitol, maltitol, maltitol syrup, mannitol, monk fruit extract,
neotame, sorbitol, sorbitol
syrup, stevia, steviosides, steviol glycosides from Stevia rebaudiana Bertoni,
steviol glycosides
from Saccharomyces cerevisiae CD15380, steviol glycosides from Saccharomyces
cerevisiae
CD15407, sucralose, thaumatin, xylitol, and combinations thereof.
6. The buccal dosage form of claim 5, wherein the sweetening agent is selected
from table
sugar, liquid sugar, invert sugar, liquid invert sugar, icing sugar, brown
sugar, yellow sugar,
golden sugar, refined sugar syrup, refiners' syrup, golden syrup, fancy
molasses, table
molasses, refiners' molasses, blackstrap molasses, cooking molasses, dextrose
anhydrous,
dextrose monohydrate, glucose, glucose syrup, glucose solids, dhed glucose
syrup, syrup,
lactose, honey and combinations thereof.
7. The buccal dosage form of any one of claims 1 to 6, wherein the hard molded
lozenge
comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or about
0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or the
cannabinoid extract.
8. The buccal dosage form of any one of claims 1 to 7, wherein the hard molded
lozenge
comprises the cannabis extract and the cannabis extract is a dry sift,
isolated trichomes, kief,
hash, butane, hash oil, shatter, budder, honeycomb, crumble, sap, RSO (Rick
Simpson Oil),
rosin, resin and combinations thereof.
9. The buccal dosage form of any one of claims 1 to 6, wherein the buccal
dosage form
comprises a cannabis extract and the cannabis extract is a cannabinoid
distillate.
10. The buccal dosage form of any one of claims 1 to 7, wherein the hard
molded lozenge
comprises the one or more cannabinoids selected from cannabichromene (CBC),
130
Date Recue/Date Received 2023-06-13

cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA),
cannabidivarin
(CBDV), cannabidivarinic acid (CBDVA), cannabigerol (CBG), cannabigerol acid
(CBGA),
cannabigerol propyl variant (CBGV), cannabicyclol (CBL), canna binol (CBN),
cannabinol propyl
variant (CBNV), cannabitriol (CBT), cannabichromenic acid (CBCA),
cannabidiphorol (CBDP),
cannabidiphorolic acid (CBDPA), tetrahydrocannabinol (THC),
tetrahydrocannabinolic acid
(THCA), tetrahydrocannabipgorolic acid (TPCPA), tetrahydrocannabivarin
(THCV),
tetrahydrocannabiphorol (THCP), tetrahydrocannabivarinic acid (THCVA), and
combinations
thereof.
11. The buccal dosage form of claim 10, wherein the one or more cannabinoids
are selected
from THC, CBD and combinations thereof.
12. The buccal dosage form of claim 11, wherein the buccal dosage form
comprises about 0.1
mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg,
about 0.1 mg
to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg,
about 0.1 mg to
about 2 mg, or about 0.1 mg to about 1 mg of THC.
13. The buccal dosage form of claim 12, wherein the buccal dosage form
comprises about
10mg, about 5mg, about 2.5 mg, or about 0.1mg of THC.
14. The buccal dosage form of claim 13, wherein the buccal dosage form
comprises about
10mg of THC.
15. The buccal dosage form of claim 11, wherein the buccal dosage form
comprises about 0.1
mg to about 500 mg, about 0.1mg to about 400 mg, about 0.1 mg to about 300 mg,
about 0.1
mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg,
about 0.1
mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg,
about 0.1 mg
to about 5 mg, about 0.1 mg to about 2.5 mg, or 0.1 mg to about 1 mg of CBD.
16. The buccal dosage form of any one of claims 1 to 15, wherein the hard
molded lozenge
further optionally comprises one or more emulsifying agents, one or more oils
and/or fats and/or
one or more flavourants.
17. The buccal dosage form of claim 16, wherein the one or more emulsifying
agents are
selected from monoglycerides of fatty ester, diglycerides of fatty esters,
sucrose esters of fatty
acids, polyglycerol esters of fatty acids, acetylated tartaric acid esters of
monoglycerides,
acetylated tartaric acid esters of diglycerides, citric acid esters of
monoglycerides, citric acid
esters of diglycerides, lactylated monoglycerides, lactylated diglycerides,
lactylic esters of fatty
acids, polyglycerol esters of fatty acids, polyglycerol esters of
interesterified castor oil fatty
acids, polyoxyethylene fatty esters, propylene glycol alginates, propylene
glycol ether of
methylcellulose, propylene glycol mono fatty acid esters, quillaia extract,
sodium stearoyl-2-
lactylate, sodium stearate, stearyl monoglyceridyl citrate, D-a-tocopherol
polyethylene glycol
1000 succinate, polyglycerol polyricinoleate (PGPR), polyoxy (40) hydrogenated
castor oil,
ethoxylated castor oil, polyoxy hydrogenated castor oils, polyglycolyzed
glycerides, acetylated
131
Date Recue/Date Received 2023-06-13

monoglycerides, sorbitan fatty acid esters, poloxamers, polyoxyethylene
sorbitan fatty acid
esters, polyoxyethylene derivatives, monoglycerides or ethoxylated derivatives
thereof,
diglycerides or polyoxyethylene derivatives thereof, sodium docusate, sodium
laurylsulfate,
cholic acid or derivatives thereof, lecithin, hydroxylated lecithin,
hydrolyzed lecithin, gum Arabic,
modified gum Arabic, phospholipids, hydrocolloids and combinations thereof.
18. The buccal dosage form of claim 17, wherein the one or more emulsifying
agents are
selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated
lecithin, and hydrolyzed
lecithin.
19. The buccal dosage form of claim 16, wherein the one or more oils are
vegetable oils.
20. The buccal dosage form of claim 16, wherein the one or more flavourants
are selected from
synthetic flavor oils, flavoring aromatics, natural oils, extracts from
plants, leaves, flowers, fruits
and combinations thereof.
21. The buccal dosage form of any one of claims 16 to 20, wherein the hard
molded lozenge
optionally comprises about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to
about 2% (w/w),
about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or
about 0.1% (w/w)
to about 4% (w/w) of the one or more emulsifying agents.
22. The buccal dosage form of any one of claims 16 to 21, wherein the hard
molded lozenge
optionally comprises about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to
about 2% (w/w),
about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or
about 0.1% (w/w)
to about 5% (w/w) of the one or more oils and/or fats.
23. The buccal dosage form of any one of claims 16 to 22, wherein the hard
molded lozenge
optionally comprises about 0.1% (w/w) to about 1.5% (w/w) or about 0.1% (w/w)
to about 2%
(w/w) of the one or more fiavourants.
24. The buccal dosage form of any one of claims 1 to 23, wherein the hard
molded lozenge
comprises about 10% (w/w) to about 99.9% (w/w), about 15% (w/w) to about 99.9%
(w/w),
about 20% (w/w) to about 99.9% (w/w), about 25% (w/w) to about 99.9% (w/w),
about 30%
(w/w) to about 99.9% (w/w), about 35% (w/w) to about 99.9% (w/w), about 40%
(w/w) to about
99.9% (w/w), about 45% (w/w) to about 99.9% (w/w), about 50% (w/w) to about
99.9% (w/w),
about 55% (w/w) to about 99.9% (w/w), about 60% (w/w) to about 99.9% (w/w),
about 65%
(w/w) to about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75%
(w/w) to about
99.9% (w/w), about 80% (w/w) to about 99.9% (w/w), about 85% (w/w) to about
99.9% (w/w),
about 90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w),
about 96%
(w/w) to about 99.9% (w/w), about 97% (w/w) to about 99.9% (w/w), about 98%
(w/w) to about
99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about
99.9% (w/w),
about 99.7% (w/w) to about 99.9% (w/w), about 99.8% (w/w) to about 99.9%
(w/w), about 95%
(w/w) to about 99% (w/w), about 96% (w/w) to about 99% (w/w), about 97% (w/w)
to about 99%
132
Date Recue/Date Received 2023-06-13

(w/w), about 98% (w/w) to about 99% (w/w), about 98% (w/w) to about 98.5%
(w/w), or about
96% (w/w) to about 98.5% (w/w) of the one or more oligosaccharides.
25. The buccal dosage form of any one of claims 1 to 24, wherein the hard
molded lozenge
comprises about 70% (w/w) to about 99.9% (w/w) of the one or more
oligosaccharides.
26. The buccal dosage form of claim 25, wherein the hard molded lozenge
comprises
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 70% (w/w) to about 99.9% (w/w) of the one or more oligosaccharides
having
a degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 2% (w/w) of the one or more
emulsifying
agents; and
(d) optionally about 0.1% (w/w) to about 2% (w/w) of the one or more oils
and/or fats.
27. The buccal dosage form of any one of claims 1 to 26, wherein the hard
molded lozenge
comprises about 95% (w/w) to about 99.9% (w/w) of the one or more
oligosaccharides.
28. The buccal dosage form of any one of claims 1 to 27, wherein the hard
molded lozenge
comprises
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 95% (w/w) to about 99.9% (w/w) of the one or more oligosaccharides
having
a degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 2% (w/w) of the one or more
emulsifying
agents; and
(d) optionally about 0.1% (w/w) to about 2% (w/w) of the one or more oils
and/or fats.
29. The buccal dosage form of any one of claims 1 to 23, wherein the hard
molded lozenge
further comprises one or more polysaccharides having a degree of
polymerization of up to 80
and having an average degree of polymerization of about 9 or greater.
30. The buccal dosage form of claim 29, wherein the added % (w/w) of the one
or more
polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides
in the hard
molded lozenge.
31. The buccal dosage form of claim 29 or claim 30, wherein the hard molded
lozenge
comprises about 10% (w/w) to about 99.8% (w/w), about 15% (w/w) to about 99.8%
(w/w),
about 20% (w/w) to about 99.8% (w/w), about 25% (w/w) to about 99.8% (w/w),
about 30%
(w/w) to about 99.8% (w/w), about 35% (w/w) to about 99.8% (w/w), about 40%
(w/w) to about
99.8% (w/w), about 45% (w/w) to about 99.8% (w/w), about 50% (w/w) to about
99.8% (w/w),
133
Date Recue/Date Received 2023-06-13

about 55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8% (w/w),
about 65%
(w/w) to about 99.8% (w/w), about 70% (w/w) to about 99.8% (w/w), about 75%
(w/w) to about
99.8% (w/w), about 80% (w/w) to about 99.8% (w/w), about 85% (w/w) to about
99.8% (w/w),
about 90% (w/w) to about 99.8% (w/w), about 95% (w/w) to about 99.8% (w/w),
about 96%
(w/w) to about 99.8% (w/w), about 97% (w/w) to about 99.8% (w/w), about 98%
(w/w) to about
99.8% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about 95%
(w/w), about
25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about 25%
(w/w) to about
85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 75%
(w/w), about
25% (w/w) to about 74% (w/w), about 25% (w/w) to about 60% (w/w), about 25%
(w/w) to about
50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50%
(w/w), about
45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20%
(w/w) to about
60% (w/w), about 20% (w/w) to about 50% (w/w), about 10% (w/w) to about 50%
(w/w), or
about 10% (w/w) to about 75% (w/w) of the one or more oligosaccharides.
32. The buccal dosage form of any one of claims 29 to 31, wherein the hard
molded lozenge
comprises about 0.1% (w/w) to about 89.9% (w/w), about 0.5% (w/w) to about
89.9% (w/w),
about 1% (w/w) to about 89.9% (w/w), about 5% (w/w) to about 89.9% (w/w),
about 10% (w/w)
to about 89.9%(w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to
about 89.9%
(w/w), about 25% (w/w) to about 89.9%(w/w), about 30% (w/w) to about 89.9%
(w/w), about
35% (w/w) to about 89.9% (w/w), about 40% (w/w) to about 89.9%(w/w), about 45%
(w/w) to
about 89.9% (w/w), about 50% (w/w) to about 89.9% (w/w), about 55% (w/w) to
about
89.9%(w/w), about 60% (w/w) to about 89.9% (w/w), about 65% (w/w) to about
89.9% (w/w),
about 70% (w/w) to about 89.9%(w/w), about 75% (w/w) to about 89.9% (w/w),
about 80%
(w/w) to about 89.9% (w/w), about 85% (w/w) to about 89.9% (w/w), about 5%
(w/w) to about
50% (w/w), about 10% (w/w) to about 70%(w/w), about 15% (w/w) to about 60%
(w/w), about
20% (w/w) to about 75% (w/w), about 25% (w/w) to about 75%(w/w), 0.1% (w/w) to
about 74%
(w/w), about 40% (w/w) to about 70% (w/w), about 10% (w/w) to about 30%(w/w),
about 15%
(w/w) to about 25% (w/w), about 50% (w/w) to about 75% (w/w), about 50% (w/w)
to about
74% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80%
(w/w), about
25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about 30%
(w/w) to about
50% (w/w), about 40% (w/w) to about 50% (w/w), 40% (w/w) to about 60% (w/w),
about 45%
(w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w)
to about 60%
(w/w), about 20% (w/w) to about 50% (w/w), about 10% (w/w) to about 50% (w/w),
or about
10% (w/w) to about 75% (w/w) of the one or more polysaccharides.
33. The buccal dosage form of any one of claims 29 to 32, wherein the hard
molded lozenge
comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 10% (w/w) to about 99.8% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
134
Date Recue/Date Received 2023-06-13

(c) about 0.1% (w/w) to about 89.9% (w/w) of the one or more polysaccharides
having a
degree of polymerization up to 80 and having an average degree of
polymerization of about 9
or greater; and
(d) optionally about 0.1% (w/w) to about 5% (w/w) of the one or more
emulsifying agents.
34. The buccal dosage form of any one of claims 29 to 32, wherein the hard
molded lozenge
comprises
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 25% (w/w) to about 99.8% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 74% (w/w) of the one or more polysaccharides
having a
degree of polymerization up to 80 and having an average degree of
polymerization of about 9
or greater; and
(d) optionally about 0.1% (w/w) to about 5% (w/w) of the one or more
emulsifying agents.
35. The buccal dosage form of any one of claims 29 to 34, wherein the one or
more
oligosaccharides and the one or more polysaccharides combined comprise about
55% (w/w)
to about 99.9 % (w/w) of the hard molded lozenge.
36. The buccal dosage form of any one of claims 29 to 35, wherein the one or
more
polysaccharides have a degree of polymerization of about 2 to about 80, about
2 to about 70,
about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to
about 70, or about
to about 60.
37. The buccal dosage form of claim 36, wherein the one or more
polysaccharides have a
degree of polymerization of about 10 to about 60.
38. The buccal dosage form of claim 37, wherein the one or more
polysaccharides is inulin.
39. The buccal dosage form of any one of claims 1 to 23, wherein the hard
molded lozenge
further comprises one or more plasticizers.
40. The buccal dosage form of claim 39, wherein the hard molded lozenge
comprises about
2% (w/w) to about 15% (w/w), about 2% (w/w) to about 12% (w/w), about 2% (w/w)
to about
10% (w/w), about 2% (w/w) to about 8% (w/w), about 3 % (w/w) to about 6%
(w/w), about 4 %
(w/w) to about 8% (w/w), about 4% (w/w) to about 6% (w/w) or about 5% (w/w) of
the one or
more plasticizers.
41. The buccal dosage form of claim 39 or claim 40, wherein the one or more
plasticizers is
selected from glycerin, polyethylene glycol and combinations thereof.
42. The buccal dosage form of claim 41, wherein the one or more plasticizers
is glycerin.
135
Date Recue/Date Received 2023-06-13

43. The buccal dosage form of any one of claims 39 to 42, wherein the hard
molded lozenge
comprises about 10% (w/w) to about 97.9% (w/w), about 15% (w/w) to about 97.9%
(w/w),
about 20% (w/w) to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w),
about 30%
(w/w) to about 97.9% (w/w), about 35% (w/w) to about 97.9% (w/w), about 40%
(w/w) to about
97.9% (w/w), about 45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about
97.9% (w/w),
about 55% (w/w) to about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w),
about 65%
(w/w) to about 97.9% (w/w), about 70% (w/w) to about 97.9% (w/w), about 75%
(w/w) to about
97.9% (w/w), about 80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about
97.9% (w/w),
about 90% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), or
about 96%
(w/w) to about 97.9% (w/w) of the one or more oligosaccharides.
44. The buccal dosage form of claim 43, wherein the hard molded lozenge
comprises
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 2% (w/w) to about 15% (w/w) of the one or more plasticizers, and
(d) optionally about 0.1% (w/w) to about 3% (w/w) of the one or more
emulsifying agents.
45. The buccal dosage form of claim 44, wherein the hard molded lozenge
comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 70% (w/w) to about 97.9% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 2% (w/w) to about 10% (w/w) of the one or more plasticizers, and
(d) optionally about 0.1% (w/w) to about 3% (w/w) of the one or more
emulsifying agents.
46. The buccal dosage form of any one of claims 39 to 45, wherein the hard
molded lozenge
comprises about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9%
(w/w) or
about 95% (w/w) to about 97.9% of the one or more oligosaccharides.
47. The buccal dosage form of any one of claims 39 to 46, wherein the hard
molded lozenge
comprises:
(a) about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoid and/or
the
cannabinoid extract,
(b) about 85% (w/w) to 95% (w/w) of the one or more oligosaccharides having a
degree
of polymerization of about 10 or less;
(c) about 2% (w/w) to about 10% (w/w) of the one or more plasticizers;
136
Date Recue/Date Received 2023-06-13

(d) optionally about 0.1% (w/w) to about 1% (w/w) of the emulsifying agent;
and
(e) optionally about 0.1% (w/w) to about 1% (w/w) of the flavourant.
48. The buccal dosage form of any one of claims 39 to 42, wherein the hard
molded lozenge
further comprises one or more polysaccharides having a degree of
polymerization of up to 80
and having an average degree of polymerization of about 9 or greater.
49. The buccal dosage form of claim 48, wherein the added % (w/w) of the one
or more
polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides
in the hard
molded lozenge.
50. The buccal dosage form of claim 48 or claim 49, wherein the hard molded
lozenge
comprises about 10% (w/w) to about 97.8% (w/w), about 15% (w/w) to about 97.8%
(w/w),
about 20% (w/w) to about 97.8% (w/w), about 25% (w/w) to about 97.8% (w/w),
about 30%
(w/w) to about 97.8% (w/w), about 35% (w/w) to about 97.8% (w/w), about 40%
(w/w) to about
97.8% (w/w), about 45% (w/w) to about 97.8% (w/w), about 50% (w/w) to about
97.8% (w/w),
about 55% (w/w) to about 97.8% (w/w), about 60% (w/w) to about 97.8% (w/w),
about 65%
(w/w) to about 97.8% (w/w), about 70% (w/w) to about 97.8% (w/w), about 75%
(w/w) to about
97.8% (w/w), about 80% (w/w) to about 97.8% (w/w), about 85% (w/w) to about
97.8% (w/w),
about 90% (w/w) to about 97.8% (w/w), about 95% (w/w) to about 97.8% (w/w),
about 96%
(w/w) to about 97.8% (w/w), about 15% (w/w) to about 95% (w/w), about 20%
(w/w) to about
95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90%
(w/w), about
25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25%
(w/w) to about
75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50%
(w/w), about
30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 45%
(w/w) to about
50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w) to about 60%
(w/w), about
20% (w/w) to about 50% (w/w), about 10% (w/w) to about 50% (w/w), or about 10%
(w/w) to
about 75% (w/w) of the one or more oligosaccharides.
51. The buccal dosage form of any one of claims 48 to 50, wherein the hard
molded lozenge
comprises about 0.1% (w/w) to about 87.9% (w/w), about 0.5% (w/w) to about
87.9% (w/w),
about 1% (w/w) to about 87.9% (w/w), about 5% (w/w) to about 87.9% (w/w),
about 10% (w/w)
to about 87.9%(w/w), about 15% (w/w) to about 87.9% (w/w), about 20% (w/w) to
about 87.9%
(w/w), about 25% (w/w) to about 87.9%(w/w), about 30% (w/w) to about 87.9%
(w/w), about
35% (w/w) to about 87.9% (w/w), about 40% (w/w) to about 87.9%(w/w), about 45%
(w/w) to
about 87.9% (w/w), about 50% (w/w) to about 87.9% (w/w), about 55% (w/w) to
about
87.9%(w/w), about 60% (w/w) to about 87.9% (w/w), about 65% (w/w) to about
87.9% (w/w),
about 70% (w/w) to about 87.9%(w/w), about 75% (w/w) to about 87.9% (w/w),
about 74%
(w/w) to about 87.9% (w/w), about 80% (w/w) to about 87.9% (w/w), about 85%
(w/w) to about
87.9% (w/w), about 5% (w/w) to about 50% (w/w), about 10% (w/w) to about
70%(w/w), about
15% (w/w) to about 60% (w/w), about 20% (w/w) to about 75% (w/w), about 20%
(w/w) to about
137
Date Recue/Date Received 2023-06-13

74% (w/w), about 25% (w/w) to about 75%(w/w), about 25% (w/w) to about 75%
(w/w), 0.1%
(w/w) to about 74% (w/w), about 40% (w/w) to about 70% (w/w), about 10% (w/w)
to about
30%(w/w), about 15% (w/w) to about 25% (w/w), about 50% (w/w) to about 75%
(w/w), about
50% (w/w) to about 74% (w/w), about 25% (w/w) to about 85% (w/w), about 25%
(w/w) to about
80% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50%
(w/w), about
30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), 40% (w/w) to
about 60%
(w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w),
about 20%
(w/w) to about 60% (w/w), about 20% (w/w) to about 50% (w/w), about 10% (w/w)
to about 50%
(w/w), or about 10% (w/w) to about 75% (w/w) of the one or more
polysaccharides.
52. The buccal dosage form of any one of claims 48 to 51, wherein the hard
molded lozenge
comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 10% (w/w) to about 97.8% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 87.9% (w/w) of the one or more polysaccharides
having a
degree of polymerization of up to 80 and having an average degree of
polymerization of about
9 or greater;
(d) about 2% (w/w) to about 10% (w/w) the one or more plasticizers, and
(e) optionally about 0.1% (w/w) to about 3% (w/w) of the one or more
emulsifying agents.
53. The buccal dosage form of any one of claims 48 to 51, wherein the hard
molded lozenge
comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 25% (w/w) to about 97.9% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 74% (w/w) of the one or more polysaccharides
having a
degree of polymerization up to 80 and having an average degree of
polymerization of about 9
or greater;
(d) about 2% (w/w) to about 10% (w/w) of the one or more plasticizers, and
(e) optionally about 0.1% (w/w) to about 3% (w/w) of the one or more
emulsifying agents.
54. The buccal dosage form of any one of claims 48 to 53, wherein, the one or
more
oligosaccharides and the one or more polysaccharides comprise about 55% (w/w)
to about
97.8% (w/w) of the hard molded lozenge.
55. The buccal dosage form of any one of claims 48 to 54, wherein the one or
more
polysaccharides have a degree of polymerization of about 2 to about 80, about
2 to about 70,
138
Date Recue/Date Received 2023-06-13

about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to
about 70, or about
to about 60.
56. The buccal dosage form of claim 55, wherein the one or more
polysaccharides have a
degree of polymerization of about 10 to about 60 and the one or more
polysaccharides is inulin.
57. The buccal dosage form of any one of claims 1 to 56, wherein the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-
oligosaccharides
(GOS), gluco-oligosaccharides, arabino-oligosaccharides, manno-
oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), raffinose family of
oligosaccharides (RFO),
gluco-galacto-oligosaccharides, g luco-fructo-
oligosaccharides, gluco-manno-
oligosaccharides, gluco-arabino-oligosaccharides, gluco-xylo-oligosaccharides,
galacto-fructo-
oligosaccharides, galacto-manno-oligosaccharides, galacto-
arabino-oligosaccharides,
galacto-xylo-oligosaccharides, fructo-manno-
oligosaccharides, fructo-arabino-
oligosaccharides, fructo-xylo-oligosaccharides, manno-arabino-
oligosaccharides, manno-xylo-
oligosaccharides, arabino-xylo-oligosaccharides, and combinations thereof.
58. The buccal dosage form of claim 57, wherein the one or more
oligosaccharides are selected
from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-
oligosaccharides
(IMO), raffinose family of oligosaccharides, and combinations thereof.
59. The buccal dosage form of claim 58, wherein the one or more
oligosaccharides are selected
from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS) and
combinations
thereof.
60. The buccal dosage form of claim 59, wherein the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
61. The buccal dosage form of claim 60, wherein the FOS comprises a
heterogenous mixture
of FOS of different DPs of about 10 or less.
62. The buccal dosage form of claim 60 or claim 61, wherein the FOS comprises
inulobiose as
a naturally occurring fructo-oligosaccharide having a DP of 2.
63. The buccal dosage form of claim 57, wherein the one or more
oligosaccharides is malto-
oligosaccharide.
64. The buccal dosage form of any one of claims 1 to 62, wherein the one or
more
oligosaccharides have a degree of polymerization of about 9 or less.
65. The buccal dosage form of any one of claims 1 to 62, wherein the one or
more
oligosaccharides have a degree of polymerization of about 8 or less.
139
Date Recue/Date Received 2023-06-13

66. The buccal dosage form any one of claims 1 to 62, wherein the one or more
oligosaccharides have a degree of polymerization of about 2 to about 10, about
2 to about 9,
about 2 to about 8, about 2 to about 7, about 2 to about 6, or about 2 to
about 5.
67. The buccal dosage form of claim 66, wherein the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 10.
68. The buccal dosage form of claim 66, wherein the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 8.
69. The buccal dosage form of any one of claims 1 to 68, wherein the hard
molded lozenge
comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or
less, or about
0.5% (w/w) or less of water on a total weight of the hard molded lozenge
basis.
70. A hard molded lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more polysaccharides having a degree of polymerization of up to 80
and having
an average degree of polymerization of about 9 or greater; and
(c) one or more plasticizers.
71. The hard molded lozenge of claim 70, wherein the hard molded lozenge is
free of added
sugars, sweeteners, and/or sweetening agents.
72. The hard molded lozenge of claim 71, wherein the sugars, sweeteners,
and/or sweetening
agents are as defined in any one of claims 4 to 6.
73. The hard molded lozenge of any one of claims 70 to 72, wherein the hard
molded lozenge
comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or about
0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or the
cannabinoid extract.
74. The hard molded lozenge of any one of claims 70 to 73, wherein the hard
molded lozenge
comprises the cannabis extract as defined in claim 8 or claim 9.
75. The hard molded lozenge of any one of claims 70 to 73, wherein the hard
molded lozenge
comprises the one or more cannabinoids as defined in any one of claims 10 to
15.
76. The hard molded lozenge of any one of claims 70 to 75, wherein the hard
molded lozenge
further optionally comprises one or more emulsifying agents, one or more oils
and/or fats and/or
one or more flavourants.
77. The hard molded lozenge of claim 76, wherein one or more emulsifying
agents are as
defined in claim 17 or 18, the one or more oils and/or fats are as defined in
claim 19 and/or the
one or more flavourants are as defined in claim 20.
78. The hard molded lozenge of claim 76 or claim 77, wherein the hard molded
lozenge
comprises about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to about 2%
(w/w), about
140
Date Recue/Date Received 2023-06-13

0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or about 0.1%
(w/w) to
about 4% (w/w) of the one or more emulsifying agents.
79. The hard molded lozenge of any one of claims 76 to 78, wherein the hard
molded lozenge
comprises about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to about 2%
(w/w), about
0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or about 0.1%
(w/w) to
about 5% (w/w) of the one or more oils and/or fats.
80. The hard molded lozenge of any one of claims 76 to 79, wherein the hard
molded lozenge
comprises about 0.1% (w/w) to about 1.5% (w/w) or about 0.1% (w/w) to about 2%
(w/w) of the
one or more flavourants.
81. The hard molded lozenge of any one of claims 70 to 79, wherein the hard
molded lozenge
comprises about 10% (w/w) to about 97.9% (w/w), about 15% (w/w) to about 97.9%
(w/w),
about 20% (w/w) to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w),
about 30%
(w/w) to about 97.9% (w/w), about 35% (w/w) to about 97.9% (w/w), about 40%
(w/w) to about
97.9% (w/w), about 45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about
97.9% (w/w),
about 55% (w/w) to about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w),
about 65%
(w/w) to about 97.9% (w/w), about 70% (w/w) to about 97.9% (w/w), about 75%
(w/w) to about
97.9% (w/w), about 80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about
97.9% % (w/w),
about 90% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w),
about 96%
(w/w) to about 97.9% (w/w), or about 97% (w/w) to about 97.9% (w/w) of the one
or more
polysaccharides.
82. The hard molded lozenge of any one of claims 70 to 80, wherein the hard
molded lozenge
comprises about 2% (w/w) to about 15% (w/w), about 2 % (w/w) to about 12%
(w/w), about 2%
(w/w) to about 10% (w/w), about 2% (w/w) to about 8% (w/w), about 3 % (w/w) to
about 6%
(w/w), about 4% (w/w) to about 8% (w/w), about 4% (w/w) to about 6% (w/w) or
about 5% (w/w)
of the one or more plasticizers.
83. The hard molded lozenge of any one of claims 70 to 82, wherein the hard
molded
comprises:
(a) about 0.1% (w/w) to about 2% of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 85% (w/w) to about 97.9% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to 80 and having an average degree of polymerization
of about 9 or
greater;
(c) about 2% (w/w) to about 15% (w/w) of one or more plasticizers, and
(d) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying
agents.
84. The hard molded lozenge of claim 83, wherein the one or more plasticizers
is selected from
glycerin, polyethylene glycol and combinations thereof.
141
Date Recue/Date Received 2023-06-13

85. The hard molded lozenge form of claim 84, wherein the one or more
plasticizers is glycerin.
86. The hard molded lozenge of any one of claims 70 to 85, wherein the one or
more
polysaccharides have a degree of polymerization of about 2 to about 80, about
2 to about 70,
about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to
about 70, or about
to about 60.
87. The hard molded lozenge of claim 86, wherein the one or more
polysaccharides have a
degree of polymerization of about 10 to about 60 and the one or more
polysaccharides is inulin.
88. The hard molded lozenge of any one of claims 70 to 87, wherein hard molded
lozenge
comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or
less, or about
0.5% (w/w) or less of water on a total weight of the hard molded lozenge
basis.
89. The buccal dosage form of claim 1, wherein the buccal dosage form is a
soft chew lozenge,
the soft chew lozenge comprising:
(a) the one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 90% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents.
90. The buccal dosage form of claim 89, wherein the soft chew lozenge further
comprises
about 5% (w/w) to about 70% (w/w), about 10% (w/w) to about 70% (w/w), about
10% (w/w) to
about 65% (w/w), about 10% (w/w) to about 60% (w/w), about 10% (w/w) to about
55% (w/w),
about 10% (w/w) to about 55% (w/w), about 10% (w/w) to about 50% (w/w), about
10% (w/w)
to about 45% (w/w), about 10% (w/w) to about 40% (w/w), about 10% (w/w) to
about 35% (w/w),
about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 25% (w/w), or
about 10% (w/w)
to about 20% (w/w) of water.
91. The buccal dosage form of claim 90, wherein the soft chew lozenge
comprises about 10%
(w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water, or
about 10%
(w/w) to about 20% (w/w) water.
92. The buccal dosage form of any one of claims 89 to 91, wherein the soft
chew lozenge
comprises the cannabis extract as defined in claim 8 or claim 9 and/or the one
or more
cannabinoids are as defined in any one of claims 10 to 15.
93. The buccal dosage form of any one or claims 89 to 92, wherein the soft
chew lozenge
comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 70% (w/w) to about 90% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
142
Date Recue/Date Received 2023-06-13

(c) about 1% (w/w) to about 25% (w/w) of the one or more gelling agents.
94. The buccal dosage form of claim 93, wherein the soft chew lozenge
comprises about 75%
(w/w), about 80% (w/w), about 85% (w/w), or about 90% (w/w) of the one or more
oligosaccharides.
95. The buccal dosage form of any one of claims 89 to 94, wherein the soft
chew lozenge
comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or about
0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or the
cannabinoid extract.
96. The buccal dosage form of any one of claims 89 to 95, wherein the soft
chew lozenge
comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 10% (w/w) to about 90% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of the one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
97. The buccal dosage form of claim 96, wherein the soft chew lozenge
comprises about 15%
(w/w) to about 90% (w/w), about 20% (w/w) to about 90% (w/w), about 25% (w/w)
to about 90%
(w/w), about 30% (w/w) to about 90% (w/w), about 40 (w/w) to about 90% (w/w),
about 45%
(w/w) to about 90% (w/w), about 50% (w/w) to about 90% (w/w), about 55% (w/w)
to about 90%
(w/w), about 65% (w/w) to about 90% (w/w), about 70% (w/w) to about 90% (w/w),
about 75%
(w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or about 85%
(w/w) to about
90% (w/w) of the one or more oligosaccharides.
98. The buccal dosage form of claim 97, wherein the soft chew lozenge
comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 70% (w/w) to about 90% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of the one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of the one or more
emulsifying agents;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of the one or more oils
and/or fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of the one or more pH
modifying agents.
143
Date Recue/Date Received 2023-06-13

99. The buccal dosage form of claim 98, wherein the soft chew lozenge
comprises about 75%
(w/w) to about 90% (w/w), or about 80% (w/w) to about 90% (w/w) of the one or
more
oligosaccharides.
100. The buccal dosage form of any one of claims 89 to 92, wherein the soft
chew lozenge
further comprises one or more polysaccharides having a degree of
polymerization of up to 80
and having an average degree of polymerization of about 9 or greater.
101. The buccal dosage form of claim 100, wherein the added % (w/w) of the one
or more
polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides
in the soft
chew lozenge.
102. The buccal dosage form of claim 99 or claim 100, wherein the soft chew
lozenge
comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract;
(b) about 10% (w/w) to about 89.9% (w/w) of the one or more oligosaccharides
having
a of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of the one or more gelling agents; and
(d) about 0.1% (w/w) to about 80% (w/w) of the one or more polysaccharides
having a
degree of polymerization of up to 80 and having an average degree of
polymerization
of about 9 or greater.
103. The buccal dosage form of claim 102, wherein the soft chew lozenge
comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
a
cannabinoid extract;
(b) about 10% (w/w) to about 89.9% (w/w) of the one or more oligosaccharides
having
a degree of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of the one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 80% (w/w) of the one or more
polysaccharides
having a degree of polymerization up to 80 and having an average degree of
polymerization of about 9 or greater;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(f) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(g) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
104. The buccal dosage form of any one of claims 100 to 103, wherein the one
or more
polysaccharides have a degree of polymerization of about 2 to about 80, about
2 to about 70,
about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to
about 60, about 10
to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about
20.
144
Date Recue/Date Received 2023-06-13

105. The buccal dosage form of any one of claims 100 to 103, wherein the one
or more
polysaccharides have an average degree of polymerization of about 10 or
greater.
106. The buccal dosage form of any one of claims 100 to 105, wherein the soft
chew lozenge
comprises about 0.5% (w/w) to about 80% (w/w), about 1% (w/w) to about 80%
(w/w), about
5% (w/w) to about 80% (w/w), about 10% (w/w) to about 80%(w/w), about 15%
(w/w) to about
80% (w/w), about 20% (w/w) to about 80% (w/w), about 25% (w/w) to about
80%(w/w), about
30% (w/w) to about 80% (w/w), about 35% (w/w) to about 80% (w/w), about 40%
(w/w) to about
80%(w/w), about 45% (w/w) to about 80% (w/w), about 50% (w/w) to about 80%
(w/w), about
55% (w/w) to about 80%(w/w), about 60% (w/w) to about 80% (w/w), about 65%
(w/w) to about
80% (w/w), about 70% (w/w) to about 80%(w/w), or about 75% (w/w) to about 80%
(w/w) of the
one or more polysaccharides.
107. The buccal dosage form of any one of claims 100 to 106, wherein the soft
chew lozenge
comprises about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to about 89.9%
(w/w),
about 25% (w/w) to about 89.9% (w/w), about 30% (w/w) to about 89.9% (w/w),
about 40%
(w/w) to about 89.9% (w/w), about 55% (w/w) to about 89.9% (w/w), about 65%
(w/w) to about
89.9% (w/w), about 70% (w/w) to about 89.9% (w/w), about 75% (w/w) to about
89.9% (w/w),
about 80% (w/w) to about 89.9% (w/w), about 85% (w/w) to about 89.9% (w/w),
about 45%
(w/w) to about 80% (w/w), about 50% (w/w) to about 80% (w/w) or about 55%
(w/w) to about
80% (w/w) of the one or more oligosaccharides.
108. The buccal dosage form of any one of claims 100 to 107, wherein the one
or more
oligosaccharides and the one or more polysaccharides combined comprise about
55% (w/w)
to about 90% (w/w), about 60% (w/w) to about 90% (w/w), about 65% (w/w) to
about 90% (w/w),
about 65% (w/w) to about 90% (w/w), about 70% (w/w) to about 90% (w/w), about
80% (w/w)
to about 90% (w/w), or about 85% (w/w) to about 90% (w/w) of the total weight
of the soft chew
lozenge.
109. The buccal dosage form of any one of claims 100 to 108, wherein the one
or more
oligosaccharides and the one or more polysaccharides combined comprise about
55% (w/w)
to about 90% (w/w) of the soft chew lozenge.
110. The buccal dosage form of any one of claims 100 to 109, wherein the one
or more
polysaccharides is inulin, and the inulin has a degree of polymerization of up
to 60.
111. The buccal dosage form of claim 110, wherein the inulin has a degree of
polymerization
of about 2 to about 60, about 3 to about 60, or about 10 to about 60.
112. The buccal dosage form of any one of claims 89 to 111, wherein the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-
oligosaccharides
(GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-
oligosaccharides (IMO), raffinose family of oligosaccharides, and combinations
thereof.
145
Date Reçue/Date Received 2023-06-13

113. The buccal dosage form of claim 112, wherein the one or more
oligosaccharides are
selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS)
and
combinations thereof.
114. The buccal dosage form of claim 113, wherein the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
115. The buccal dosage form of any one of claims 89 to 114, wherein the one or
more
oligosaccharides have a degree of polymerization of about 9 or less.
116. The buccal dosage form of any one of claims 89 to 114, wherein the one or
more
oligosaccharides have a degree of polymerization of about 2 to less than or
equal to 10.
117. The buccal dosage form of any one of claims 89 to 114, wherein the one or
more
oligosaccharides have a degree of polymerization of about 2 to about 10, about
2 to about 9,
about 2 to about 8, about 2 to about 7, about 2 to about 6, or about 2 to
about 5.
118. The buccal dosage form of any one of claims 89 to 114, wherein the one or
more
oligosaccharides have a degree of polymerization of about 2 to about 10.
119. The buccal dosage form of any one of claims 89 to 114, wherein the one or
more
oligosaccharides have a degree of polymerization of about 2 to about 8.
120. The buccal dosage form of any one of claims 89 to 119, wherein the soft
chew lozenge
comprises of from about 1% (w/w) to about 10% (w/w), about 2% (w/w) to about
10% (w/w), or
from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents.
121. The buccal dosage form of claim 120, wherein the one or more gelling
agent is gelatin.
122. The buccal dosage form of any one of claims 89 to 121, wherein the soft
chew lozenge is
free of added sugars, sweeteners and/or sweetening agents.
123. The buccal dosage form of claim 122, wherein the sugars, sweeteners,
and/or sweetening
agents are as defined in any one of claims 4 to 6.
124. The buccal dosage form of any one of claims 89 to 122, wherein the soft
chew lozenge
further optionally comprises the one or more emulsifying agents as defined in
claim 17 or 18,
the one or more oils and/or fats as defined in claim 19 and/or the one or more
flavourants as
defined in claim 20.
125. The buccal dosage form of claim 124, wherein the soft chew lozenge
further comprises
about 0.1 % (w/w) to about 1.0%(w/W) or less of the one or more emulsifying
agents.
126. The buccal dosage form of claim 124, wherein the soft chew lozenge
further comprises
0.1% (w/w) to about 5% (w/w) of the one or more oils and/or fats.
146
Date Recue/Date Received 2023-06-13

127. The buccal dosage form of any one of claims 96 to 99 and 103 to 111,
wherein the soft
chew lozenge comprises about 0.1%(w/w) to about 2%(w/w) or less of one or more
pH
modifying agents.
128. The buccal dosage form of claim 127, wherein the one or more pH modifying
agents are
selected from citric acid, malic acid, tartaric acid, ascorbic acid and
combinations thereof.
129. The buccal dosage form of claim 124, wherein the soft chew lozenge
comprises 0.1%
(w/w) to about 2% (w/w) or less of the one or more flavourants.
130. The buccal dosage form of claim 1 wherein the buccal dosage form is a
compressed tablet
lozenge, the compressed tablet lozenge comprising:
(a) the one or more cannabinoids, and/or the cannabinoid extract; and
(b) about 10% (w/w) to about 98% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
131. The buccal dosage form of claim 130, wherein the compressed tablet
lozenge
comprises about 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or
less, about 0.5%
(w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about
0.1% (w/w) or less
of the one or more cannabinoids, and/or the cannabinoid extract.
132. The buccal dosage form of claim 130 or claim 131, wherein the compressed
tablet lozenge
further comprises one or more lubricants.
133. The buccal dosage form of claim 132, wherein the compressed tablet
lozenge comprises
about 0.1% (w/w) to about 5%(w/w) of the one or more lubricants.
134. The buccal dosage form of any one of claims 130 to 133, wherein the
compressed
tablet lozenge comprises:
(a) the one or more cannabinoids, and/or the cannabinoid extract; and
(b) about 80% (w/w) to about 98% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
135. The buccal dosage form of claim 134, wherein the compressed tablet
lozenge comprises
about 85% (w/w) to about 98% (w/w), about 90% (w/w) to about 95% (w/w), or
about 92% (w/w)
to about 95% (w/w) of the one or more oligosaccharides.
136. The buccal dosage form of claim 132 or claim 133, wherein the
compressed tablet
lozenge comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 10% (w/w) to about 98% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
147
Date Recue/Date Received 2023-06-13

(c) optionally 0.1% (w/w) to about 5%(w/w) of the one or more lubricants;
(d) optionally 0.1% (w/w) to about 2% (w/w) of one or more emulsifying agents;
and
(e) optionally 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats.
137. The buccal dosage form of claim 136, wherein the compressed tablet
lozenge
comprises about 85% (w/w) to about 98% (w/w), about 90% (w/w) to about 98%
(w/w), about
95% (w/w) to about 98% (w/w), about 96% (w/w) to about 98% (w/w) or about 97%
(w/w) to
about 98% (w/w) of the one or more oligosaccharides.
138. The buccal dosage form of claim 136, wherein the compressed tablet
lozenge comprises:
(a) about 0.1% (w/w) to about 2% (w/w) of the one or more cannabinoids, and/or
the
cannabinoid extract;
(b) about 80% (w/w) to about 98% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) optionally 0.1% (w/w) to about 5% (w/w) of the one or more lubricants;
(d) optionally 0.1% (w/w) to about 2% (w/w) of the one or more emulsifying
agents; and
(e) optionally 0.1% (w/w) to about 2% (w/w) of the one or more oils and/or
fats.
139. The buccal dosage form of claim 138, wherein the compressed tablet
lozenge comprises
about 85% (w/w) to about 98% (w/w), about 90% (w/w) to about 95% (w/w), or
about 92% (w/w)
to about 95% (w/w) of the one or more oligosaccharides.
140. The buccal dosage form of any one of claims 130 to 134, wherein the
compressed tablet
lozenge further comprises one or more polysaccharides having a degree of
polymerization of
up to 80 and having an average degree of polymerization of about 9 or greater.
141. The buccal dosage form of claim 140, wherein the added % (w/w) of the one
or more
polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides
in the buccal
dosage form.
142. The buccal dosage form of claim 140 or claim 141, wherein the compressed
tablet lozenge
comprises:
(a) the one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) about 0.1% (w/w) to about 88% (w/w) of the one or more polysaccharides
having a
degree of polymerization of up to 80 and having an average degree of
polymerization of about
9 or greater.
143. The buccal dosage form of claim 141, wherein the compressed tablet
lozenge comprises:
148
Date Recue/Date Received 2023-06-13

(a) the one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of the one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 88% (w/w) of the one or more polysaccharides
having a
degree of polymerization of up to 80 and having an average degree of
polymerization of about
9 or greater;
(d) optionally 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(e) optionally 0.1% (w/w) to about 2% (w/w) of one or more emulsifying agents;
and
(f) optionally 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats.
144. The buccal dosage form of any one of claims 140 to 143, wherein the one
or more
polysaccharides have a degree of polymerization of about 2 to about 80, about
2 to about 70,
about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to
about 60, about 10
to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about
20.
145. The buccal dosage form of claim 144, wherein the one or more
polysaccharides have a
degree of polymerization of about 10 to about 60.
146. The buccal dosage form of any one of claims 140 to 145, wherein the one
or more
polysaccharides have an average degree of polymerization of about 10 or
greater.
147. The buccal dosage form of any one of claims 140 to 146, wherein the
compressed tablet
lozenge comprises about 70% (w/w) to about 97.9% (w/w), about 75% (w/w) to
about 97.9%
(w/w), about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9%
(w/w), about
95% (w/w) to about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w) or about
97% (w/w)
to about 97.9% (w/w) of the one or more oligosaccharides.
148. The buccal dosage form of any one of claims 140 to 147, wherein the
compressed tablet
lozenge comprises about 0.5% (w/w) to about 88% (w/w), about 1% (w/w) to about
88% (w/w),
about 5% (w/w) to about 88% (w/w), about 10% (w/w) to about 88%(w/w), about
15% (w/w),
about 88% (w/w), about 20% (w/w) to about 88% (w/w), about 25% (w/w) to about
88%(w/w),
about 30% (w/w) to about 88% (w/w), about 35% (w/w) to about 88% (w/w), about
40% (w/w)
to about 88%(w/w), about 45% (w/w) to about 88% (w/w), about 50% (w/w) to
about 88% (w/w),
about 55% (w/w) to about 88%(w/w), about 60% (w/w) to about 88% (w/w), about
65% (w/w)
to about 88% (w/w), about 70% (w/w) to about 88%(w/w), about 75% (w/w) to
about 88% (w/w),
about 80% (w/w) to about 88% (w/w) or about 85% (w/w) to about 88% (w/w) of
the one or
more polysaccharides.
149. The buccal dosage form of any one of claims 140 to 148, wherein the one
or more
oligosaccharides and the one or more polysaccharides combined comprise about
90% (w/w)
to about 98% (w/w) of the compressed tablet lozenge.
149
Date Recue/Date Received 2023-06-13

150. The buccal dosage form of claim 149, wherein the one or more
oligosaccharides and the
one or more polysaccharides combined comprise about 90% (w/w) to about 97%
(w/w), about
90% (w/w) to about 96% (w/w), or about 90% (w/w) to about 95% of the
compressed tablet
lozenge.
151. The buccal dosage form of any one of claims 140 to 147, wherein the one
or more
polysaccharides is inulin, and the inulin has a degree of polymerization of up
to 60.
152. The buccal dosage form of claim 151, wherein the inulin has a degree of
polymerization
of about 2 to about 60, about 3 to about 60, or about 10 to about 60.
153. The buccal dosage form of any one of claims 130 to 152, wherein the one
or more
cannabinoid extracts are as defined in claim 8 or claim 9.
154. The buccal dosage form of any one of claims 130 to 153, wherein the one
or more
cannabinoids are as defined in any one of claims 10 to 15.
155. The buccal dosage form of any one of claims 130 to 154, wherein the one
or more
oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-
oligosaccharides
(GOS), arabino-ofigosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-
oligosaccharides (IMO), raffinose family of oligosaccharides, and combinations
thereof.
156. The buccal dosage form of claim 155, wherein the one or more
oligosaccharides are
selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS)
and
combinations thereof.
157. The buccal dosage form of claim 156, wherein the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
158. The buccal dosage form of any one of claims 130 to 157, wherein the one
or more
oligosaccharides have a degree of polymerization of about 9 or less, about 8
or less, about 7
or less or about 6 or less or about 5 or less.
159. The buccal dosage form of any one of claims 130 to 158, wherein the one
or more
oligosaccharides have a degree of polymerization of about 2 to about 10.
160. The buccal dosage form of any one of claims 130 to 158, wherein the one
or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8,
about 2 to about 7, about 2 to about 6, or about 2 to about 5.
161. The buccal dosage form of any one of claims 130 to 158, wherein the one
or more
oligosaccharides have a degree of polymerization of about 2 to less than or
equal to 10.
162. The buccal dosage form of any one of claims 130 to 158, wherein the one
or more
oligosaccharides have a degree of polymerization of about 2 to less than or
equal to 8.
163. The buccal dosage form of any one of claims 130 to 162, wherein the
compressed tablet
lozenge is free of added sugars, sweeteners and/or sweetening agents.
150
Date Reçue/Date Received 2023-06-13

164. The buccal dosage form of claim 163, wherein the sugars, sweeteners,
and/or sweetening
agents are as defined in any one of claims 4 to 6.
165. The buccal dosage form of any one of claims 130 to 164, wherein the
compressed tablet
lozenge comprises about 5% (w/w) or less of the one or more lubricants.
166. The buccal dosage form of any one of claims 165, wherein the one or more
lubricants is
magnesium stearate.
167. The buccal dosage form of any one of claims 130 to 166, wherein the
compressed tablet
lozenge further comprises about 2% (w/w) or less of one or more emulsifying
agents.
168. The buccal dosage form of claim 167, wherein the compressed tablet
lozenge further
comprises about 1.0% (w/w) or less of the one or more emulsifying agents.
169. The buccal dosage form of claim 167 or claim 168, wherein the one or more
emulsifying
agents are as defined in claim 17 or claim 18.
170. The buccal dosage form of claim 169, wherein the one or more emulsifying
agents is
lecithin and the lecithin is soy lecithin or sunflower lecithin.
171. The buccal dosage form of any one of claims 130 to 135 and 140 to 142,
wherein the
compressed tablet lozenge further comprises about 2% (w/w) or less of one or
more oils and/or
fats.
172. The buccal dosage form of any one of claims 136 to 138 and 143 to 170,
wherein the
compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more
oils and/or
fats.
173. The buccal dosage form of claim 171 or claim 72, wherein the one or more
oils are
vegetable oils.
174. The buccal dosage form of any one of claims 130 to 173, wherein the
compressed tablet
lozenge further comprises about 1% (w/w) or less of one or more pH modifying
agents.
175. The buccal dosage form of any one of claims 130 to 174, wherein the
compressed tablet
lozenge further comprises about 1% (w/w) or less of one or more flavourants.
176. The buccal dosage form of claim 175, wherein the one or more flavourants
are as defined
in claim 20.
177. A hard molded lozenge comprising about 0.1% (w/w) to about 2% (w/w) of
one or more
cannabinoids, and/or a cannabinoid extract, about 90% (w/w) to about 99.9%
(w/w) of one or
more oligosaccharides having a degree of polymerization of about 2 to about 9
selected from
fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides,
manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides
(IMO), raffinose
family of oligosaccharides, and combinations thereof, optionally about 0.1%
(w/w) to about
151
Date Recue/Date Received 2023-06-13

0.2% (w/w) of an emulsifying agent, optionally about 0.1% (w/w) to about 2%
(w/w) of one or
more oils and/or fats and optionally about 0.1% (w/w) to about 1% (w/w) of a
flavourant.
178. A hard molded lozenge comprising about 0.1% (w/w) to about 2% (w/w) of
one or more
cannabinoids, and/or a cannabinoid extract; about 90% (w/w) to about 96% of
one or more
oligosaccharides having a degree of polymerization of about 2 to about 9
selected from fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO),
raffinose family of
oligosaccharides, and combinations thereof; about 3% (w/w) to about 6% (w/w)
of glycerin;
optionally about 0.1% (w/w) to about 0.5% (w/w) of an emulsifying agent; and
optionally about
0.1% (w/w) to about 1% (w/w) of a flavourant.
179. A hard molded lozenge comprising about 0.1% (w/w) to about 2% (w/w) of
one or more
cannabinoids, and/or a cannabinoid extract; about 40% (w/w) to about 60% of
one or more
oligosaccharides having a degree of polymerization of about 2 to about 9
selected from fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO),
raffinose family of
oligosaccharides, and combinations thereof; about 40% (w/w) to about 60% of
inulin having a
degree of polymerization of up to 60 and having an average degree of
polymerization of about
9 or greater or about 10 or greater; about 3 % (w/w) to about 6% (w/w) of
glycerin; optionally
about 0.1% to about 0.5% of an emulsifying agent; and optionally about 0.1% to
about 1% of a
flavourant, wherein the one or more oligosaccharides and the one or more
polysaccharides
combined comprise about 90% (w/w) to about 96% (w/w) of the hard molded
lozenge.
180. A hard molded lozenge comprising about 0.1% (w/w) to about 2% (w/w) of
one or more
cannabinoids, and/or a cannabinoid extract; about 90% (w/w) to about 95% (w/w)
of inulin
having a degree of polymerization of up to 60 and having an average degree of
polymerization
of about 9 or greater; about 3% (w/w) to about 6% (w/w) of glycerin;
optionally about 0.1 %
(w/w) to about 0.5% (w/w) of an emulsifying agent; and optionally about 0.1%
(w/w) to about
1% (w/w) of a flavourant.
181. The hard molded lozenge of any one of claims 177 to 179, wherein the of
one or more
oligosaccharides is FOS.
182. The hard molded lozenge of any one of claims 177 to 181, wherein the one
or more
cannabinoids is THC and the hard molded lozenge comprises about 10mg of THC.
183. A use of a buccal dosage form of any one of claims 1 to 176 or a hard
molded lozenge of
any one of claims 177 to 182 for treating diseases, disorders or conditions
that benefit from
treatment from one or more cannabinoids and/or cannabinoid extract.
184. A use of a buccal dosage form of any one of claims 1 to 176 or a hard
molded lozenge of
any one of claims 177 to 182 for manufacturing a medicament for treating
diseases, disorders
152
Date Recue/Date Received 2023-06-13

or conditions that benefit from treatment from one or more cannabinoids and/or
cannabinoid
extract.
185. Buccal dosage form of any one of claims 1 to 176 or hard molded lozenge
of any one of
claims 177 to 182 for use for treating diseases, disorders or conditions that
benefit from
treatment from one or more cannabinoids and/or cannabinoid extract.
186. A method of preparing the hard molded lozenges of any one of claims 1 to
88 and 177 to
182 comprising:
a) mixing the one or more oligosaccharides with water to obtain an
oligosaccharide
mixture;
(b) heating the oligosaccharide mixture to a suitable temperature until about
95% (w/w)
to about 99.9% (w/w) of the water is removed;
(c) cooling the oligosaccharide mixture to a suitable temperature;
(d) adding the one or more cannabinoids, and/or a cannabinoid extract to the
oligosaccharide mixture with mixing to obtain a bulk lozenge product; and
(e) shaping or molding the bulk lozenge product to form the hard molded
lozenges, and
the method further comprising
when one or more plasticizers is present, adding the one or more plasticizers
with mixing
to the cooled oligosaccharide mixture in step (d), or adding the one or more
plasticizers, all or
in part, with heating in step (b) prior to reaching the suitable temperature,
and
when one or more polysaccharides is present, mixing the one or more
polysaccharides
with the one or more oligosaccharides if present with the water in step (a).
187. The method of claim 186, wherein, in the alternative, step (d) comprises
mixing the one or
more cannabinoids, and/or a cannabinoid extract with one or more emulsifying
agents and/or
one or more oils and/or fats to form a cannabinoid mixture, and adding the
cannabinoid mixture
to the to the oligosaccharide mixture to obtain a bulk lozenge product.
188. The method of claim 186 or 187, wherein, in the alternative, step (a)
comprises mixing the
one or more polysaccharides with water to obtain a polysaccharides mixture,
and steps (b) to
(e) are performed with the polysaccharide mixture.
189. A hard molded lozenges of any one of claims 1 to 88 and 172 to 177
prepared by the
method of any one of claims 186 to 188.
190. A method of preparing the soft chew lozenges of any one of claims 89 to
129 comprising:
(a) mixing the one or more gelling agents wherein the gelling agent is gelatin
with water
and allowing the gelling agent to hydrate to form a gelling mixture;
153
Date Recue/Date Received 2023-06-13

(b) adding the one or more oligosaccharides to the gelling mixture to obtain
an
oligosaccharide/gel mixture;
(c) heating the oligosaccharide/gel mixture;
(d) removing the oligosaccharide/gel mixture from the heat;
(e) adding one or more cannabinoids, and/or a cannabinoid extract to the
oligosaccharide/gel mixture to obtain a cannabinoid/oligosaccharide mixture;
(f) mixing the cannabinoid/oligosaccharide mixture; and
(g) molding the homogenous cannabinoid/oligosaccharide mixture to form the
soft chew
lozenges.
191. A method of preparing the soft chew lozenges of any one of claims 89 to
129 comprising:
(a) mixing the one or more gelling agents wherein the gelling agent is gelatin
with water
and allowing the gelling agent to hydrate to form a gelling mixture;
(b) mixing the one or more oligosaccharides with water to obtain an
oligosaccharide
mixture;
(c) heating the oligosaccharide mixture;
(d) adding one or more cannabinoids, and/or a cannabinoid extract and the
gelling mixture
to the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide
mixture;
(e) mixing the cannabinoid/oligosaccharide mixture; and
(f) molding the cannabinoid/oligosaccharide mixture to form the soft chew
lozenges.
192. A soft chew lozenge of any one of claims 89 to 129 prepared by the method
of claim 190
or claim 191.
193. A method of preparing the compressed tablet lozenges of any one of claims
130 to 176
comprising:
(a) combining the one or more cannabinoids, and/or the cannabinoid extract and
the one
or more oligosaccharides to obtain a cannabinoid/oligosaccharide mixture;
(b) mixing the cannabinoid/oligosaccharide mixture;
(c) adding the lubricant to the cannabinoid/oligosaccharide mixture and mixing
to obtain a
lubricated cannabinoid/oligosaccharide mixture;
(d) pressing the lubricated cannabinoid/oligosaccharide mixture to form the
compressed
tablet lozenges.
194. A compressed tablet lozenge of any one of claims 130 to 176 prepared by
the method of
claim 193.
154
Date Recue/Date Received 2023-06-13

195. A method of reclaiming rework produced from preparing the hard molded
lozenges of any
one of claims 1 to 88 and 177 to 182 comprising:
heating the rework produced from preparing the hard molded lozenges of any one
of
claims 1 to 88 and 177 to 182 to a suitable temperature to melt the rework to
provide a bulk
lozenge product;
optionally cooling the bulk lozenge product to temperature suitable for
shaping; and
shaping or molding the bulk lozenge product to form the hard molded lozenges.
155
Date Recue/Date Received 2023-06-13

Description

TITLE: BUCCAL DOSAGE FORMS COMPRISING OLIGOSACCHARIDES
FIELD
[001] The present application relates to buccal dosage of one or more
cannabinoids, and/or a
cannabinoid extract and one or more oligosaccharides such as fructo-
oligosaccharide and
optionally with one or more polysaccharides and/or glycerin and to methods of
preparation
thereof. The present application also relates to buccal dosage forms
comprising one or more
polysaccharides such as inulin and a plasticizer such glycerin. More
particularly, the buccal
dosage forms are hard molded lozenges, soft chew lozenges, and/or compressed
tablets.
BACKGROUND
[002] The increasing legalization of cannabis for medical and recreational
uses in North
America and various jurisdictions around the world will lead to increased use
of both medical and
recreational marijuana and increased demand and need for alternative dosage
forms. The
cannabis industry has been traditionally dominated by formats such as dried
flower, prerolls, and
whole plant extracts in carrier oil; over the past several years, processed
ingestible formats such
as cannabis-infused capsules, softgels, confectionary, and beverages have
gained mainstream
visibility in markets in North America and elsewhere. Despite these advances,
there remains a
demand for buccal dosage forms that can be manufactured and distributed at
scale with relative
ease, and/or exhibits desirable end-product characteristics, and/or present
health or nutritional
advantages. For instance, health conscience consumers may favour reduced
calorie
formulations or formulations that comprise prebiotics to promote gut
microflora, while
manufacturers may favour formulations that confer manufacturing advantages
such as improved
workability and reworking efficiency as well as finished product traits such
as improved
dissolution. Accordingly, there is a need for new cannabis formulations for
oral administration
having, for example, one or more of these features.
SUMMARY
[003] Buccal dosage forms such as hard molded lozenge, soft chew lozenges, and
compressed tablets comprising one or more cannabinoid and/or cannabinoid
extracts and one
or more oligosaccharides such as fructo-oligosaccharide alone or in
combination with one or
more polysaccharides such as inulin, and optionally including a plasticizer
such as glycerin have
been prepared. Buccal dosage forms comprising one or more polysaccharides such
as inulin
and a plasticizer such glycerin have also been prepared. Accordingly, the
present application
includes a buccal dosage form comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less.
[004] The present application also includes a buccal dosage wherein the buccal
dosage form
is a hard molded lozenge comprising:
1
Date Recue/Date Received 2021-08-20

(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 95% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents; and
(d) optionally about 0.1% (w/w) to about 2% (w/w) of one or more oils and/or
fats.
[005] The present application also includes a buccal dosage wherein the buccal
dosage form
is a hard molded lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 99.8% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 89.9% (w/w) of one or more polysaccharides
having a degree
of polymerization up to about 80 and having an average degree of
polymerization of about 9 or
greater, and
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents.
[006] The present application also includes a buccal dosage wherein the buccal
dosage form
is a hard molded lozenge comprising:
(a) about 0.1% (w/w) to about 1% of one or more cannabinoid and/or cannabinoid
extract,
(b) about 85% (w/w) to 95% (w/w) of one or more oligosaccharides having a
degree of
polymerization of about 10 or less;
(c) about 2 % (w/w) to about 10% (w/w) of one or more plasticizers;
(d) optionally about 0.1 (w/w) to about 1% (w/w) of an emulsifying agent; and
(e) optionally about 0.1% (w/w) to about 1% (w/w) of a flavourant.
[007] The present application also includes a buccal dosage wherein the buccal
dosage form
is a hard molded lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.8% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 87.9% (w/w) of one or more polysaccharides
having a degree
of polymerization of up to about 80 and having an average degree of
polymerization of about 9
or greater;
(d) about 2% (w/w) to about 10% (w/w) one or more plasticizers, and
2
Date Recue/Date Received 2021-08-20

(e) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[008] The present application also includes a hard molded lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more polysaccharides having a degree of polymerization of up to
about 80 and
having an average degree of polymerization of about 9 or greater; and
(c) one or more plasticizers.
[009] The present application also includes a hard molded lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 85% (w/w) to about 97.9% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to about 80 and having an average degree of
polymerization of about 9
or greater;
(c) about 2% (w/w) to about 15% (w/w) of one or more plasticizers, and
(d) optionally about 0.1 (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[0010] The present application also includes a buccal dosage form wherein the
buccal dosage
form is a soft chew lozenge, the soft chew lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less; and
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents.
[0011] In an embodiment, the present application includes a soft chew lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 70% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less; and
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents.
[0012] In an embodiment, the present application includes a soft chew lozenge
comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 10% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
3
Date Recue/Date Received 2021-08-20

(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
[0013] In an embodiment, the present application includes a soft chew lozenge
comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 10% (w/w) to about 89.9% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 80% (w/w) of one or more
polysaccharides having
a degree of polymerization up to about 80 and having an average degree of
polymerization of
about 9 or greater;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
[0014] The present application also includes a buccal dosage form wherein the
buccal dosage
form is a compressed tablet lozenge, the compressed tablet lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 10% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less.
[0015] In an embodiment, the present application includes a compressed tablet
lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 80% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or more.
[0016] In an embodiment, the present application includes a compressed tablet
lozenge
comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 10% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less;
(c) optionally 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(d) optionally 0.1% (w/w) to about 2% (w/w) of one or more emulsifying agents;
and
4
Date Recue/Date Received 2021-08-20

(e) optionally 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats.
[0017] In an embodiment, the present application includes a compressed tablet
lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 88% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to about 80 and having an average degree of
polymerization of about 9
or greater;
(d) optionally 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(e) optionally 0.1% (w/w) to about 2% (w/w) of one or more emulsifying agents;
and
(f) optionally 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats.
[0018] In an embodiment, the buccal dosage forms have been prepared without
any added
sugars, sweeteners, or sweetening agents.
[0019] The present application also includes a method of treating diseases,
disorders or
conditions that benefit from treatment from one or more cannabinoids and/or
cannabinoid extract.
[0020] The present application also includes methods of preparing the buccal
dosage forms of
the application.
[0021] In an embodiment, the buccal dosage forms of the present application
optionally
comprises, consists of, or consists essentially of the embodiments described
herein.
[0022] Other features and advantages of the present application will become
apparent from the
following detailed description. However, it should be understood that the
detailed description and
the specific examples, while indicating embodiments of the application, are
given by way of
illustration only and the scope of the claims should not be limited by these
embodiments, but
should be given the broadest interpretation consistent with the description as
a whole.
BRIEF DESCRIPTION OF DRAWINGS
[0023] The embodiments of the application will now be described in greater
detail with reference
to the attached drawings in which:
[0024] Figure 1 is a picture showing an exemplary hard molded lozenge (top
panel) and
exemplary soft chew lozenge (bottom panel).
[0025] Figure 2 shows exemplary hard molded lozenges that have been portioned
and sized
using a drop roller machine. A is a picture showing a slab of formed exemplary
hard molded
lozenges using a drop roller machine. B is a picture showing individual
exemplary hard molded
Date Recue/Date Received 2021-08-20

lozenge produced using a drop roller machine after they have been cooled,
separated and
polished using a jewelry tumbler.
[0026] Figure 3 is a graph showing the change in appropriate drop roller
manipulation
temperature of exemplary hard molded FOS lozenge compositions with varying
concentration of
glycerin, various exemplary hard molded FOS:Inulin lozenge compositions and
comparative
traditional sugar candy compositions.
[0027] Figure 4 is a graph (expressed in log scale cP) showing glycerin's
ability to reduce the
temperature dependant viscosity of exemplary hard molded lozenges comprising
fructo-
oligosaccharide or fructo-oligosaccharide and inulin as a function of glycerin
concentration.
[0028] Figure 5 is a graph showing the change in dissolution time of exemplary
hard molded
FOS lozenges with increasing concentrations of glycerin, various exemplary
hard molded
FOS:Inulin lozenges, exemplary hard molded inulin:glycerin lozenges and
comparative
traditional sugar candy formulations,
[0029] Figure 6 is a graph showing the increase in dissolution time of FOS
lozenges with
increasing amounts of inulin.
DETAILED DESCRIPTION
I. Definitions
[0030] Unless otherwise indicated, the definitions and embodiments described
in this and other
sections are intended to be applicable to all embodiments and aspects of the
present application
herein described for which they are suitable as would be understood by a
person skilled in the
art.
[0031] Terms of degree such as "substantially", "about" and "approximately" as
used herein mean
a reasonable amount of deviation of the modified term such that the end result
is not significantly
changed. These terms of degree should be construed as including a deviation of
at least 5% of
the modified term if this deviation would not negate the meaning of the word
it modifies.
[0032] As used in this application, the singular forms "a", "an" and "the"
include plural references
unless the content clearly dictates otherwise. For example, an embodiment
including "a
oligosaccharide" should be understood to present certain aspects with one
oligosaccharide or
two or more oligosaccharides.
[0033] The term "and/or" as used herein means that the listed items are
present, or used,
individually or in combination. In effect, this term means that "at least one
of" or "one or more" of
the listed items is used or present.
[0034] The term "suitable" as used herein means that the selection of the
particular compound
or conditions would depend on the specific synthetic manipulation to be
performed, and the
identity of the species to be transformed, but the selection would be well
within the skill of a
person trained in the art. All method steps described herein are to be
conducted under conditions
6
Date Recue/Date Received 2021-08-20

sufficient to provide the desired product. A person skilled in the art would
understand that all
reaction conditions, including, for example, reaction solvent, reaction time,
reaction temperature,
reaction pressure, reactant ratio and whether or not the reaction should be
performed under an
anhydrous or inert atmosphere, can be varied to optimize the yield of the
desired product and it
is within their skill to do so.
[0035] The term "subject" as used herein includes all members of the animal
kingdom including
mammals, and suitably refers to humans. Thus the methods and uses of the
present application
are applicable to both human therapy and veterinary applications.
[0036] As used herein, the term "effective amount" or "therapeutically
effective amount" means
an amount of a compound, or one or more compounds of the application that is
effective, at
dosages and for periods of time necessary to achieve the desired result.
[0037] The term "cannabinoid" as used herein refers to one of a group of
compounds that acts
on cannabinoid receptors.
[0038] The term "cannabinoid extract" as used herein refers to any extract
from a cannabis plant
comprising one or more cannabinoids.
[0039] The term "lozenge," as used herein, refers a solid or semi-solid buccal
dosage form that
is dissolvable in the mouth.
[0040] The term "hard molded lozenge" as used herein refers to a lozenge
having rigid structure
that will not deform once biting pressure is applied, and may split into
pieces once biting pressure
is sufficient to break the rigid structure.
[0041] The term "soft chew lozenge" as used herein refers to a lozenge having
a structure that
is deformable under biting pressure.
[0042] The term "buccal dosage form" used herein refers to a dosage form that
is generally
intended to be held in the mouth and used to deliver an active compound
through one or more
membranes in the buccal cavity, including the buccal mucosa, buccal gingiva,
mucous
membrane of the tongue, sublingual membrane and the soft palate. The term
encompasses all
suitable solid and semi-solid dosage forms. A buccal form may be swallowed if
so desired by a
user.
[0043] The term "polysaccharide" as used herein, refers to a saccharide
comprising two or more
monosaccharide units joined by glycosidic bonds and having various degrees of
polymerization.
The term encompasses heterogenous mixtures of polysaccharides having various
degrees of
polymerization and also encompasses polysaccharides, such as those
polysaccharides obtained
from natural sources, and which may comprise polysaccharides having various
degrees of
polymerization and may also comprise some amount of oligosaccharides and/or
heterogeneous
mixtures of oligosaccharides. As used herein, polysaccharides refers to
polysaccharides having
an average degree of polymerization of about 9 or greater.
7
Date Recue/Date Received 2021-08-20

[0044] The term "oligosaccharide" as used herein refers to a saccharide
comprising two or more
monosaccharide units joined by glycosidic bonds and having a degree of
polymerization of about
or less. The term encompasses heterogenous mixtures of oligosaccharides having
various
degrees of polymerization of about 10 or less.
[0045] The term "saccharide" refers to a carbohydrate comprising
monosaccharides,
disaccharides, oligosaccharide, and/or polysaccharides.
[0046] The term "inulin" as used herein refers to a heterogeneous mixture of
polysaccharides
having various molecular weights or degrees of polymerization. Inulin belongs
to a class of fibres
known as fructans and generally comprises fructose units with beta 1-2 bonds
which may end in
a glucose unit and generally comprises a relatively high degree of
polymerization. The term
encompasses raw inulin obtained from natural sources and fractions of inulin.
The term
encompasses inulin comprising heterogenous mixtures of polysaccharides having
various
average degrees of polymerization and also encompasses inulin which may
comprise
polysaccharides having various average degrees of polymerization and may also
comprise some
amount of naturally occurring oligosaccharides or mixtures of
oligosaccharides. !nulin as used
herein refers to inulin having an average degree of polymerization of about 9
or greater.
[0047] The term "degree of polymerization" or "DP" as used herein refers to
the number of
monosaccharide residues present in an oligo- or polysaccharide. The degree of
polymerization
is a measure of molecular weight (MW) and can be calculated as the ratio of
the total MW of the
polymer or oligomer and the MW of the repeating units.
[0048] The term "average degree of polymerization" as used herein refers to
the mean of the
degree of polymerization of all the molecules present in the oligo- or
polysaccharide. A
saccharide with a DP in a certain range may include a mixture of saccharides
with different
average DPs.
[0049] The term "fructo-oligosaccharide", "FOS" or "oligofructose" as used
herein refers to an
oligosaccharide generally comprising fructose units linked by a glycosidic
bond which may end
in a glucose unit. FOS may be obtained by partial hydrolysis or by physical
separation of inulin
obtained from plant sources or FOS may be enzymatically synthesized from
sucrose.
[0050] The term "galacto-oligosaccharide" as used herein refers to an
oligosaccharide generally
comprising galactose units linked by a glycosidic bond.
[0051] The term "glycerin" or "glycerol" or "glycerine" as used herein refers
to a compound
having the IUPAC name: propane-1,2,3-triol, and having the chemical formula
OH
HOOH
8
Date Recue/Date Received 2021-08-20

[0052] The term "% (w/w)" or "weight percent" as used herein means, unless
otherwise noted,
the ratio of the mass of one component of a composition compared to the mass
on a dry solids
basis of the entire buccal dosage form.
II. Formulations of the Application
[0053] Buccal dosage forms such as hard molded lozenge, soft chew lozenges,
and
compressed tablets comprising one or more cannabinoid and/or cannabinoid
extracts and one
or more oligosaccharides such as fructo-oligosaccharide alone or in
combination with one or
more polysaccharides such as inulin, and optionally including a plasticizer
such as glycerin have
been prepared. Buccal dosage forms comprising one or more polysaccharides such
as inulin
and a plasticizer such glycerin have also been prepared. In an embodiment, the
buccal dosage
forms have been prepared without any added sugars, sweeteners, or sweetening
agents
[0054] A challenge in manufacturing buccal dosage forms without any added
sugars,
sweeteners, or sweetening agents is to provide a buccal dosage form that
tastes and performs
comparably to a buccal dosage forms comprising sugar. Oligosaccharides such as
fructo-
oligosaccharide and polysaccharides such as inulin are not as sweet as sugar.
Oligosaccharides
such as fructo-oligosaccharide have about 30% (w/w) to 50% the sweetness of
sugar, while inulin
has only about 10% the sweetness of sugar. Further, formulations comprising a
cannabinoid
such as tetrahydrocannabinol (THC) are known to provide a bitter taste with
unpleasant "grassy"
notes, particularly in the case of lower-purity cannabinoid extracts, which
contains within it
various waxes, flavonoids, and/or other plant compounds. Surprisingly, the
Applicant has found
that the buccal dosage forms of the application comprising one or more
oligosaccharides such
as fructo-oligosaccharide alone or in combination with one or more
polysaccharides such as
inulin, and optionally including a plasticizer such as glycerin, or comprising
one or more
polysaccharides such as inulin and a plasticizer such glycerin have a
sufficiently sweet and
pleasant flavour and "mouth-feel" without any added sugars, sweeteners, or
sweetening agents.
This was true also for high potency dosage forms of the application such as
hard molded
lozenges comprising, for example, up to 10mg of THC.
[0055] The buccal dosage forms of the application have also been found to have
a dissolution
profile comparable to that of buccal dosage forms comprising sugar. Further,
the rate of
dissolution of the buccal dosage forms such as the hard molded lozenge dosage
forms can be
adjusted (e.g increased) by the addition of a plasticizer such as glycerin.
Therefore, the Applicant
has advantageously found the rate of dissolution of the hard molded lozenge
dosage can be
modulated by varying the amount of a plasticizer such as glycerin added to the
dosage form.
[0056] The addition of a plasticizer such as glycerin was also found to
advantageously decrease
the temperature of solidification of the bulk lozenge product in the
preparation of the hard molded
lozenge dosage forms thereby increasing the efficiency and workability of the
manufacturing
9
Date Recue/Date Received 2021-08-20

process. Decreasing the temperature of solidification increases the time
available to work the
bulk lozenge product to provide the individual hard molded lozenges.
[0057] Further, the addition of glycerin was found to provide a bulk lozenge
product that had
improved moldability compared to the identical bulk lozenge product but
without glycerin.
[0058] Therefore, the Applicant has surprisingly found that the buccal dosage
forms of the
application comprising one or more oligosaccharides such as fructo-
oligosaccharide alone or in
combination with one or more polysaccharides such as inulin, and optionally
including a
plasticizer such as glycerin, or buccal dosage forms comprising one or more
polysaccharides
such as inulin and a plasticizer such glycerin both provide both a satisfying
tactile or "mouth feel"
and/or a pleasant flavor experience and excellent manufacturing workability
and moldability
without added sugars, sweeteners, or sweetening agents. In an embodiment, the
addition of a
plasticizer such as glycerin to the hard molded lozenge dosage forms provides
a favourable and
controllable rate of dissolution, low resulting viscosity in solution, a
controllable temperature and
rate of solidification and improved moldability, without added sugars,
sweeteners, or sweetening
agents.
[0059] The Applicant has also unexpectedly found that the buccal forms of the
application
provide surprising advantages in reclaiming rework from the manufacturing
process of the buccal
dosage forms such as hard lozenge buccal dosage forms. Rework refers to the
scrap or unused
product from one manufacturing batch that that is subsequently used and/or
incorporated into
the next manufacturing batch. Typically, in the making of conventional hard
molded lozenges
with sugar (hard molded candy), rework is reclaimed by being ground up and
added to the next
batch or by being ground up, filtered, and put into solution using specialized
and costly rework
reclamation equipment. Generally, only about 2-5% of rework can be used in
each subsequent
batch in the first manner while about 10% of rework can be used in each
subsequent batch by
the second process. The Applicant has found that rework resulting form the
preparation of the
hard lozenge buccal dosage forms of the application can be simply and
efficiently reheated and
remolded or incorporated into a single new batch with essentially no loss of
product. Maximizing
the usability of rework without needing to distribute such rework in stages
across multiple
subsequent batches is very advantageous as it affects both quality of product
and costs. For
example, the ability to reheat and re-process rework in isolation, without
needing to mix across
subsequent batches minimizes loss, maintains active pharmaceutical ingredient
tracking,
controls input variation across lots, and mitigates cross contamination risk.
Minimizing the
amount of rework and having further control over product variability is also
particularly
advantageous when using high cost and highly regulated actives such as
cannabinoids and/or
cannabinoid extracts (e.g., cannabinoid distillates and infusions).
[0060] Further, oligosaccharides such as fructo-oligosaccharide or galacto-
oligosaccharide are
non-digestible oligosaccharides. Non-digestible oligosaccharides are known to
have many health
Date Recue/Date Received 2021-08-20

benefits. In an embodiment, the one or more non-digestible oligosaccharides is
a prebiotic and/or
a soluble fibre. Soluble fibre dissolves in ambient water and can attract
water and form a gel.
Soluble fibre can slow down digestion and delay the emptying of a stomach.
Therefore, the one
or more non-digestible oligosaccharides contributes to the dietary fibre
fraction of the diet and/or
a feeling of satiety. In an embodiment, the one or more non-digestible
oligosaccharides have a
reduced calorie content and a lower glycemic index compared to sucrose (table
sugar).
[0061] In an embodiment, the soft chew lozenge forms comprising one or more
oligosaccharides such as fructo-oligosaccharide were found to be surprisingly
stable. Without
being bound by theory, the humectant properties of the one or more
oligosaccharides help
maintain moisture levels and lower water activity thereby contributing to
restraining
microorganism development and to lengthening shelf-life.
[0062] Accordingly, the present application includes a buccal dosage form
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less.
[0063] In an embodiment, the buccal dosage form is a solid or semi-solid form.
In an
embodiment, the buccal dosage form is suitable for chewing, sucking, buccal
dissolution or
swallowing. Although intended to be held in the mouth of a subject, a person
of skill in the art
would appreciate that a subject may choose to swallow the buccal dosage form.
The choice of
chewing, sucking, buccal dissolution or swallowing may be at the discretion of
the subject. In an
embodiment, the buccal dosage form is intended to be held in the mouth of a
subject. In an
embodiment, the buccal dosage form is suitable for sucking or buccal
dissolution. In an
embodiment, the buccal dosage form dissolves in a subject's mouth by passive
incubation in the
oral cavity, or actively by sucking or mastication to deliver the one or more
cannabinoids, and/or
a cannabinoid extract to the oral cavity and esophagus. In an embodiment, the
buccal dosage
form dissolves in a subject's mouth by passive incubation in the oral cavity,
or actively by sucking
to deliver the one or more cannabinoids, and/or a cannabinoid extract to the
oral cavity and
esophagus. In an embodiment, the buccal dosage form is a sublingual dosage
form.
[0064] In an embodiment, the buccal dosage form is a lozenge. In an
embodiment, the lozenge
is a hard molded lozenge, soft chew lozenge, compressed tablet lozenge, a soft
lozenge, troche,
cachou, pill, capsule, tab, a pellet, a dragee or a pastille. In an embodiment
the lozenge is a hard
molded lozenge, compressed tablet lozenge or a soft chew lozenge. In an
embodiment the
lozenge is a hard molded lozenge or compressed tablet lozenge.. In an
embodiment the lozenge
is a hard molded lozenge.
[0065] In an embodiment, the buccal dosage form comprises about 10% (w/w) to
about 99.9%
(w/w), about 15% (w/w) to about 99.9% (w/w), about 20% (w/w) to about 99.9%
(w/w), about
25% (w/w) to about 99.9% (w/w), about 30% (w/w) to about 99.9% (w/w), about
35% (w/w) to
11
Date Recue/Date Received 2021-08-20

about 99.9% (w/w), about 40% (w/w) to about 99.9% (w/w), about 45% (w/w) to
about 99.9%
(w/w), about 50% (w/w) to about 99.9% (w/w), about 55% (w/w) to about 99.9%
(w/w), about
60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about
70% (w/w) to
about 99.9% (w/w), about 75% (w/w) to about 99.9% (w/w), about 80% (w/w) to
about 99.9%
(w/w), about 85% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 99.9%
(w/w), about
95% (w/w) to about 99.9% (w/w), about 96% (w/w) to about 99.9% (w/w), about
97% (w/w) to
about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to
about 99.9%
(w/w), about 99.5% (w/w) to about 99.9% (w/w), about 99.7% (w/w) to about
99.9% (w/w), about
99.8% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99% (w/w), about
96% (w/w) to
about 99% (w/w), about 97% (w/w) to about 99% (w/w), about 98% (w/w) to about
99% (w/w),
about 98% (w/w) to about 98.5% (w/w) or about 96% (w/w) to about 98.5% (w/w)
of the one or
more oligosaccharides. In an embodiment, the buccal dosage form comprises
about 10% (w/w)
to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to
about 95% (w/w),
about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about
25% (w/w) to
about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about
75% (w/w),
about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about
30% (w/w) to
about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 40% (w/w) to about
60% (w/w),
about 45% (w/w) to about 50% (w/w), about 20% (w/w) to about 60% (w/w), about
20% (w/w) to
about 50% (w/w), about 10% (w/w) to about 50% (w/w), or about 10% (w/w) to
about 75% (w/w)
of one or more oligosaccharides.
[0066] In an embodiment, the buccal dosage form comprises about 10% (w/w),
about 15%
(w/w), about 20% (w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w),
about 40% (w/w),
about 45% (w/w), about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70%
(w/w), about
75% (w/w), about 80% (w/w), about 85% (w/w), about 90% (w/w), about 95% (w/w),
about 96%
(w/w), about 97% (w/w), about 98% (w/w), about 99% (w/w) or about 99% (w/w) or
more of the
one or more oligosaccharides.
[0067] Accordingly, the present application includes a buccal dosage form
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 10% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less
[0068] In an embodiment, the buccal dosage form is comprised primarily of the
one or more
oligosaccharides. In an embodiment, the buccal dosage form comprises more than
about 70%
of the one or more oligosaccharides having a degree of polymerization of about
10 or less.
[0069] Accordingly, the present application also includes a buccal dosage form
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
12
Date Recue/Date Received 2021-08-20

(b) about 70% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
[0070] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or
less, about 4 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or
less. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 8 or
less, about 7 or
less, or about 6, or about 5 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 10 or less. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9 or
less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 8 or less. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 2 to about 10. In an embodiment, the one or more
oligosaccharides have
a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2
to about 7, about 2
to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about
3 to about 8, about
3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8, about
3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
3 to about 9, about
2 to about 8 or about 3 to about 8. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 9. In an embodiment, the one or
more
oligosaccharides have a degree of polymerization of about 2 to about 8. In an
embodiment, the
one or more oligosaccharides have a degree of polymerization of about 3 to
about 10. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
about 3 to about
9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 3 to
about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one
or more
oligosaccharides have a degree of polymerization of about 3 to about 9, or
about 3 to about 8.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
3 to about 9. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 3 to about 8.
[0071] In an embodiment, the one or more oligosaccharides are selected from
digestible
oligosaccharides and non-digestible oligosaccharides and combinations thereof.
[0072] In an embodiment, the one or more oligosaccharides are one or more
digestible
oligosaccharide. In an embodiment, the one or more oligosaccharides is malto-
oligosaccharide.
[0073] In an embodiment, the one or more oligosaccharides are one or non-
digestible
oligosaccharide. In an embodiment, the one or more non-digestible
oligosaccharides is a
13
Date Recue/Date Received 2021-08-20

prebiotic. In an embodiment, the one or more non-digestible oligosaccharides
is a soluble fibre.
Soluble fibre dissolves in ambient water and can attract water and form a gel.
Soluble fibre can
slow down digestion and delay the emptying of a stomach. Therefore, in an
embodiment, the one
or more non-digestible oligosaccharides contributes to the dietary fibre
fraction of the diet and/or
a feeling of satiety. In an embodiment, the one or more non-digestible
oligosaccharides have a
reduced calorie content and a lower glycemic index compared to sucrose (table
sugar).
[0074] In an embodiment, the one or more oligosaccharides are selected from
one or more
oligosaccharides comprising one type of sugar monomer, and one or more
oligosaccharide
comprising one two or more different types of sugar monomers and combinations
thereof.
[0075] In an embodiment, the one or more non-digestible oligosaccharides are
selected from
fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), gluco-
oligosaccharides
arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-
oligosaccharides (IMO), raffinose family of oligosaccharides (RFO), gluco-
galacto-
oligosaccharides, gluco-fructo-oligosaccharides, gluco-manno-oligosaccharides,
gluco-arabino-
oligosaccharides, gluco-xylo-oligosaccharides, galacto-fructo-
oligosaccharides, galacto-manno-
oligosaccharides, galacto-arabino-oligosaccharides, galacto-xylo-
oligosaccharides, fructo-
manno-oligosaccharides, fructo-arabino-oligosaccharides, fructo-xylo-
oligosaccharides, manno-
arabino-oligosaccharides, manno-xylo-oligosaccharides, and arabino-xylo-
oligosaccharides,
and combinations thereof. In an embodiment, the one or more non-digestible
oligosaccharides
are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides
(GOS), arabino-
oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-
oligosaccharides
(IMO), and raffinose family of oligosaccharides, and combinations thereof. In
an embodiment,
the one or more non-digestible oligosaccharides are selected from fructo-
oligosaccharides
(FOS), and galacto-oligosaccharides (GOS) and combinations thereof. In an
embodiment, the
one or more non-digestible oligosaccharides is fructo-oligosaccharides (FOS).
[0076] In an embodiment, the galacto-oligosaccharides are selected from
transgalacto-
oligosaccharides (TGOS) and beta-galacto-oligosaccharides, and combinations
thereof.
[0077] The one or more oligosaccharides are commercially available or can be
prepared by
methods known in the art. For example, in an embodiment, fructo-
oligosaccharides (FOS) are
produced by the partial enzymatic hydrolysis from inulin from natural sources
such as from
chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana, or agave
or the FOS is
produced by the partial enzymatic hydrolysis from chicory inulin. In an
embodiment, FOS is
prepared by enzymatic synthesis with sucrose by methods known in the art, for
example, by the
transfructosylation of sucrose by p-fructofuranosidases. In an embodiment,
fructo-
oligosaccharides (FOS) are commercially available under the tradenames Orafti@
Oligofructose
from Beneo GmbH New Jersey, U.S.A) and Fossence @ by Tata NQ (Maharashtra,
India),
galacto-oligosaccharides are commercially available under the tradenames Ariya
Purity GOS
14
Date Recue/Date Received 2021-08-20

by Ariya Health (Queensland, Australia) and isomalto-oligosaccharides are
commercially
available under the tradename IMO Fibre by Nutra Food ingredients (Michegan,
USA). In an
embodiment, the FOS is Orafti@ Oligofructose from Beneo GmbH New Jersey,
U.S.A. In an
embodiment, the FOS is Orafti@ P95 Oligofructose from Beneo GmbH New Jersey,
U.S.A.
[0078] The Applicant's have found that the buccal dosage forms of the
application comprising
one or more oligosaccharides alone or in combination with one or more
polysaccharides such
as inulin, and optionally including a plasticizer such as glycerin, or buccal
dosage forms
comprising one or more polysaccharides such as inulin and a plasticizer such
glycerin provide a
satisfying tactile or "mouth feel" and/or a pleasant flavor experience without
added sugars,
sweeteners, or sweetening agents.
[0079] Accordingly, in an embodiment, the buccal dosage forms of the present
application are
free of added sugars, sweeteners, and/or sweetening agents.
[0080] It would be appreciated by a person skilled in the art that the one or
more
oligosaccharides having a degree of polymerization (DP) of, for example, about
10 or less
comprise a heterogenous mixture of oligosaccharides of different DPs. For
example, in a
embodiment, when the one or more oligosaccharides having a DP of, for example,
about 10 or
less is fructo-oligosaccharide, the fructo-oligosaccharide having a DP of
about 10 or less
comprises a heterogenous mixture of oligosaccharides of different DPs of about
10 or less
including, for example, kestose, nystose, fructosylnystose, bifurcose,
inulobiose (two D-fructose
residues linked together or fructo-oligosaccharide having a DP of 2),
inulotriose (three D-fructose
residues linked together or fructo-oligosaccharide having a DP of 3), and
inulotetraose (four D-
fructose residues linked together or fructo-oligosaccharide having a DP of 4).
[0081] It would also be appreciated by a person skilled in the art of, that
the one or more
oligosaccharides having a DP of about 10 or less also comprise sugars (i.e.,
monosaccharides
and/or disaccharides) as natural components of the one or more
oligosaccharides having a DP
of about 10 or less. Accordingly, in an embodiment, the one or more
oligosaccharides having a
DP of, for example, about 10 or less comprise naturally occurring sugars
(i.e., monosaccharides
and/or disaccharides). In an embodiment, the one or more oligosaccharides
having a DP of, for
example, about 10 or less comprise naturally occurring monosaccharides and/or
disaccharides
resulting, for example, from the isolation or manufacturing process of the one
or more
oligosaccharides. In an embodiment, the one or more oligosaccharides comprise
about 45%
(w/w) or less, about 40%(w/w) or less, about 30%(w/w) or less, about 20%(w/w)
or less, about
15% (w/w) or less, about 10% (w/w) or less, about 9%(w/w) or less, about
8%(w/w) or less, about
7%(w/w) or less, about 6%(w/w) or less, about 5%(w/w) or less, about 4%(w/w)
or less, about
3%(w/w), about 2%(w/w) or less, or about 1%(w/w) or less of the
monosaccharides and/or
disaccharides on a dry solid basis of the total weight of the one or more
oligosaccharides. In an
embodiment, the one or more oligosaccharides comprise about 15% (w/w) or less,
about 10%
Date Recue/Date Received 2021-08-20

(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or
less, about
6%(w/w) or less, about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w)
or less, about
2%(w/w) or less, or about 1%(w/w) or less of monosaccharides and/or
disaccharides on a dry
solid basis of the total weight of the one or more oligosaccharides. In an
embodiment, the one or
more oligosaccharides comprise about 40% (w/w) or less, about 30%(w/w) or
less, about 15%
(w/w) or less, about 10% (w/w) or less, about 8%(w/w) or less, about 5%(w/w)
or less, about
3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) of monosaccharides
and/or
disaccharides on a dry solid basis of the total weight of the one or more
oligosaccharides. In an
embodiment, the one or more oligosaccharides comprise about 5%(w/w) or less of
monosaccharides and/or disaccharides on a dry solid basis of the total weight
of the one or more
oligosaccharides. In an embodiment, the one or more oligosaccharides comprise
about 0.1 %
(w/w) to about 40 % (w/w), about 0.1 % (w/w) to about 35 % (w/w), about 0.1 %
(w/w) to about
30 % (w/w), about 0.1 % (w/w) to about 25 % (w/w), about 0.1 % (w/w) to about
20 % (w/w),
about 1 % (w/w) to about 40 % (w/w), about 1 % (w/w) to about 35 % (w/w),
about 1 % (w/w) to
about 30 % (w/w), about 1 % (w/w) to about 25 % (w/w), about 1 % (w/w) to
about 20 % (w/w),
about 3 % (w/w) to about 40 % (w/w), about 3 % (w/w) to about 35 % (w/w),
about 3% (w/w) to
about 30 % (w/w), about 3 % (w/w) to about 25 % (w/w), about 3 % (w/w) to
about 20 % (w/w),
about 0.1 % (w/w) to about 15% (w/w), about 0.25 % (w/w) to about 15% (w/w),
about 1% (w/w)
to about 15% (w/w), about 0.1 % (w/w) to about 8% (w/w), about 0.25 % (w/w) to
about 8%
(w/w), about 1% (w/w) to about 8% (w/w), about 0.1 % (w/w) to about 10% (w/w),
about 0.25 %
(w/w) to about 10% (w/w), about 1% (w/w) to about 10% (w/w), about 0.1 % (w/w)
to about 5%
(w/w), about 0.25 % (w/w) to about 5% (w/w), about 1% (w/w) to about 5% (w/w),
about 0.1 %
(w/w) to about 3% (w/w), about 0.25 % (w/w) to about 3% (w/w), about 1% (w/w)
to about 3%
(w/w), about 0.1 % (w/w) to about 2% (w/w), about 0.25 % (w/w) to about 2%
(w/w), about 1%
(w/w) to about 2% (w/w) of the monosaccharides and/or disaccharides on a dry
solid basis of
the total weight of the one or more oligosaccharides. In an embodiment, the
one or more
oligosaccharides comprise about 0.1 % (w/w) to about 10% (w/w), about 0.25 %
(w/w) to about
10% (w/w), about 1% (w/w) to about 10% (w/w), about 0.1 % (w/w) to about 5%
(w/w), about
0.25 % (w/w) to about 5% (w/w), about 1% (w/w) to about 5% (w/w), about 0.1 %
(w/w) to about
3% (w/w), about 0.25 % (w/w) to about 3% (w/w), about 1% (w/w) to about 3%
(w/w), about 0.1
% (w/w) to about 2% (w/w), about 0.25 % (w/w) to about 2% (w/w), about 1%
(w/w) to about 2%
(w/w) of the monosaccharides and/or disaccharides on a dry solid basis of the
total weight of the
one or more oligosaccharides. In an embodiment, the one or more
oligosaccharides comprise
about 1% (w/w) to about 10% (w/w), about 1% (w/w) to about 8% (w/w), or about
1 % (w/w) to
about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of
the total weight
of the one or more oligosaccharides.
[0082] As described above, fructo-oligosaccharide having a DP of about 10 or
less comprises
a heterogenous mixture of oligosaccharides of different DPs including, for
example, kestose,
16
Date Recue/Date Received 2021-08-20

nystose, fructosylnystose, bifurcose, inulotriose, inulotetraose and
inulobiose. Inulobiose is
composed of two D-fructose residues linked together (i.e., fructo-
oligosaccharide having a DP of
2) and is a disaccharide. Therefore, inulobiose is both a sugar (i.e.,
disaccharide) and an
oligosaccharide (i.e., fructo-oligosaccharide of DP of 2) and can be
categorized as either a sugar
or an oligosaccharide. The inconsistency in the categorization of inulobiose
would be appreciated
by a person skilled in the art, see for example, Cummings, J., Stephen, A.
Carbohydrate
terminology and classification. Eur J Clin Nutr61, S5¨S18 (2007), and Marcel
B. Roberfroid,
Inulin-Type Fructans: Functional Food Ingredients, The Journal of Nutrition,
Volume 137, Issue
11, November 2007, Pages 2493S-2502S. Also, regulatory agencies, including but
not limited
to, the Food and Drug Administration, Health Canada or European Medicines
Agency, and
manufacturers of fructo-oligosaccharides, for example, OraftiO Oligofructose
as provided from
Beneo GmbH New Jersey, U.S.A define inulobiose as either a fibre (i.e.,
oligosaccharide) or a
sugar. For example, Health Canada considers a dietary fibre to consist of, for
example,
carbohydrates with a DP of 3 or more that naturally occur in foods of plant
origin and that are not
digested and absorbed by the small intestine, the Australian food agency
considers the term
dietary fibre to comprise, for example, oligosaccharides with a DP of greater
than 2, while
manufacturers of oligosaccharides such as Beneo GmbH New Jersey (OraftiO
Oligofructose)
generally define inulobiose as a dietary fiber (e.g. oligosaccharide) and make
note that regulatory
agencies may require inulobiose to be considered a sugar.
[0083] For the purposes of this application, fructo-oligosaccharide comprising
a DP of 2, for
example, as in a DP of about 2 to about 10 or less, is considered to include
inulobiose as a
naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide
is fructo-
oligosaccharide having a DP of 2). Therefore, when inulobiose is considered to
be an
oligosaccharide, fructo-oligosaccharide having a DP of, for example, 10 or
less (such as about 2
to about 10, about 2 to about 9 or about 2 to about 8) which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
wherein the
inulobiose occurring as a natural component of the fructo-oligosaccharide is
an oligosaccharide
having a DP of 2. Further, when inulobiose is considered to be
oligosaccharide, fructo-
oligosaccharide having a DP of, for example, 10 or less which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
(such as about
2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a
heterogenous mixture
of oligosaccharides of different DPs of about 2 to about 10 or less including
inulobiose and
comprises naturally occurring sugars (i.e., monosaccharides and/or
disaccharides) not including
inulobiose.
[0084] It would be appreciated by a person skilled in the art, that when
inulobiose is considered
to be a sugar, then the same fructo-oligosaccharide having a DP of, for
example, 10 or less which
comprises inulobiose as a natural component described above is fructo-
oligosaccharide having
a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to
about 9 or about 3
17
Date Recue/Date Received 2021-08-20

to about 8) wherein the inulobiose occurring as a natural component of the
fructo-oligosaccharide
is included as a component of the naturally occurring sugars in the fructo-
oligosaccharide.
Accordingly, when inulobiose is considered to be a sugar, then fructo-
oligosaccharide having a
DP of, for example, 10 or less comprising inulobiose as a natural component is
fructo-
oligosaccharide having a DP of about 3 to about 10 or less which comprises a
heterogenous
mixture of oligosaccharides of different DPs of about 3 to about 10 or less
not including inulobiose
and comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) including
inulobiose.
[0085] In an embodiment, the fructo-oligosaccharide having a DP of, for
example, 10 or less
comprising inulobiose as a natural component comprises about 0.1 % (w/w) to
about 8% (w/w),
about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 %
(w/w) to about
7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7%
(w/w), about 0.1
% (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 %
(w/w) to about 6%
(w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5%
(w/w), about 1 %
(w/w) to about 5% (w/w), about 0.1 % (w/w) to about 4% (w/w), about 0.5 %
(w/w) to about 4%
(w/w), about 1 % (w/w) to about 4% (w/w), about 0.5 % (w/w) to about 3% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an
embodiment, the fructo-oligosaccharide having a DP of, for example, 10 or less
comprising
inulobiose as a natural component comprises 0.1 % (w/w) to about 4% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide.
[0086] In an embodiment, when inulobiose is defined as a fibre, the fructo-
oligosaccharide
having a DP of, for example, about 10 or less or, for example, a DP of about 2
to about 10 or
less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8),
comprises about 1%
(w/w) to about 8% (w/w) or about 1% (w/w) to about 5% (w/w) of monosaccharides
and/or
disaccharides on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an
embodiment, when inulobiose is defined as a sugar, the fructo-oligosaccharide
having a DP of,
for example, about 10 or less or, for example, a DP of about 3 to about 10 or
less (such as about
3 to about 10, about 3 to about 9 or about 3 to about 8), comprises about 1%
(w/w) to about 8%
(w/w) or 1% (w/w) to about 10% (w/w) of monosaccharides and/or disaccharides
on a dry solid
basis of the total weight of the fructo-oligosaccharide.
[0087] Accordingly, in the context of the present application, "free of added
sugars, sweeteners
and/or sweetening agents" and the like means that the buccal dosage form does
not comprise
sugars, sweeteners and/or sweetening agents that are added in addition to the
one or more
oligosaccharides and any monosaccharides and/or disaccharides that may be
naturally present
in the one or more oligosaccharides as described above or in addition to any
monosaccharides
and/or disaccharides that may be naturally present in any other additive in
the buccal dosage
18
Date Recue/Date Received 2021-08-20

form, including but not limited to, polysaccharides, emulsifying agents, oils
and/or fats, gelling
agents, lubricants, plasticizers, flavouring agents or pH modifying agents as
described below,
and those naturally present monosaccharides and/or disaccharides are present
at levels that are
not above the naturally occurring level for each of the additives.
[0088] In an embodiment, the sugars, sweeteners and sweetening agents are
sugars,
sweeteners and sweetening agents as defined in section B.01.001 (1) of the
Food and Drug
Regulations C.R.C., c. 870 (2020)., In an embodiment, the sugars are selected
from
monosaccharides and disaccharides and combinations thereof. In an embodiment,
the
monosaccharides and disaccharides are selected from glucose, fructose,
sucrose, galactose,
ribose, lactose, and maltose and combinations thereof.
[0089] In an embodiment, the disaccharide is inulobiose. Accordingly, in an
embodiment, the
buccal dosage form does not comprise inulobiose that is added in addition to
the inulobiose
occurring as a natural component in the fructo-oligosaccharide as described
above.
[0090] In an embodiment, section B.01.001 (1) of the Food and Drug Regulations
C.R.C., c.
870 (2020) defines sweetener as any sweetener referred to in section 2 of the
Marketing
Authorization for Food Additives That May Be Used as Sweeteners (SOR/2012-
210). Section 2
of the Marketing Authorization for Food Additives That May Be Used as
Sweeteners (SOR/2012-
210) refers to sweeteners as defined in the List of Permitted Sweeteners
published by the
Department of Health of Canada. Therefore, in an embodiment, the sweeteners
are sweeteners
as referred to section 2 of the Marketing Authorization for Food Additives
That May Be Used as
Sweeteners (SOR/2012-210) and defined in column 1 of the List of Permitted
Sweeteners
published by the Department of Health of Canada. Accordingly, the sweeteners
are selected from
aspartame, ascesulfame potassium, advantame, erythritol, saccharin, including
calcium
saccharin, potassium saccharin, sodium saccharin, hydrogenated starch
hydrolysates, isomalt,
lactitol, maltitol, maltitol syrup, mannitol, monk fruit extract, neotame,
sorbitol, sorbitol syrup,
stevia, steviosides, steviol glycosides from Stevia rebaudiana Berton',
steviol glycosides from
Saccharomyces cerevisiae CD15380, steviol glycosides from Saccharomyces
cerevisiae
CD15407, sucralose, thaumatin, and xylitol, and combinations thereof.
[0091] In an embodiment, section B.01.001 (1) of the Food and Drug Regulations
C.R.C., c.
870 (2020) defines sweetening agent as any food for which a standard is
provided in Division 18
of the Food and Drug Regulations C.R.C., c. 870 (2020) but not including those
food additives
listed in the tables to Division 16 of the Food and Drug Regulations C.R.C.,
c. 870 (2020). In an
embodiment, the sweetening agent is selected from any food for which a
standard is provided in
Division 18 of the Food and Drug Regulations C.R.C., c. 870 (2020) but not
including those food
additives listed in the tables to Division 16 of the Food and Drug Regulations
C.R.C., c. 870
(2020). Accordingly, in an embodiment, the sweetening agent is selected from
table sugar, liquid
sugar, invert sugar, liquid invert sugar, icing sugar, brown sugar, yellow
sugar, golden sugar,
19
Date Recue/Date Received 2021-08-20

refined sugar syrup, refiners' syrup, golden syrup, fancy molasses, table
molasses, refiners'
molasses, blackstrap molasses, cooking molasses, dextrose anhydrous, dextrose
monohydrate,
glucose, glucose syrup, glucose solids, dried glucose syrup, syrup, lactose,
and honey and
combinations thereof.
[0092] In an embodiment, the cannabinoid extract is a crude or purified
extract from a cannabis
plant. In an embodiment, the cannabinoid extract is obtained from a cannabis
plant by
supercritical CO2 extraction, subcritical CO2 extraction, or organic solvent
extraction such as
hydrocarbon extraction or ethanol extraction, and water extraction.
[0093] In an embodiment, the cannabinoid extract is obtained from a cannabis
plant without
solvent such as by using a mechanic press, a hydraulic separator, or a sieve.
In an embodiment,
the cannabinoid extract is a dry sift.
[0094] In an embodiment, the cannabinoid extract is isolated trichomes. In an
embodiment, the
cannabinoid extract is selected from kief, hash such as drysift hash or bubble
hash, butane, hash
oil, shatter, budder, honeycomb, crumble, sap, RSO (Rick Simpson Oil), rosin,
and resin and
combinations thereof.
[0095] In an embodiment, the cannabinoid extract obtained from a cannabis
plant is purified. In
an embodiment, the cannabinoid extract is purified by dewaxing. In an
embodiment, the
cannabinoid extract is purified by fractional distillation. Accordingly, in an
embodiment, the
cannabinoid extract is a cannabinoid distillate. In an embodiment, the
cannabinoid distillate is the
product of short path distillation, spinning band distillation, wiped film
distillation, or falling film
distillation.
[0096] In an embodiment, the cannabinoid extract is purified by chromatography
and solvent
crystallization. In an embodiment, the chromatography is centrifugal partition
chromatography.
[0097] In an embodiment, the cannabinoid extract is purified such that one or
more cannabinoid
is present at greater than 60% (w/w), greater than 70% (w/w), greater than 80%
(w/w), greater
than 85% or greater than 95% of the total extract (w/w). In an embodiment, the
cannabinoid
extract is purified such that one or more cannabinoid is present greater than
85% or greater than
95% of the total extract (w/w). In an embodiment, the cannabinoid extract is
purified such that
one or more cannabinoid is present at greater than 95% of the total extract
(w/w). In an
embodiment, the cannabinoid extract is purified such that one or more
cannabinoid is present at
greater than 98% of the total extract (w/w).
[0098] In an embodiment, the one or more cannabinoids are selected from one of
more of
cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD),
cannabidiolic acid
(CBDA), cannabidivarin (CBDV), cannabidivarinic acid (CBDVA), cannabigerol
(CBG),
cannabigerol acid (CBGA), cannabigerol propyl variant (CBGV), cannabicyclol
(CBL), cannabinol
(CBN), cannabinol propyl variant (CBNV), cannabitriol (CBT), cannabichromenic
acid (CBCA),
Date Recue/Date Received 2021-08-20

cannabidiphorol (CBDP), cannabidiphorolic acid (CBDPA), tetrahydrocannabinol
(THC),
tetrahydrocannabinolic acid (THCA), tetrahydrocannabipgorolic acid (TPCPA),
tetrahydrocannabivarin (THCV), tetrahydrocannabiphorol (THCP) and
tetrahydrocannabivarinic
acid (THCVA), and combinations thereof. In an embodiment, the one or more
cannabinoids is
selected from THC and CBD and combinations thereof. In an embodiment, the one
or more
cannabinoids is THC.
[0099] In an embodiment, the one or more cannabinoids are synthetic. In an
embodiment, the
one or more cannabinoids are obtained through biofermentation methods or other
biogenerating
methods. In an embodiment, the biofermentation method is a yeast
biofermentation method.
[00100] Accordingly, the present application includes a buccal dosage form
comprising one or
more cannabinoids, and/or a cannabinoid extract as described above. In an
embodiment, the
present application includes a buccal dosage form comprising one or more
cannabinoids as
described above. In an embodiment, the present application includes a buccal
dosage form
comprising one or more cannabinoid extracts as described above. In an
embodiment, the one or
more cannabinoid extracts is a cannabinoid distillate. In an embodiment, the
one or more
cannabinoids is selected from THC and CBD and combinations. In an embodiment,
the one or
more cannabinoids is THC.
[00101] In an embodiment, the buccal dosage form of the application can be
used to administer
any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoids
in the
cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about
0.1 mg to about
500 mg, about 0.1mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1
mg to about
250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1
mg to about 50
mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to
about 5 mg,
about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment,
the one or
more cannabinoids and/or cannabinoid extract is or comprises THC and typical
doses of THC
may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20
mg, about 0.1 mg
to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg. In an
embodiment, the one
or more cannabinoids and/or cannabinoid extract is or comprises THC and
typical doses of THC
may be in the range of about 0.1 mg to about 10 mg. In an embodiment, the one
or more
cannabinoids and/or cannabinoid extract is or comprises THC and typical doses
of THC may be
about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1mg, about 0.5 mg or
about 0.1mg.
In an embodiment, the one or more cannabinoids and/or cannabinoid extract is
or comprises
THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or
about 0.1mg.
[00102] In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is or
comprises CBD and typical doses of CBD may be in the range of about 0.1 mg to
about 500 mg,
21
Date Recue/Date Received 2021-08-20

about 0.1mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to
about 250 mg,
about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to
about 50 mg,
about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to
about 5 mg, about
0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the
one or more
cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses
of CBD may be
in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1
mg.
[00103] In an embodiment the buccal dosage form comprises more than one
cannabinoid and/or
cannabinoid extract and the buccal dosage form comprises a combination of the
suitable doses
of each of the cannabinoid and/or cannabinoid extract. In an embodiment the
buccal dosage form
comprises THC and CBD, and the buccal dosage form comprises a combination of
the suitable
doses of THC and CDB. In an embodiment, the buccal dosage form comprises 10mg
of THC
and 2mg of CBD. In an embodiment, the buccal dosage form comprises equal
amounts of THC
and CBD. In an embodiment, the buccal dosage form comprises 5mg of THC and 5mg
of CBD.
In an embodiment, the buccal dosage form comprises 2.5mg of THC and 2.5mg of
CBD.
[00104] In an embodiment, the buccal dosage form comprises 0.1% (w/w) to about
3% (w/w),
about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one
or more
cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
buccal dosage
comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or
0.1% (w/w) to
about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
m105] In an embodiment, the cannabinoid extract is purified such that one or
more cannabinoid
is present at greater than about 80% (w/w), greater than about 85% or greater
than about 95%
of the total extract (w/w). In an embodiment, the buccal dosage form comprises
about 0.1% (w/w)
to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about
1% (w/w) of a
cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to
about 20 mg, about
0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5
mg, about 0.1 mg
to about 2.5 mg, about 0.1 mg to about 2 mg, or about.1 mg to about 1 mg of
THC. In an
embodiment, the cannabinoid extract comprises about 0.1 mg to about 10 mg of
THC. In an
embodiment, the buccal dosage form comprises about 0.1% (w/w) to about 2%
(w/w), or about
0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid
extract comprises
about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1mg, about 0.5 mg or
about 0.1mg of
THC.
[Ow 06] As the Applicant has prepared a hard molded lozenge comprising about
1% (w/w) of a
cannabinoid extract that comprises about 10mg of THC, the Applicant has
prepared a high
potency buccal dosage form. Therefore, in an embodiment, the buccal dosage
form is a high
22
Date Recue/Date Received 2021-08-20

potency buccal dosage form. Accordingly, in an embodiment, the present
application includes
high potency buccal dosage forms.
[00107] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:900 to about 1:5, about 1:800 to about 1:5, about 1:700 to about 1:5, about
1:600 to about 1:5,
about 1:500 to about 1:5, about 1:400 to about 1:5, about 1:300 to about 1:5,
about 1:200 to
about 1:5, about 1:150 to about 1:5, about 1:100 to about 1:5, about 1:50 to
about 1:5, of the
one or more cannabinoids, and/or a cannabinoid extract to the one or more
oligosaccharides.
[00108] In an embodiment, the buccal dosage form optionally further comprises
one or more
polysaccharides. In an embodiment, the one or more polysaccharides have a
degree of
polymerization of up to about 80 and have an average degree of polymerization
of about 9 or
greater. In an embodiment, when present the added % (w/w) of the one or more
polysaccharides
replaces an equal % (w/w) of the one or more oligosaccharides in the buccal
dosage form. By
"replaces an equal % (w/w) of the one or more oligosaccharides" it is meant
that the combined
amount of the one or more oligosaccharides and the one or more polysaccharides
in the buccal
dosage form is the same as the total amount of the one or more
oligosaccharides in an otherwise
identical buccal dosage form except for the absence one or more the one or
more
polysaccharides.
[00109] It would be appreciated by a person skilled in the art that the one or
more
polysaccharides having a degree of polymerization of up to about 80 and having
an average
degree of polymerization of about 9 or greater may comprise a heterogenous
mixture of
polysaccharides having various degrees of polymerization up to about 80 and
having an average
degree of polymerization of about 9 or greater. It would also be appreciated
by a person skilled
in the art that the one or more polysaccharides may also comprise
oligosaccharides or a mixture
of oligosaccharides. In an embodiment, the oligosaccharides or mixture of
oligosaccharides are
naturally occurring in the one or more polysaccharides, and for example,
result from the isolation
or manufacturing process.
[00110] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
[00111] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00112] In an embodiment, the buccal dosage form comprises about 0.1% (w/w) to
about 89.9%
(w/w), about 0.5% (w/w) to about 89.9% (w/w), about 1% (w/w) to about 89.9%
(w/w), about 5%
(w/w) to about 89.9% (w/w), about 10% (w/w) to about 89.9%(w/w), about 15%
(w/w) to about
23
Date Recue/Date Received 2021-08-20

89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about
89.9%(w/w),
about 30% (w/w) to about 89.9% (w/w), about 35% (w/w) to about 89.9% (w/w),
about 40% (w/w)
to about 89.9%(w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w) to
about 89.9%
(w/w), about 55% (w/w) to about 89.9%(w/w), about 60% (w/w) to about 89.9%
(w/w), about 65%
(w/w) to about 89.9% (w/w), about 70% (w/w) to about 89.9%(w/w), about 75%
(w/w) to about
89.9% (w/w), about 80% (w/w) to about 89.9% (w/w), or about 85% (w/w) to about
89.9% (w/w)
of the one or more polysaccharides.
[00113] In an embodiment, the buccal dosage form comprises about 0.1% (w/w) to
about 80%
(w/w), about 0.1% (w/w) to about 75% (w/w), about 0.5% (w/w) to about 80%
(w/w), about 1%
(w/w) to about 80% (w/w), about 5% (w/w) to about 80% (w/w), about 10% (w/w)
to about
80%(w/w), about 15% (w/w) to about 80% (w/w), about 20% (w/w) to about 80%
(w/w), about
25% (w/w) to about 80%(w/w), about 30% (w/w) to about 80% (w/w), about 35%
(w/w) to about
80% (w/w), about 40% (w/w) to about 80%(w/w), about 45% (w/w) to about 80%
(w/w), about
50% (w/w) to about 80% (w/w), about 55% (w/w) to about 80%(w/w), about 60%
(w/w) to about
80% (w/w), about 65% (w/w) to about 80% (w/w), about 70% (w/w) to about
80%(w/w), or about
75% (w/w) to about 80% (w/w) of the one or more polysaccharides.
[00114] In an embodiment, the buccal dosage form comprises about 0.1 % (w/w)
to about 88 %
(w/w), about 0.5% (w/w) to about 88% (w/w), about 1% (w/w) to about 88% (w/w),
about 5%
(w/w) to about 88% (w/w), about 10% (w/w) to about 88%(w/w), about 15% (w/w)
to about 88%
(w/w), about 20% (w/w) to about 88% (w/w), about 25% (w/w) to about 88%(w/w),
about 30%
(w/w) to about 88% (w/w), about 35% (w/w) to about 88% (w/w), about 40% (w/w)
to about
88%(w/w), about 45% (w/w) to about 88% (w/w), about 50% (w/w) to about 88%
(w/w), about
55% (w/w) to about 88%(w/w), about 60% (w/w) to about 88% (w/w), about 65%
(w/w) to about
88% (w/w), about 70% (w/w) to about 88%(w/w), about 75% (w/w) to about 88%
(w/w), about
80% (w/w) to about 88% (w/w), or about 85% (w/w) to about 88% (w/w) of the one
or more
polysaccharides.
[00115] In an embodiment, when one or more polysaccharides are present, the
buccal dosage
form comprises about 0.1% (w/w) to about 89.9% (w/w), about 0.5% (w/w) to
about 89.9% (w/w),
about 1% (w/w) to about 89.9% (w/w), about 5% (w/w) to about 89.9% (w/w),
about 10% (w/w)
to about 89.9%(w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to
about 89.9%
(w/w), about 25% (w/w) to about 89.9%(w/w), about 30% (w/w) to about 89.9%
(w/w), about 35%
(w/w) to about 89.9% (w/w), about 40% (w/w) to about 89.9%(w/w), about 45%
(w/w) to about
89.9% (w/w), about 50% (w/w) to about 89.9% (w/w), about 55% (w/w) to about
89.9%(w/w),
about 60% (w/w) to about 89.9% (w/w), about 65% (w/w) to about 89.9% (w/w),
about 70% (w/w)
to about 89.9%(w/w), about 75% (w/w) to about 89.9% (w/w), about 80% (w/w) to
about 89.9%
(w/w) or about 85% (w/w) to about 89.9% (w/w) of one or more polysaccharides.
In an
embodiment, the buccal dosage form comprises about 0.1% (w/w) to about 88.9%
(w/w), about
0.1% (w/w) to about 80% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1%
(w/w) to about
24
Date Recue/Date Received 2021-08-20

50% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70%
(w/w), about
5% (w/w) to about 50% (w/w), about 10% (w/w) to about 70%(w/w), about 15%
(w/w) to about
60% (w/w), about 20% (w/w) to about 75% (w/w), about 25% (w/w) to about
75%(w/w), 0.1%
(w/w) to about 74% (w/w), about 40% (w/w) to about 70% (w/w), about 10% (w/w)
to about
30%(w/w), about 15% (w/w) to about 25% (w/w), about 50% (w/w) to about 75%
(w/w), about
50% (w/w) to about 74% (w/w), about 25% (w/w) to about 85% (w/w), about 25%
(w/w) to about
80% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50%
(w/w), about
30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), 40% (w/w) to
about 60%
(w/w), about 45% (w/w) to about 55% (w/w), about 45% (w/w) to about 50% (w/w),
about 20%
(w/w) to about 60% (w/w), about 20% (w/w) to about 50% (w/w), about 10% (w/w)
to about 50%
(w/w), or about 10% (w/w) to about 75% (w/w) of one or more of one or more
polysaccharides.
[00116] In an embodiment, when one or more polysaccharides are present, the
buccal dosage
form comprises about 70% (w/w) to about 97.9% (w/w), about 75% (w/w) to about
97.9% (w/w),
about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w),
about 95% (w/w)
to about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w), about 97% (w/w) to
about 97.9%
(w/w) of one or more oligosaccharides.
[00117] In an embodiment, when one or more polysaccharides are present the
buccal dosage
form comprises about 10% (w/w) to about 89.9% (w/w), about 15% (w/w) to about
89.9% (w/w),
about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about 89.9% (w/w),
about 30% (w/w)
to about 89.9% (w/w), about 40 (w/w) to about 89.9% (w/w), about 45% (w/w) to
about 89.9%
(w/w), about 50% (w/w) to about 89.9% (w/w), about 55% (w/w) to about 89.9%
(w/w), about
65% (w/w) to about 89.9% (w/w), about 70% (w/w) to about 89.9% (w/w), about
75% (w/w) to
about 89.9% (w/w), about 80% (w/w) to about 89.9% (w/w), about 85% (w/w) to
about 89.9%
(w/w), about 45% (w/w) to about 80% (w/w), about 50% (w/w) to about 80% (w/w),
or about 55%
(w/w) to about 80% (w/w) of one or more oligosaccharides.
[00118] In an embodiment, when one or more polysaccharides are present the
buccal dosage
form comprises about 1% (w/w), about 5% (w/w), about 10% (w/w), about 15%
(w/w), about 20%
(w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w),
about 45% (w/w),
about 50% (w/w), about 55% (w/w), about 60% (w/w), about 65% (w/w), about 70%
(w/w), about
75% (w/w), about 80% (w/w), about 85% (w/w), or about 89% (w/w) of one or more
polysaccharides.
[00119] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 99.9 % (w/w) of the
buccal
dosage form.
[00120] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 60% (w/w) to about 99.9% (w/w), about
65% (w/w) to
about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to
about 99.9%
Date Recue/Date Received 2021-08-20

(w/w), about 80% (w/w) to about 99.9% (w/w), about 85% (w/w) to about 99.9%
(w/w), about
90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about
97% (w/w) to
about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to
about 99.9%
(w/w), about 99.5% (w/w) to about 99.9% (w/w) .
[00121] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 89.9% (w/w) to about 98% (w/w), about
95% (w/w) to
about 98% (w/w), about 97% (w/w) to about 98% (w/w), or about 98% (w/w) to
about 98% (w/w)
of the buccal dosage form. In an embodiment, the one or more oligosaccharides
and the one or
more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w),
about 60%
(w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w)
to about 90%
(w/w), about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w),
or about 85%
(w/w) to about 90% (w/w), about 90% (w/w) to about 98% (w/w), about 90% (w/w)
to about 97%
(w/w), about 90% (w/w) to about 96% (w/w) or about 90% (w/w) to about 95%
(w/w) of the total
weight of the buccal dosage form. In an embodiment, the one or more
oligosaccharides and the
one or more polysaccharides combined comprise about 60% (w/w) to about 80%
(w/w), about
60% (w/w) to about 70% (w/w), about 90% (w/w) to about 98% (w/w), about 90%
(w/w) to about
97% (w/w), about 90% (w/w) to about 96% (w/w) or about 90% (w/w) to about 95%
(w/w) of the
total weight of the buccal dosage form.
[00122] In an embodiment, the one or more polysaccharides are selected from
modified
starches, maltodextrin, polydextrose, fructans, glucans, xylans and galactans
and combinations
thereof.
[00123] In an embodiment, the one or more polysaccharides are fructans. In an
embodiment,
the one or more polysaccharides is inulin. Accordingly, in an embodiment, the
buccal dosage
form comprises about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree
of
polymerization of up to 60 and having an average degree of polymerization of
about 9 or greater.
In another embodiment, the buccal dosage comprises about 0.1% (w/w) to about
89.9% (w/w) of
inulin having a degree of polymerization of up to 60 and having an average
degree of
polymerization of about 9 or greater, wherein the one or more oligosaccharides
and the inulin
combined comprise about 55% (w/w) to about 99.9% (w/w) of the buccal dosage
form.
[00124] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60 or about 10 to about 60. In an embodiment, the inulin has a
degree of polymerization
of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin
has a degree of
polymerization of about 10 to about 60. In an embodiment, the inulin has an
average degree of
polymerization of about 10 or greater. In an embodiment, inulin is
commercially available, for
example, under the trade name Orafti inulin by Beneo Inc. (New Jersey,
U.S.A).
[00125] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract, the one
or more oligosaccharides and the one or more polysaccharides are present in a
weight ratio of
26
Date Recue/Date Received 2021-08-20

about 1:1000 to about 1:5, about 1:900 to about 1:5, about 1:800 to about 1:5,
about 1:700 to
about 1:5, about 1:600 to about 1:5, about 1:500 to about 1:5, about 1:400 to
about 1:5, about
1:300 to about 1:5, about 1:200 to about 1:5, about 1:150 to about 1:5, about
1:100 to about 1:5,
about 1:50 to about 1:5 of the one or more cannabinoids, and/or a cannabinoid
extract to the one
or more oligosaccharides and the one or more polysaccharides combined. In an
embodiment,
the one or more cannabinoids, and/or a cannabinoid extract, the one or more
oligosaccharides
and the one or more polysaccharides are present in a weight ratio of about
1:1000 to about 1:5,
about 1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to
about 1:300, about
1:1000 to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about
1:600, or about
1:1000 to about 1:700 of the one or more cannabinoids, and/or a cannabinoid
extract to the one
or more oligosaccharides and the one or more polysaccharides combined. In an
embodiment,
the one or more cannabinoids, and/or a cannabinoid extract, the one or more
oligosaccharides
are present in a weight ratio of about 1:900 to about 1:5, about 1:800 to
about 1:5, about 1:700
to about 1:5, about 1:600 to about 1:5, about 1:500 to about 1:5, about 1:400
to about 1:5, about
1:300 to about 1:5, about 1:200 to about 1:5, about 1:150 to about 1:5, about
1:100 to about 1:5,
about 1:400 to about 1:50, about 1:400 to about 1:100, about 1:300 to about
1:100, about 1:300,
about 1:200, about 1:150 or about 1:100 of the one or more cannabinoids,
and/or a cannabinoid
extract to the one or more oligosaccharides and the one or more
polysaccharides combined.
[00126] In an embodiment, the buccal dosage form optionally further comprises
one or more
additives selected from plasticizers, emulsifying agents, oils and/or fats,
flavourants, gelling
agents, pH modifying agents and lubricants.
[00127] In an embodiment, when the buccal dosage form is, for example, a hard
molded lozenge,
the buccal dosage form optionally further comprises one or more plasticizers.
[00128] In an embodiment, the buccal dosage form comprises about 2 % (w/w) to
about 15%
(w/w), about 2 % (w/w) to about 12% (w/w), about 2 % (w/w) to about 10% (w/w),
about 2 %
(w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to
about 6% (w/w),
about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the plasticizer. In an
embodiment, the
buccal dosage form comprises about 2 % (w/w) to about 10% (w/w), about 2 %
(w/w) to about
8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6%
(w/w), about 4 %
(w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizer. In
an embodiment, the
lozenge comprises about 5% (w/w) of the plasticizer.
[00129] In an embodiment, the one or more plasticizers is selected from
glycerin and
polyethylene glycol and combinations thereof. In an embodiment, the one or
more plasticizers
is glycerin.
[00130] In an embodiment, the buccal dosage form optionally further comprises
one or more
emulsifying agents. In an embodiment, the buccal dosage form comprises about
1% (w/w) or
less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less,
about 5%(w/w) or
27
Date Recue/Date Received 2021-08-20

less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less,
about 9% (w/w) or
less, or about 10% (w/w) or less of an emulsifying agent. In an embodiment,
the buccal dosage
form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w)
or less, about
4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying
agents. In an
embodiment, the buccal dosage form comprises about 0.1 % (w/w) to about 5%
(w/w), about 0.1
% (w/w) to about 4% (w/w), about 0.1 % (w/w) to about 3% (w/w), about 0.1 %
(w/w) to about
2% (w/w), about 0.1 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 1%
(w/w), about 0.5
% (w/w) to about 2% (w/w), about 1 % (w/w) to about 2% (w/w) of the one or
more emulsifying
agents.
[00131] In an embodiment, the buccal dosage form further comprises from about
0.5% (w/w) to
about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w)
to about
8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to
about 6%(w/w),
from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w)
of the one or
more emulsifying agents. In an embodiment, the buccal dosage form comprises
about 0.1 %
(w/w) to about 2% (w/w), or about 0.1 % (w/w) to about 1% (w/w) of the one or
more emulsifying
agents.
[00132] In an embodiment, the buccal dosage form optionally comprises about
1.0%( w/w) or
less of the one or more emulsifying agents. In an embodiment, the buccal
dosage form optionally
comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 03% (w/w)
or less, about
0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or
about 0.7% (w/w) or
less of the one or more emulsifying agents. In an embodiment, the buccal
dosage form comprises
about 0.1 % (w/w) to about 1% (w/w) of the one or more emulsifying agents.
[00133] In an embodiment, the buccal dosage form optionally further comprises
one or more oils
and/or fats. In an embodiment, the buccal dosage form further comprises about
10%(w/w) or
less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less,
about 6%(w/w) or
less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less,
about 2%(w/w) or
less, or about 1%(w/w) or less of the one or more oils and/or fats. In an
embodiment, the buccal
dosage form comprises about 0.1 % (w/w) to about 1% (w/w), about 0.1 % (w/w)
to about 2%
(w/w), about 0.1 % (w/w) to about 3% (w/w), about 0.1 % (w/w) to about 4%
(w/w) or about 0.1
% (w/w) to about 5% (w/w) of the one or more oils and/or fats.
[00134] In an embodiment, the buccal dosage form further comprises from about
0.5% (w/w) to
about 10% (w/w), from about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w)
to about 2%
(w/w), 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w),
from about 0.5%
(w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about
0.5% (w/w) to
about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w) of the one or more oils
and/or fats.
[00135] In an embodiment, the buccal dosage form optionally further comprises
about 1.0%(w/w)
or less of one or more oils and/or fats. In an embodiment, the buccal dosage
form further
28
Date Recue/Date Received 2021-08-20

comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w)
or less, about
OA% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or
about 0.7% (w/w) or
less of the one or more oils and/or fats. In an embodiment, the buccal dosage
form comprises
about 0.1 % (w/w) to about 1% (w/w) of the one or more oils and/or fats
[00136] In an embodiment, when the buccal dosage form is a soft chew lozenge,
the buccal
dosage form optionally further comprises one or more gelling agents. In an
embodiment, the
buccal dosage form further comprises about 25% or less, about 20% or less,
about 15% (w/w)
or less, about 10% (w/w) or less or about 5% (w/w) or less of the gelling
agent. In an embodiment,
the buccal dosage form further comprises of from about 1% (w/w) to about 25%
(w/w), about 1%
(w/w) to about 20% (w/w), about 1% (w/w) to about 15% (w/w), about 1% (w/w) to
about 10%
(w/w), about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about
8% (w/w) of the
one or more gelling agents.
[00137] In an embodiment, the buccal dosage form optionally further comprises
one or more
flavourants. In an embodiment, the buccal dosage form comprises about 5%(w/w)
or less, about
4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about
1%(w/w) or less of the
one or more flavourants.
[00138] In an embodiment, the buccal dosage form comprises about 1.0%(w/w) or
less of the
one or more flavourants. In an embodiment, the buccal dosage form comprises
about 0.1% (w/w)
or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w)
or less, about 0.5%
(w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the
one or more
flavourants. In an embodiment, the buccal dosage form comprises about 0.1%
(w/w) to about
2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5 % (w/w) to about 1%
(w/w), about
0.5 % (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 2% (w/w) of the
one or more
flavourants.
[00139] In an embodiment, the buccal dosage form optionally further comprises
one or more pH
modifying agents. In an embodiment, the buccal dosage form comprises about 1%
(w/w) or less,
about 2%(w/w) or less, about 3%(w/w) or less, or about 4%(w/w) or less of the
one or more pH
modifying agents. In an embodiment, the buccal dosage form comprises about
0.1% (w/w) to
about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5 % (w/w) to
about 1% (w/w),
about 0.5 % (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 2% (w/w) of
the one or more
pH modifying agents.
[00140] In an embodiment, the buccal dosage form comprises about 1.0%(w/w) or
less of the pH
modifying agent. In an embodiment, the buccal dosage form further comprises
about 0.1% (w/w),
about 0.2%(w/w), or about 0.3% (w/w) of the pH modifying agent.
[00141] In an embodiment, when the buccal dosage form, for example, is a
compressed tablet
lozenge, the buccal dosage form optionally further comprises one or more
lubricants. In an
embodiment, the buccal dosage form comprises about 5%(w/w) or less, about
4%(w/w) or less,
29
Date Recue/Date Received 2021-08-20

about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the
one or more
lubricants. In an embodiment, the buccal dosage form comprises about 0.1%
(w/w) to about 5%
(w/w), about 0.1% (w/w) to about 4% (w/w), about 0.1% (w/w) to about 3% (w/w),
about 0.1%
(w/w) to about 2% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.5 %
(w/w) to about 2%
(w/w), or about 0.1% (w/w) to about 1% (w/w) of the one or more lubricants.
[00142] The emulsifying agent is otherwise known as a surfactant or
emulsifier. In an
embodiment, the emulsifying agent or surfactants for use in the buccal dosage
forms of the
present invention comprise surfactants commonly used in the formulation of
pharmaceuticals.
In an embodiment, the one or more emulsifying agents are selected from ionic-
and non-ionic
surfactants and wetting agents. In an embodiment, the one or more emulsifying
agents are
selected from monoglycerides of fatty ester, diglycerides of fatty esters,
sucrose esters of fatty
acids, polyglycerol esters of fatty acids, acetylated tartaric acid esters of
monoglycerides,
acetylated tartaric acid esters of diglycerides, citric acid esters of
monoglycerides, citric acid
esters of diglycerides, lactylated monoglycerides, lactylated diglycerides,
lactylic esters of fatty
acids, polyglycerol esters of fatty acids, polyglycerol esters of
interesterified castor oil fatty acids,
polyoxyethylene fatty esters, propylene glycol alginates, propylene glycol
ether of
methylcellulose, propylene glycol mono fatty acid esters, quillaia extract,
sodium stearoy1-2-
lactylate, sodium stearate, stearyl monoglyceridyl citrate, D-a-tocopherol
polyethylene glycol
1000 succinate (TPGS, Vitamin E TPGS), polyglycerol polyricinoleate (PGPR),
polyoxy (40)
hydrogenated castor oil, ethoxylated castor oil, polyoxy hydrogenated castor
oils (e.g.
Cremophor@), polyglycolyzed glycerides, acetylated monoglycerides, sorbitan
fatty acid esters,
poloxamers, polyoxyethylene sorbitan fatty acid esters (e.g Tween@ series),
polyoxyethylene
derivatives (e.g., Brij series), monoglycerides or ethoxylated derivatives
thereof, diglycerides or
polyoxyethylene derivatives thereof, sodium docusate, sodium laurylsulfate,
cholic acid or
derivatives thereof, lecithin, hydroxylated lecithin, hydrolyzed lecithin, gum
Arabic, modified gum
Arabic, phospholipids, hydrocolloids and combinations thereof.
[00143] In an embodiment, the one or more emulsifying agents are selected from
gum Arabic,
modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed
lecithin. In an embodiment,
the lecithin is soy lecithin or sunflower lecithin. In an embodiment, the
lecithin is soy lecithin.
[00144] In an embodiment, the one or more oils are selected from long chain
triglycerides (LCT)
and medium chain triglycerides (MCTs). In an embodiment, the one or more oils
are medium
chain triglycerides (MCTs). In an embodiment, the one or more oils are
vegetable oils. In an
embodiment, the one or more vegetable oils are selected from soybean oil,
sunflower oil, olive
oil, palm oil, coconut oil, canola oil, peanut oil, cottonseed oil, corn oil,
safflower oil, sesame oil,
grape seed oil, hemp seed oil, and flaxseed oil, and combinations thereof. In
an embodiment,
the oils are selected from sunflower oil or coconut oil. In an embodiment, the
oil is coconut oil. In
an embodiment, the coconut oil is fractionated coconut oil.
Date Recue/Date Received 2021-08-20

[00145] In an embodiment, the one or more fats are animal fats or animal
derived fats. In an
embodiment, the animal or animal derived fats are selected from butter, ghee,
and milk fat.
[00146] In an embodiment, the one or more gelling agents are selected from
gelatin, pectin,
agar, carrageenan, alginate, gellan gum, xanthan gum, cellulose gum, and
modified starch and
combinations thereof. In an embodiment, the one or more gelling agents are
selected from
gelatin, agar, carrageenan, alginate, gellan gum, xanthan gum, cellulose gum,
and modified
starch and combinations thereof. In an embodiment, the gelling agent is
gelatin.
[00147] In an embodiment, the one or more pH modifying agents are food grade
acids or salts
thereof. In an embodiment, the one or more pH modifying agents are selected
from citric acid,
malic acid, tartaric acid and ascorbic acid and combinations therefore, and
salts thereof. In an
embodiment, the pH modifying agent is citric acid.
[00148] In an embodiment, the pH modifying agent is sodium bicarbonate or
potassium bitartrate.
[00149] In an embodiment, the one or more flavourants is an unsweetened
flavourant. In an
embodiment, the one or more flavourants are selected from synthetic flavor
oils, flavoring
aromatics, natural oils, extracts from plants, leaves, flowers, fruits and
combinations thereof. In
an embodiment, the one or more flavourants are selected from cinnamon oil, oil
of wintergreen,
peppermint oils, clove oil, bay oil, anise oil, eucalyptus, thyme oil, cedar
leave oil, oil of nutmeg,
oil of sage, oil of bitter almonds, cassia oil, vanilla, citrus oil, fruit
essences and menthol. In an
embodiment, the one or more flavourants are selected from eucalyptus,
peppermint oils and
menthol.
[00150] In an embodiment, the one or lubricants are selected from calcium
stearate,
hydrogenated castor oil, hydrogenated coconut oil, glyceryl tristearate,
lauric acid NF32,
magnesium stearate, light mineral oil, myristic acid, hydrogenated palm oil,
palmitic acid,
polyethylene glycol, potassium benzoate, sodium benzoate, sodium lauryl
sulfate, sodium
stearate, sodium stearyl fumarate, stearic acid, stearic acid, talc,
hydrogenated vegetable oil
type I and zinc stearate. In an embodiment, the lubricant is magnesium
stearate.
[00151] Accordingly, the present application includes a buccal dosage form
comprising:
(a) about 0.1% (w/w) to about 2% (w/w) or less of one or more cannabinoids,
and/or a
cannabinoid extract;
(b) about 10% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
and
(d) optionally 0.1% (w/w) to about 5% (w/w) of one or more oils and/or fats.
[00152] The present application includes a buccal dosage form comprising:
31
Date Recue/Date Received 2021-08-20

(a) about 0.1% (w/w) to about 2% (w/w) or less of one or more cannabinoids,
and/or a
cannabinoid extract;
(b) about 70% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) optionally about 1% (w/w) to about 2% (w/w) or less of one or more
emulsifying
agents.
[00153] The present application also includes a buccal dosage form comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 99.8% (w/w) of one or more oligosaccharides
having a
degree of polymerization (DP) of about 10 or less;
(c) about 0.1% (w/w) to about 89.9% (w/w) of one or more polysaccharides
having a
degree of polymerization (DP) up to about 80 and having an average degree of
polymerization of about 9 or greater, and
(d) optionally 0.1% (w/w) to about 5% (w/w) of one or more emulsifying agents.
[00154] The present application also includes a buccal dosage form comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 25% (w/w) to about 99.8% (w/w) of one or more oligosaccharides
having a
degree of polymerization (DP) of about 10 or less;
(c) about 0.1% (w/w) to about 74% (w/w) of one or more polysaccharides having
a degree
of polymerization (DP) up to about 80 and having an average degree of
polymerization
of about 9 or greater,
(d) optionally 0.1% (w/w) to about 5% (w/w) of one or more emulsifying agents,
and
(e) optionally 0.1% (w/w) to about 5% (w/w) of one or more oils and/or fats.
[00155] In an embodiment, the buccal dosage form is free of added sugars,
sweeteners and/or
sweetening agents as described above.
[00156] In an embodiment, the one or more oligosaccharides having a DP of
about 10 or less
are as described above.
[00157] In an embodiment, the one or more polysaccharides are as described
above.
[00158] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more oils and/or fats are as described above. In an
embodiment, the
buccal dosage form optionally further comprises one or more plasticizers,
flavourants, gelling
agents, pH modifying agents and lubricants as described above. In an
embodiment, the buccal
dosage form optionally further comprises one or more flavourants.
32
Date Recue/Date Received 2021-08-20

[00159] In an embodiment, the buccal dosage form may also comprise further
excipients used in
the formation of buccal dosage forms such as carriers (e.g., lactose or corn
starch) and binding
agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or
hydroxypropyl methylcellulose);
fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate);
disintegrants (e.g., potato
starch, sodium starch glycolate, croscarmellose sodium, and crospovidone); or
wetting agents
(e.g., sodium lauryl sulphate).
[00160] In an embodiment, the buccal dosage form optionally further comprises
a coating. In an
embodiment, the coating comprises carnauba wax, beeswax, gelatin, acetylated
monoglyceride,
starch, zein, shellac, ethyl cellulose, methylcellulose, hydroxypropyl
methylcellulose,
carboxymethyl cellulose, and combinations thereof. In an embodiment, the
coating provides a
glossy or semi-glossy appearance, a smooth surface, and/or a pleasant visual
aesthetic. In some
cases, the coating provides a hard outer coating.
[00161] In an embodiment, the buccal forms of the application do not comprise
a coating.
[00162] The Applicant has prepared lozenges comprising one or more
cannabinoids and/or
cannabinoid extract and one or more oligosaccharides having a degree of
polymerization of
about 10 or less. Therefore, in an embodiment, the buccal dosage form is a
lozenge.
[00163] In an embodiment, the lozenge is a hard molded lozenge, a soft chew
lozenge, a
compressed tablet lozenge, a soft lozenge, a troche. a cachou, a pill, a
capsule, a tab, a pellet,
a dragee or a pastille. In an embodiment, the lozenge is a compressed tablet
or troche. In an
embodiment, the lozenge is adapted for administration sublingually. In an
embodiment, the
lozenge is adapted for administration as a lollipop. In an embodiment, the
lozenge can be
swallowed. In an embodiment, the lozenge is a hard molded lozenge, soft chew
lozenge, or a
compressed tablet lozenge. In an embodiment, the lozenge is a hard molded
lozenge, or a
compressed tablet lozenge.
Hard Molded Lozenge
[00164] The Applicant has prepared hard molded lozenges comprising the one or
more
oligosaccharides such as fructo-oligosaccharides alone or in combination with
one or more
polysaccharides such as inulin, and optionally including a plasticizer such as
glycerin. The
Applicant has also prepared one or more polysaccharides such as inulin and a
plasticizer such
glycerin. In an embodiment, the buccal dosage forms have been prepared without
any added
sugars, sweeteners, or sweetening agents.
[00165] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less.
33
Date Recue/Date Received 2021-08-20

[00166] In an embodiment, the hard molded lozenge comprises about 10% (w/w) to
about 99.9%
(w/w), about 15% (w/w) to about 99.9% (w/w), about 20% (w/w) to about 99.9%
(w/w), about
25% (w/w) to about 99.9% (w/w), about 30% (w/w) to about 99.9% (w/w), about
35% (w/w) to
about 99.9% (w/w), about 40% (w/w) to about 99.9% (w/w), about 45% (w/w) to
about 99.9%
(w/w), about 50% (w/w) to about 99.9% (w/w), about 55% (w/w) to about 99.9%
(w/w), about
60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about
70% (w/w) to
about 99.9% (w/w), about 75% (w/w) to about 99.9% (w/w), about 80% (w/w) to
about 99.9%
(w/w), about 85% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 99.9%
(w/w), about
95% (w/w) to about 99.9% (w/w), about 96% (w/w) to about 99.9% (w/w), about
97% (w/w) to
about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to
about 99.9%
(w/w), about 99.5% (w/w) to about 99.9% (w/w), about 99.7% (w/w) to about
99.9% (w/w), about
99.8% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99% (w/w), about
96% (w/w) to
about 99% (w/w), about 97% (w/w) to about 99% (w/w), about 98% (w/w) to about
99% (w/w),
about 98% (w/w) to about 98.5% (w/w), about 96% (w/w) to about 98.5% (w/w), of
one or more
oligosaccharides. In an embodiment, the hard molded lozenge comprises about
10% (w/w) to
about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about
95% (w/w),
about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about
25% (w/w) to
about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about
75% (w/w),
about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about
30% (w/w) to
about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 40% (w/w) to about
60% (w/w),
about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about
20% (w/w) to
about 60% (w/w), about 20% (w/w) to about 50% (w/w), about 10% (w/w) to about
50% (w/w), or
about 10% (w/w) to about 75% (w/w) of one or more oligosaccharides. In an
embodiment, the
hard molded lozenge comprises about 85% (w/w) to about 99.9% (w/w), about 90%
(w/w) to
about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about 96% (w/w) to
about 99.9%
(w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9%
(w/w), about
99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w), about
99.9% (w/w)
to about 99.9% (w/w), about 99.8% (w/w) to about 99.9% (w/w), about 95% (w/w)
to about 99%
(w/w), about 96% (w/w) to about 99% (w/w), about 97% (w/w) to about 99% (w/w),
about 98%
(w/w) to about 99% (w/w), about 98% (w/w) to about 98.5% (w/w) or about 96%
(w/w) to about
98.5% (w/w) of one or more oligosaccharides. In an embodiment, the hard molded
lozenge
comprises about 96% (w/w) to about 99% (w/w) of one or more oligosaccharides.
In an
embodiment, the hard molded lozenge comprises about 96% (w/w) to about 98.5%
(w/w) of one
or more oligosaccharides.
[00167] Accordingly, the present application includes a hard molded lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 10% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
34
Date Recue/Date Received 2021-08-20

[00168] In an embodiment, the hard molded lozenge is comprised primarily of
the one or more
oligosaccharides. In an embodiment, the hard molded lozenge comprises more
than about 70%
of the one or more oligosaccharides having a degree of polymerization of about
10 or less
[00169] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 70% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
[00170] In an embodiment, the present application includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 95% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less.
[00171] In an embodiment, the hard molded lozenge comprises about 96% (w/w) to
about 99.9%
(w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9%
(w/w), about
99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w), about
99.7% (w/w)
to about 99.9% (w/w) or about 99.8% (w/w) to about 99.9% (w/w) of the one or
more
oligosaccharides. In an embodiment, the hard molded lozenge comprises about
96% (w/w) to
about 99% (w/w) of the one or more oligosaccharides. In an embodiment, the
hard molded
lozenge comprises about 96% (w/w) to about 98.5% (w/w) of the one or more
oligosaccharides.
[00172] In an embodiment, the hard molded lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00173] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 8 or
less. In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 8 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 10 or less. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9 or
less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 8 or less. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 2 to about 10. In an embodiment, the one or more
oligosaccharides have
a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2
to about 7, about 2
to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about
3 to about 8, about
3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8, about
3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
one or more
Date Recue/Date Received 2021-08-20

oligosaccharides have a degree of polymerization of about 2 to about 9, about
3 to about 9, about
2 to about 8 or about 3 to about 8. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 9. In an embodiment, the one or
more
oligosaccharides have a degree of polymerization of about 2 to about 8.
[00174] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 3 to about 10. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about
5. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 3 to
about 9, or about
3 to about 8. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 3 to about 9. In some embodiments, the one or more
oligosaccharides
have a degree of polymerization of about 3 to about 8.
[00175] In an embodiment, the hard molded lozenge comprises the one or more
oligosaccharides
having a degree of polymerization of about 10 or less as described above. In
an embodiment,
the one or more oligosaccharides are selected from digestible oligosaccharides
and non-
digestible oligosaccharides and combinations thereof as described above. In an
embodiment,
the one or more oligosaccharides are one or non-digestible oligosaccharide as
described above.
In an embodiment, the one or more oligosaccharides are selected from fructo-
oligosaccharides
(FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-
oligosaccharides,
xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family
of
oligosaccharides, and combinations thereof. In an embodiment, the one or more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
[00176] In an embodiment, the fructo-oligosaccharide (FOS) is produced by the
partial enzymatic
hydrolysis of inulin from natural sources such as from chicory, artichoke,
yacon, dahlia, onion,
garlic, asparagus, banana or agave, or the FOS is produced by the partial
enzymatic hydrolysis
from chicory inulin. In an embodiment, FOS is prepared by enzymatic synthesis
with sucrose by
methods known in the art, for example, by the transfructosylation of sucrose
by 13-
fructofuranosidases. In an embodiment, the FOS is Orafti P95 Oligofructose
from Beneo GmbH
New Jersey, U.S.A.
[00177] In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides. In an
embodiment, the fructo-oligosaccharides has a degree of polymerization of
about 10 or less,
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the fructo-oligosaccharides has degree of polymerization of about
10 or less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 8 or
36
Date Recue/Date Received 2021-08-20

less. In an embodiment, the fructo-oligosaccharides has a degree of
polymerization of about 9
or less. In an embodiment, the fructo-oligosaccharides has a degree of
polymerization of about
8 or less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 10 or less. In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 2 to about 8 or less. In an embodiment, the fructo-
oligosaccharide has
a degree of polymerization of about 2 to about 10. In an embodiment, the
fructo-oligosaccharide
has a degree of polymerization of about 2 to about 9, about 2 to about 8,
about 2 to about 7,
about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about
9, about 3 to about
8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an
embodiment, the fructo-
oligosaccharide has a degree of polymerization of about 2 to about 9, about 2
to about 8, about
3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
fructo-
oligosaccharide has a degree of polymerization of about 2 to about 9, about 3
to about 9, about
2 to about 8 or about 3 to about 8. In an embodiment, the fructo-
oligosaccharide has a degree
of polymerization of about 2 to about 9. In an embodiment, the fructo-
oligosaccharide has a
degree of polymerization of about 2 to about 8. In an embodiment, the fructo-
oligosaccharides
has a degree of polymerization of about 3 to about 10. In an embodiment, the
fructo-
oligosaccharide has a degree of polymerization about 3 to about 9, about 3 to
about 8, about 3
to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the
fructo-oligosaccharide
has a degree of polymerization of about 3 to about 9, about 3 to about 8, or
about 3 to about 5.
In an embodiment, the fructo-oligosaccharide has a degree of polymerization of
about 3 to about
9, or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 3 to about 9. In an embodiment, the fructo-
oligosaccharide has a degree
of polymerization of about 3 to about 8.
[00178] For the purposes of this application, fructo-oligosaccharide is
considered to include
inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the
oligosaccharide is
fructo-oligosaccharide having a DP of 2). Therefore, when inulobiose is
considered to be an
oligosaccharide, fructo-oligosaccharide having a DP of, for example, 10 or
less which comprises
inulobiose as a natural component is fructo-oligosaccharide having a DP of
about 2 to about 10
or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about
8) wherein the
inulobiose occurring as a natural component of the fructo-oligosaccharide is
an oligosaccharide
having a DP of 2. Further, when inulobiose is considered to be
oligosaccharide, fructo-
oligosaccharide having a DP of, for example, 10 or less which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
(such as about
2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a
heterogenous mixture
of oligosaccharides of different DPs of about 2 to about 10 or less including
inulobiose and
comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) not including
inulobiose.
37
Date Recue/Date Received 2021-08-20

[00179] It would be appreciated by a person skilled in the art, that when
inulobiose is considered
to be a sugar, then the same fructo-oligosaccharide having a DP of, for
example, 10 or less which
comprises inulobiose as a natural component described above is fructo-
oligosaccharide having
a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to
about 9 or about 3
to about 8) wherein the inulobiose occurring as a natural component of the
fructo-oligosaccharide
is included as a component of the naturally occurring sugars in the fructo-
oligosaccharide.
Accordingly, when inulobiose is considered to be a sugar, then fructo-
oligosaccharide having a
DP of, for example, 10 or less comprising inulobiose as a natural component is
fructo-
oligosaccharide having a DP of about 3 to about 10 or less which comprises a
heterogenous
mixture of oligosaccharides of different DPs of about 3 to about 10 or less
not including inulobiose
and comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) including
inulobiose.
[00180] In an embodiment, the fructo-oligosaccharide having a DP of, for
example, 10 or less
comprising inulobiose as a natural component comprises about 0.1 % (w/w) to
about 8% (w/w),
about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 %
(w/w) to about
7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7%
(w/w), about 0.1
% (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 %
(w/w) to about 6%
(w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5%
(w/w), about 1 %
(w/w) to about 5% (w/w),about 0.1 % (w/w) to about 4% (w/w), about 0.5 % (w/w)
to about 4%
(w/w), about 1 % (w/w) to about 4% (w/w), about 0.5 % (w/w) to about 3% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an embodiment,
the fructo-oligosaccharide having a DP of, for example, 10 or less comprising
inulobiose as a
natural component comprises about 0.1 % (w/w) to about 4% (w/w), about 1 %
(w/w) to about
3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to about 3%
(w/w), of inulobiose
on a dry solid basis of the total weight of the fructo-oligosaccharide.
[00181] In an embodiment, when inulobiose is defined as a fibre, the fructo-
oligosaccharide
having a DP of, for example, about 10 or less or, for example, a DP of about 2
to about 10 or
less, comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5%
(w/w) of
monosaccharides and/or disaccharides on a dry solid basis of the total weight
of the fructo-
oligosaccharide. In an embodiment, when inulobiose is defined as a sugar, the
fructo-
oligosaccharide having a DP of, for example, about 10 or less or, for example,
a DP of about 3
to about 10 or less, comprises about 1% (w/w) to about 8% (w/w) or 1% (w/w) to
about 10%
(w/w) of monosaccharides and/or disaccharides on a dry solid basis of the
total weight of the
fructo-oligosaccharide.
[00182] In an embodiment, the buccal dosage forms of the present application
are free of added
sugars, sweeteners, and/or sweetening agents as described above.
38
Date Recue/Date Received 2021-08-20

[00183] It would be appreciated by a person skilled in the art that the hard
molded lozenges of
the application may comprise residual water resulting from the manufacturing
process. In an
embodiment, the buccal dosage form comprises about 5% (w/w) or less, about 4%
(w/w) or less,
about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about
0.5% (w/w) or
less water on a total weight of the hard molded lozenge basis. In an
embodiment, the buccal
dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1%
(w/w) or less,
or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge
basis.
[00184] In an embodiment, the present application includes a hard molded
lozenge comprising
the one or more cannabinoids, and/or a cannabinoid extract as described above.
In an
embodiment, the present application also includes a hard molded lozenge
comprising the one or
more cannabinoids as described above. In an embodiment, the present
application includes a
hard molded lozenge comprising the one or more cannabinoid extracts as
described above. In
an embodiment, the one or more cannabinoid extracts is a cannabinoid
distillate. In an
embodiment, the one or more cannabinoids is selected from THC and CBD and
combinations
thereof and combinations thereof. In an embodiment, the one or more
cannabinoids is THC.
[00185] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides.
[00186] In an embodiment, the hard molded lozenge comprises 0.1% (w/w) to
about 3% (w/w),
about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one
or more
cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 03% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
hard molded
lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or 0.1%
(w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid
extract.
[00187] In an embodiment, the hard molded lozenge of the application can be
used to administer
any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoid
extract may be
in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg,
about 0.1mg to
about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg,
about 0.1 mg to
about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about
0.1 mg to
about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
39
Date Recue/Date Received 2021-08-20

cannabinoid extract is or comprises THC and typical doses of THC may be in the
range of about
0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15
mg, about 0.1
mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg,
about 0.1 mg to
about 2 mg, or 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is or comprises THC and typical doses of THC may be in the
range of about
0.1 mg to about 10 mg. In an embodiment, the one or more cannabinoids and/or
cannabinoid
extract is or comprises THC and typical doses of THC may be about 10mg, about
5 mg, about
2.5 mg, about 2 mg, about 1mg, about 0.5 mg or about 0.1mg. In an embodiment,
the one or
more cannabinoids and/or cannabinoid extract is or comprises THC and typical
doses of THC
may be about 10mg, about 5mg, about 2.5 mg, or about 0.1mg.
[00188] In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is or
comprises CBD and typical doses of CBD may be in the range of about 0.1 mg to
about 500 mg,
about 0.1mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to
about 250 mg,
about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to
about 50 mg,
about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to
about 5 mg, about
0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the
one or more
cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses
of CBD may be
in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1
mg. In an
embodiment the hard molded lozenge comprises more than one cannabinoid and/or
cannabinoid
extract and the buccal dosage form comprises a combination of the suitable
doses of each of the
cannabinoid and/or cannabinoid extract. In an embodiment the hard molded
lozenge comprises
THC and CBD, and the buccal dosage form comprises a combination of the
suitable doses of
THC and CDB. In an embodiment, the hard molded lozenge comprises 10mg of THC
and 2mg
of CBD. In an embodiment, the hard molded lozenge comprises equal amounts of
THC and CBD.
In an embodiment, the hard molded lozenge comprises 5mg of THC and 5mg of CBD.
In an
embodiment, the hard molded lozenge comprises 2.5mg of THC and 2.5mg of CBD.
[00189] In an embodiment, the cannabinoid extract is purified such that one or
more cannabinoid
is present at greater than about 80% (w/w), greater than about 85% or greater
than about 95%
of the total extract (w/w). In an embodiment, the hard molded lozenge
comprises about 0.1%
(w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to
about 1% (w/w)
of a cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to
about 20 mg,
about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to
about 5 mg, about
0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or 0.1 mg to about 1 mg of
THC. In an
embodiment, the cannabinoid extract comprises THC of about 0.1 mg to about 10
mg. In an
embodiment, the hard molded lozenge comprises 0.1% (w/w) to about 2% (w/w), or
0.1% (w/w)
to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract
comprises about 10mg,
about 5 mg, about 2.5 mg, about 2 mg, about 1mg, about 0.5 mg or about 0.1mg
of THC.
Date Recue/Date Received 2021-08-20

[00190] As the Applicant has prepared a hard molded lozenge comprising about
1% (w/w) of a
cannabinoid extract that comprises about 10mg of THC. Accordingly, the
Applicant has prepared
a high potency hard molded lozenge. Therefore, in an embodiment, the hard
molded lozenge is
a high potency hard molded lozenge. Accordingly, in an embodiment, the present
application
includes a high potency hard molded lozenge.
[00191] In an embodiment, the hard molded lozenge optionally further comprises
one or more
polysaccharides. In an embodiment, the one or more polysaccharides have a
degree of
polymerization of up to about 80 and have an average degree of polymerization
of about 9 or
greater. In an embodiment, when present the added % (w/w) of the one or more
polysaccharides
replaces an equal % (w/w) of the one or more oligosaccharides in the hard
molded lozenge.
[00192] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less;
and
(c) one or more polysaccharides having a degree of polymerization of up to
about 80 and
have an average degree of polymerization of about 9 or greater.
[00193] In an embodiment, when one or more polysaccharides are present, the
hard molded
lozenge comprises about 10% (w/w) to about 99.8% (w/w), about 15% (w/w) to
about 99.8%
(w/w), about 20% (w/w) to about 99.8.9% (w/w), about 25% (w/w) to about 99.8%
(w/w), about
30% (w/w) to about 99.8% (w/w), about 35% (w/w) to about 99.8% (w/w), about
40% (w/w) to
about 99.8% (w/w), about 45% (w/w) to about 99.8% (w/w), about 50% (w/w) to
about 99.8%
(w/w), about 55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8%
(w/w), about
65% (w/w) to about 99.8% (w/w), about 70% (w/w) to about 99.8% (w/w), about
75% (w/w) to
about 99.8% (w/w), about 80% (w/w) to about 99.8% (w/w), about 85% (w/w) to
about 99.8%
(w/w), about 90% (w/w) to about 99.8% (w/w), about 95% (w/w) to about 99.8%
(w/w), about
96% (w/w) to about 99.8% (w/w), about 97% (w/w) to about 99.8% (w/w) or about
98% (w/w) to
about 99.8% (w/w) of one or more oligosaccharides. In an embodiment, the
buccal dosage form
comprises about 50% (w/w) to about 99.8% (w/w), about 55% (w/w) to about 99.8%
(w/w), about
60% (w/w) to about 99.8% (w/w), about 65% (w/w) to about 99.8% (w/w), about
70% (w/w) to
about 99.8% (w/w), about 75% (w/w) to about 99.8% (w/w), about 80% (w/w) to
about 99.8%
(w/w), about 85% (w/w) to about 99.8% (w/w), about 90% (w/w) to about 99.8%
(w/w), about
95% (w/w) to about 99.8% (w/w), about 96% (w/w) to about 99.8% (w/w), about
97% (w/w) to
about 99.8% (w/w), about 98% (w/w) to about 99.8% (w/w), about 99% (w/w) to
about 99.8%
(w/w), about 99.5% (w/w) to about 99.8% (w/w), about 99.7% (w/w) to about
99.8% (w/w) or
about 99.8% (w/w) to about 99.8% (w/w) of one or more oligosaccharides. In an
embodiment,
the hard molded lozenge comprises about 10% (w/w) to about 95% (w/w), about
15% (w/w) to
about 95% (w/w), about 20% (w/w) to about 95% (w/w), about 25% (w/w) to about
95% (w/w),
41
Date Recue/Date Received 2021-08-20

about 25% (w/w) to about 90% (w/w), about 25% (w/w) to about 85% (w/w), about
25% (w/w) to
about 80% (w/w), about 25% (w/w) to about 75% (w/w), about 25% (w/w) to about
60% (w/w),
about 25% (w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about
40% (w/w) to
about 50% (w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about
55% (w/w),
about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about 50% (w/w), about
10% (w/w) to
about 50% (w/w), or about 10% (w/w) to about 75% (w/w) of one or more
oligosaccharides. In
an embodiment, the buccal dosage form comprises about 50% (w/w) to about 99.8%
(w/w), about
55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8% (w/w). In an
embodiment, the
buccal dosage form comprises about 85% (w/w) to about 99.8% (w/w), about 90%
(w/w) to about
99.8% (w/w), about 95% (w/w) to about 99.8% (w/w), about 96% (w/w) to about
99.8% (w/w),
about 97% (w/w) to about 99.8% (w/w), about 98% (w/w) to about 99.8% (w/w),
about 99% (w/w)
to about 99.8% (w/w), about 99.5% (w/w) to about 99.8% (w/w), about 99.8%
(w/w) to about
99.8% (w/w) or about 99.8% (w/w) to about 99.8% (w/w) of one or more
oligosaccharides.
[00194] In an embodiment, the hard molded lozenge comprises about 0.1% (w/w)
to about 89.9%
(w/w), about 0.5% (w/w) to about 89.9% (w/w), about 1% (w/w) to about 89.9%
(w/w), about 5%
(w/w) to about 89.9% (w/w), about 10% (w/w) to about 89.9%(w/w), about 15%
(w/w) to about
89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about
89.9%(w/w),
about 30% (w/w) to about 89.9% (w/w), about 35% (w/w) to about 89.9% (w/w),
about 40% (w/w)
to about 89.9%(w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w) to
about 89.9%
(w/w), about 55% (w/w) to about 89.9%(w/w), about 60% (w/w) to about 89.9%
(w/w), about 65%
(w/w) to about 89.9% (w/w), about 70% (w/w) to about 89.9%(w/w), about 75%
(w/w) to about
89.9% (w/w), about 80% (w/w) to about 89.9% (w/w), about 85% (w/w) to about
89.9% (w/w) of
one or more polysaccharides. In an embodiment, the buccal dosage form
comprises about 0.1%
(w/w) to about 88.9% (w/w), about 0.1% (w/w) to about 80% (w/w), about 0.1%
(w/w) to about
60% (w/w), about 0.1% (w/w) to about 50% (w/w), about 0.1% (w/w) to about 60%
(w/w), about
0.1% (w/w) to about 70% (w/w), about 5% (w/w) to about 50% (w/w), about 10%
(w/w) to about
70%(w/w), about 15% (w/w) to about 60% (w/w), about 20% (w/w) to about 75%
(w/w), about
25% (w/w) to about 75%(w/w), 0.1% (w/w) to about 74% (w/w), about 40% (w/w) to
about 70%
(w/w), about 10% (w/w) to about 30%(w/w), about 15% (w/w) to about 25% (w/w),
about 50%
(w/w) to about 75% (w/w), about 50% (w/w) to about 74% (w/w), about 25% (w/w)
to about 85%
(w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 60% (w/w),
about 25%
(w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w)
to about 50%
(w/w), 40% (w/w) to about 60% (w/w), about 45% (w/w) to about 50% (w/w), about
45% (w/w) to
about 55% (w/w), about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about
50% (w/w),
about 10% (w/w) to about 50% (w/w), or about 10% (w/w) to about 75% (w/w) of
one or more of
one or more polysaccharides.
42
Date Recue/Date Received 2021-08-20

[00195] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 99.9 % (w/w) of the
buccal
dosage form.
[00196] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 60% (w/w) to about 99.9% (w/w), about
65% (w/w) to
about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to
about 99.9%
(w/w), about 80% (w/w) to about 99.9% (w/w), about 85% (w/w) to about 99.9%
(w/w), about
90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about
97% (w/w) to
about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to
about 99.9%
(w/w), about 99.5% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 98%
(w/w), about
90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w) or about 90%
(w/w) to about
95% (w/w) of the hard molded lozenge.
[00197] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
[00198] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00199] In an embodiment, the one or more polysaccharides are selected from
the
polysaccharides described above. In an embodiment, the one or more
polysaccharides is inulin.
Accordingly, in an embodiment, the buccal dosage form comprises about 0.1%
(w/w) to about
89.9% (w/w) of inulin having a degree of polymerization of up to 60 and having
an average degree
of polymerization of about 9 or greater. In another embodiment, the buccal
dosage comprises
about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree of
polymerization of up to 60
and having an average degree of polymerization of about 9 or greater, wherein
the one or more
oligosaccharides and the inulin combined comprise about 95% (w/w) to about
99.9% (w/w) of the
buccal dosage form.
[00200] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a
degree of
polymerization of about 3 to about 60, or about 10 to about 60. In an
embodiment, the inulin has
a degree of polymerization of about 10 to about 60. In an embodiment, the
inulin has an average
degree of polymerization of about 10 or greater. In an embodiment, the inulin
is Orafti inulin by
Beneo Inc. (New Jersey, USA).
[00201] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
43
Date Recue/Date Received 2021-08-20

to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides.
[00202] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from emulsifying agents, oils and/or fats, flavourants, and
pH modifying agents
as described above.
[00203] In an embodiment, the hard molded lozenge optionally further comprises
one or more
emulsifying agents. In an embodiment, the buccal dosage form comprises about
1% (w/w) or
less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less,
about 5%(w/w) or
less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less,
about 9% (w/w) or
less, or about 10% (w/w) or less of an emulsifying agent. In an embodiment,
the buccal dosage
form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w)
or less, about
4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying
agents. In an
embodiment, the hard molded lozenge comprises about 0.5% (w/w) or less, about
1% (w/w) or
less, about 2%(w/w), about 3% (w/w) or less, about 4% (w/w) or less, or about
5%(w/w) or less
of the one or more emulsifying agents. In an embodiment, the hard molded
lozenge comprises
about 0.5% (w/w) or less, about 1% (w/w) or less or about 2%(w/w) or less of
the one or more
emulsifying agents. In an embodiment, the hard molded lozenge comprises about
0.1% (w/w) to
about 0.5% (w/w), about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to
about 2% (w/w),
about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or
about 0.1% (w/w)
to about 4% (w/w) of the one or more emulsifying agents.
[00204] In an embodiment, the hard molded lozenge further comprises from about
0.5% (w/w) to
about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w)
to about
8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to
about 6%(w/w),
from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about
4%(w/w), about 0.5%
(w/w) to about 3%(w/w), about 0.5% (w/w) to about 2%(w/w), about 0.5% (w/w) to
about 1%(w/w)
of the one or more emulsifying agents. In an embodiment, the hard molded
lozenge comprises
from about 0.5% (w/w) to about 5%(w/w), or from about 0.5% (w/w) to about
4%(w/w) of the one
or more emulsifying agents.
[00205] In an embodiment, the hard molded lozenge optionally comprises about
2.0%( w/w) or
less of the one or more emulsifying agents. In an embodiment, the hard molded
lozenge
optionally comprises about 1.0% (w/w) or less of the one or more emulsifying
agents. In an
embodiment, the buccal dosage form optionally comprises about 0.1% (w/w) or
less, about
0.2%(w/w) or less, about 0.3% (w/w) or less, about OA% (w/w) or less, about
0.5% (w/w) or less,
about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more
emulsifying agents. In
an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to about 1%
(w/w) of the
one or more emulsifying agents.
44
Date Recue/Date Received 2021-08-20

[00206] In an embodiment, the hard molded lozenge optionally further comprises
one or more
oils and/or fats. In an embodiment, the hard molded lozenge further comprises
about 10%(w/w)
or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less,
about 6%(w/w) or
less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less,
about 2%(w/w) or
less, or about 1%(w/w) or less, about 0.5% (w/w) or less of the one or more
oils and/or fats. In
an embodiment, the hard molded lozenge further comprises about 3%(w/w) or
less, about
2%(w/w) or less, about 1%(w/w) or less, about 0.5% (w/w) or less of the one or
more oils and/or
fats. In an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to
about 0.5%
(w/w), 0.1% (w/w) to about 1% (w/w), about 0.5% (w/w) to about 1% (w/w), about
0.5% (w/w) to
about 2% (w/w), about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about
3% (w/w),about
0.1% (w/w) to about 4% (w/w) or about 0.1% (w/w) to about 5% (w/w) of the one
or more oils
and/or fats.
[00207] In an embodiment, the hard molded lozenge further comprises from about
0.5% (w/w) to
about 10% (w/w), about 0.5% (w/w) to about 9%(w/w), about 0.5% (w/w) to about
8%(w/w), about
0.5% (w/w) to about 7%(w/w), about 0.5% (w/w) to about 6%(w/w), about 0.5%
(w/w) to about
5%(w/w), about 0.5% (w/w) to about 4%(w/w), about 0.5% (w/w) to about 3%(w/w),
about 0.5%
(w/w) to about 3%(w/w), about 0.5% (w/w) to about 2% (w/w) or about 0.5% (w/w)
to about
1%(w/w) of the one or more oils and/or fats.
[00208] In an embodiment, the hard molded lozenge optionally further comprises
about 2%(w/w)
or less of one or more oils and/or fats. In an embodiment, the hard molded
lozenge optionally
further comprises about 1%(w/w) or less of one or more oils and/or fats. In an
embodiment, the
buccal dosage form further comprises about 0.1% (w/w) or less, about 0.2%(w/w)
or less, about
03% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about
0.6% (w/w) or less,
or about 0.7% (w/w) or less of the one or more oils and/or fats. In an
embodiment, the hard
molded lozenge comprises about 0.5 % (w/w) to about 1% (w/w), about 0.5 %
(w/w) to about 2%
(w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more oils and/or fats.
[00209] In an embodiment, the hard molded lozenge optionally further comprises
one or more
flavourants. In an embodiment, the hard molded lozenge comprises about 5%(w/w)
or less, about
4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about
1%(w/w) or less of the
one or more flavourants. In an embodiment, the hard molded lozenge comprises
about 2%(w/w)
or less, or about 1%(w/w) or less of the one or more flavourants. In an
embodiment, the hard
molded lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w)
to about 2%
(w/w), about 0.1% (w/w) to about 1% (w/w), about 0.5% (w/w) to about 1% (w/w),
or about 0.1%
(w/w) to about 0.5% (w/w) of the one or more flavourants.
[00210] In an embodiment, the hard molded lozenge comprises about 2%(w/w) or
less of the one
or more flavourants. In an embodiment, the hard molded lozenge comprises about
1%(w/w) or
less of the one or more flavourants. In an embodiment, the hard molded lozenge
comprises about
Date Recue/Date Received 2021-08-20

0.1% (w/w), about 0.2%(w/w), about 0.3% (w/w), about OA% (w/w), about 0.5%
(w/w), about
0.6% (w/w), or about 0.7% (w/w) of the one or more flavourants. In an
embodiment, the hard
molded lozenge comprises about 0.1% (w/w) to about 0.5% (w/w), about 0.1%
(w/w) to about
1.5% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more
flavourants.
[00211] In an embodiment, the hard molded lozenge optionally further comprises
one or more
pH modifying agents. In an embodiment, the hard molded lozenge comprises about
1.0%(w/w)
or less of the pH modifying agent. In an embodiment, the hard molded lozenge
further comprises
about 0.1% (w/w) or less, about 0.2%(w/w) or less, or about 0.3% (w/w) or less
of the pH
modifying agent. In an embodiment, the hard molded lozenge comprises about
0.1% (w/w) to
about 0.5% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.1% (w/w) to
about 1% (w/w) of
the one or more flavourants.
[00212] In an embodiment, the hard molded lozenge is comprised primarily of
the one or more
oligosaccharides. Accordingly, in an embodiment, the present application
includes a hard molded
lozenge comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 95% (w/w) to about 99.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents;
and
(d) optionally about 0.1% (w/w) to about 2% (w/w) of one or more oils and/or
fats.
[00213] In an embodiment, the hard molded lozenge comprises about 96% (w/w) to
about 99.9%
(w/w) of one or more oligosaccharides, about 97% (w/w) to about 99.9% (w/w),
about 98% (w/w)
to about 99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w)
to about 99.9%
(w/w), about 99.7% (w/w) to about 99.9% (w/w) or about 99.8% (w/w) to about
99.9% (w/w) of
one or more oligosaccharides. In an embodiment, the hard molded lozenge
comprises about
96% (w/w) to about 99% (w/w) of one or more oligosaccharides. In an
embodiment, the hard
molded lozenge comprises about 96% (w/w) to about 98.5% (w/w) of one or more
oligosaccharides.
[00214] Accordingly, in an embodiment, the present application also includes a
hard molded
lozenge comprising:
(a) about 0.1% (w/w) to about 1% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 96% (w/w) to about 98.5% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
46
Date Recue/Date Received 2021-08-20

(c) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents;
and
(d) optionally about 0.1% (w/w) to about 2% (w/w) of one or more oils and/or
fats.
[00215] The present application also includes a hard molded lozenge m
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 99.8% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 89.9% (w/w) of one or more polysaccharides
having a
degree of polymerization up to about 80 and having an average degree of
polymerization
of about 9 or greater, and
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents.
[00216] The present application also includes a buccal dosage form comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 25% (w/w) to about 99.8% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 74% (w/w) of one or more polysaccharides having
a degree
of polymerization up to about 80 and having an average degree of
polymerization of
about 9 or greater, and
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents.
[00217] In an embodiment, the hard molded lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00218] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more oils and/or fats are as described above. In an
embodiment, the
hard molded lozenge optionally further comprises one or more plasticizers,
flavourants, gelling
agents, pH modifying agents and lubricants as described above.
[00219] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more emulsifying agents as described above. In an embodiment, the
hard molded
lozenge further comprises about 1%( w/w) or less of the one or more
emulsifying agents as
described above. In an embodiment, the hard molded lozenge further comprises
about 0.1%
(w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.1 %
(w/w) to about 1 %
(w/w) about 0.1 % (w/w) to about 0.5 % (w/w) or about 05% (w/w) to about 1%
(w/w) of one or
more emulsifying agents as described above. In an embodiment, the hard molded
lozenge
optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about
03% (w/w) or
less, about OA% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or
less, or about 0.7%
47
Date Recue/Date Received 2021-08-20

(w/w) or less of the one or more emulsifying agents. In an embodiment, the
hard molded lozenge
optionally comprises about 0.5% (w/w) or less of the one or more emulsifying
agents
[00220] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more emulsifying agents are selected from gum Arabic,
modified gum
Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an
embodiment, the lecithin is
soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin.
[00221] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more oils and/or fats. In an embodiment, the hard molded lozenge
comprises about
1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the
buccal dosage form
comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.1 % (w/w) to about
1% (w/w), about
05% (w/w) to about 1% (w/w) or about 0.1 % (w/w) to about 2% (w/w one or more
oils and/or
fats. In an embodiment, the one or more oils and/or fats are as described
above. In an
embodiment, the one or more oils are vegetable oils. In an embodiment, the
hard molded lozenge
does not comprise a fat.
[00222] In an embodiment, the hard molded lozenge optionally comprises about
1% (w/w) or less
of the one or more pH modifying agents. In an embodiment, the hard molded
lozenge optionally
comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about
1% (w/w) or
about 0.1% (w/w) to about 1% (w/w) of the one or more pH modifying agents. In
an embodiment,
the one or more pH modifying agents are as described above. In an embodiment,
the one or
more pH modifying agents are selected from citric acid, malic acid, tartaric
acid and ascorbic
acid and combinations therefore, and salts thereof. thereof. In an embodiment,
the pH modifying
agent is citric acid.
[00223] In an embodiment, the hard molded lozenge optionally comprises about
1% (w/w) or less
of the one or more flavourants. In an embodiment, the hard molded lozenge
optionally comprises
about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about 1% (w/w) or
about 0.1%
(w/w) to about 1% (w/w) of the one or more flavourants. In an embodiment, the
one or more
flavourants are as described above. In an embodiment, the one or more
flavourants are selected
from eucalyptus, peppermint oils and menthol.
[00224] In an embodiment, the hard molded lozenge comprises the composition as
described in
Example 1. In an embodiment, the hard molded lozenge comprises about 0.1%
(w/w) to about
2% (w/w) of a cannabinoid extract; about 95% (w/w) to about 99% of one or more
oligosaccharides; optionally about 0.1(w/w) to about 1%(w/w) of an emulsifying
agent; optionally
about 0.1 to about 1% of a fat/oil; and optionally about 0.1% (w/w) to about
1% (w/w) of a
flavourant. In an embodiment, the cannabinoid extract comprises about 0.1mg to
about 10mg
of THC. In an embodiment, the hard molded lozenge comprises about the hard
molded lozenge
comprises about of the one or more oligosaccharides selected from fructo-
oligosaccharides
(FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-
oligosaccharides,
48
Date Recue/Date Received 2021-08-20

xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family
of
oligosaccharides, and combinations thereof. In an embodiment, the one or more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS). In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9,
about 3 to about 8,
or about 3 to about 5. In an embodiment, the hard molded lozenge comprises
about 0.1 to about
1% of the one or more emulsifying agents selected from gum Arabic, modified
gum Arabic,
lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an embodiment,
the lecithin is soy
lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin. In an embodiment,
the hard molded lozenge comprises about 0.1% (w/w) to about 1% (w/w) of the
one or more oils
and/or fats and the one or more oils and/or fats are as described above. In an
embodiment, the
one or more oils are vegetable oils. In an embodiment, the one or more oils is
fractionated
coconut oil. In an embodiment, the more oils and/or fats comprises about 0.1 %
(w/w) to about
1% (w/w) of the one or more flavourants selected from eucalyptus, peppermint
oils and menthol.
In an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to about
1% (w/w) of
a cannabinoid extract (e.g., cannabis distillate) ; about 95% (w/w) to about
99% of FOS having a
degree of polymerization of about 2 to about 8; optionally about 0.1% (w/w) to
about 1% (w/w) of
soy lecithin; optionally about 0.1% (w/w) to about 1% (w/w) of fractionated
coconut oil; and
optionally about 0.1%(w/w) to about 1% (w/w) of peppermint oil. In an
embodiment, the hard
molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid
extract; about
90% (w/w) to about 99.9% (w/w) of one or more oligosaccharides having a degree
of
polymerization of about 2 to about 9 selected from fructo-oligosaccharides
(FOS), galacto-
oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof; about 0.1 (w/w) to about 0.2% (w/w) of an
emulsifying agent; optionally
about 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats; and
optionally about 0.1%
(w/w) to about 1% (w/w) of a flavourant.
[00225] The Applicant has found that the addition of a plasticizer such as
glycerin provides a
favourable and controllable rate of dissolution and also decreases the
temperature of
solidification and increases moldability of the bulk lozenge product in the
preparation of the hard
molded lozenge dosage forms. Decreasing temperature of the solidification
advantageously
decreases the amount of hydrolysis of the one or more oligosaccharides by
eliminating exposure
to thermal abuse.
[00226] Accordingly, in an embodiment, the hard molded lozenge optionally
further comprises
one or more plasticizers.
[00227] Therefore, the present application also includes a hard molded lozenge
comprising:
49
Date Recue/Date Received 2021-08-20

(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less;
and
(c) one or more plasticizers.
[00228] In an embodiment, the one or more oligosaccharides having a degree of
polymerization
of about 10 or less are as described above.
[00229] In an embodiment, the buccal dosage form is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00230] In an embodiment, the lozenge comprises about 2% (w/w) to about 15%
(w/w), about 2
% (w/w) to about 12% (w/w), about 2% (w/w) to about 10% (w/w), about 2% (w/w)
to about 8%
(w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w),
about 4 % (w/w)
to about 6% (w/w) or about 5% (w/w) of the plasticizer. In an embodiment, the
lozenge comprises
about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 4
% (w/w) to
about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6%
(w/w) or about
5% (w/w) of the one or more plasticizer. In an embodiment, the lozenge
comprises about 5%
(w/w) of the plasticizer.
[00231] In an embodiment, the one or more plasticizers is selected from
glycerin and
polyethylene glycol and combinations thereof. In an embodiment, the one or
more plasticizers
is glycerin.
[00232] In an embodiment, when a plasticer is present, the hard molded lozenge
comprises
about 10% (w/w) to about 97.9% (w/w), about 15% (w/w)to about 97.9% (w/w),
about 20% (w/w)
to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w), about 30% (w/w) to
about 97.9%
(w/w), about 35% (w/w) to about 97.9% (w/w), about 40% (w/w) to about 97.9%
(w/w), about
45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about 97.9% (w/w), about
55% (w/w) to
about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w), about 65% (w/w) to
about 97.9%
(w/w), about 70% (w/w) to about 97.9% (w/w), about 75% (w/w) to about 97.9%
(w/w), about
80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about 97.9% (w/w), about
90% (w/w) to
about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), or about 96% (w/w) to
about 97.9%
(w/w) of one or more oligosaccharides. In an embodiment, the hard molded
lozenge comprises
about 10% (w/w) to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about
20% (w/w) to
about 95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about
90% (w/w),
about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about
25% (w/w) to
about 75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about
50% (w/w),
about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about
45% (w/w) to
about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w) to about
60% (w/w),
about 20% (w/w) to about 50% (w/w), about 10% (w/w) to about 50% (w/w), or
about 10% (w/w)
Date Recue/Date Received 2021-08-20

to about 75% (w/w) of one or more oligosaccharides. In an embodiment, the hard
molded lozenge
comprises about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9%
(w/w), about
95% (w/w) to about 97.9% (w/w), or about 96% (w/w) to about 97.9% (w/w). In an
embodiment,
when a plasticer is present, the hard molded lozenge comprises about 85% (w/w)
to about 97.9%
(w/w), about 90% (w/w) to about 97.9% (w/w), about 92% (w/w) to about 97.9%
(w/w), or about
94% (w/w) to about 96% (w/w) of one or more oligosaccharides. In an
embodiment, when a
plasticer is present, the hard molded lozenge comprises about 92% (w/w) to
about 96% (w/w) of
one or more oligosaccharides.
[00233] Accordingly, the present application includes a hard molded lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) one or more plasticizers.
[00234] In an embodiment, the hard molded lozenge is comprised primarily of
the one or more
oligosaccharides. In an embodiment, the hard molded lozenge comprises more
than about 70%
of the one or more oligosaccharides having a degree of polymerization of about
10 or less.
[00235] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 70% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) one or more plasticizers.
[00236] In an embodiment, the hard molded lozenge comprises about 75% (w/w) to
about 97.9%
(w/w), about 80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about 97.9%
(w/w), about
90% (w/w) to about 97.9% (w/w), about 92% (w/w) to about 97.9% (w/w), about
95% (w/w) to
about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w), about 97% (w/w) to
about 97.9%
(w/w), about 80% (w/w) to about 96% (w/w), about 80% (w/w) to about 95% (w/w),
about 85%
(w/w) to about 95% (w/w), about 85% (w/w) to about 90% (w/w), about 85% (w/w)
to about 97%
(w/w), about 90% (w/w) to about 96% (w/w), about 90% (w/w) to about 95% (w/w),
about 92%
(w/w) to about 95% (w/w) one or more oligosaccharides. In an embodiment, the
hard molded
lozenge comprises 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about
97.9% (w/w) or
about 95% (w/w) to about 97.9% of one or more oligosaccharides. In an
embodiment, the hard
molded lozenge comprises about 90% (w/w) to about 97.9% (w/w) or about 95%
(w/w) to about
97.9% (w/w) of one or more oligosaccharides.
[00237] In an embodiment, the hard molded lozenge comprises the one or more
oligosaccharides
having a degree of polymerization of about 10 or less as described above. In
an embodiment,
51
Date Recue/Date Received 2021-08-20

the one or more oligosaccharides are selected from digestible oligosaccharides
and non-
digestible oligosaccharides and combinations thereof as described above. In an
embodiment,
the one or more oligosaccharides are one or non-digestible oligosaccharide as
described above.
In an embodiment, the one or more oligosaccharides are selected from fructo-
oligosaccharides
(FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-
oligosaccharides,
xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family
of
oligosaccharides, and combinations thereof. In an embodiment, the one or more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS). In an embodiment, the fructo-oligosaccharide (FOS) is
produced by the
partial enzymatic hydrolysis of inulin from natural sources such as from
chicory, artichoke, yacon,
dahlia, onion, garlic, asparagus, banana or agave. In an embodiment, the FOS
is produced by
the partial enzymatic hydrolysis from chicory inulin. In an embodiment, FOS is
prepared by
enzymatic synthesis with sucrose by methods known in the art, for example, by
the
transfructosylation of sucrose by p-fructofuranosidases. In an embodiment, the
FOS is Orafti
P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
[00238] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the one or more oligosaccharides have degree of polymerization of
about 9 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
8 or less. In an embodiment, the one or more oligosaccharides have a degree of
polymerization
of about 2 to about 10 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 9 or less. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 8 or
less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 10. In an embodiment, the one or more oligosaccharides have a degree of
polymerization
of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to
about 6, about 2 to about
5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to
about 7, about 3 to
about 6, or about 3 to about 5. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to
about 9, about 3
to about 8, or about 3 to about 5. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to
about 8 or about 3
to about 8. In an embodiment, the one or more oligosaccharides have a degree
of polymerization
of about 2 to about 9. In an embodiment, the one or more oligosaccharides have
a degree of
polymerization of about 2 to about 8. In an embodiment, the one or more
oligosaccharides have
a degree of polymerization of about 3 to about 10. In an embodiment, the one
or more
oligosaccharides have a degree of polymerization about 3 to about 9, about 3
to about 8, about
3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the
one or more
52
Date Recue/Date Received 2021-08-20

oligosaccharides have a degree of polymerization of about 3 to about 9, about
3 to about 8, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment,
the one or more
oligosaccharides have a degree of polymerization of about 3 to about 9. In an
embodiment, the
one or more oligosaccharides have a degree of polymerization of about 3 to
about 8.
[00239] In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides. In an
embodiment, the fructo-oligosaccharides has a degree of polymerization of
about 10 or less,
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the fructo-oligosaccharides has degree of polymerization of about
10 or less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 8 or
less. In an embodiment, the fructo-oligosaccharides has a degree of
polymerization of about 9
or less. In an embodiment, the fructo-oligosaccharides has a degree of
polymerization of about
8 or less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 10 or less. In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 2 to about 8 or less. In an embodiment, the fructo-
oligosaccharide has
a degree of polymerization of about 2 to about 10. In an embodiment, the
fructo-oligosaccharides
has a degree of polymerization of about 2 to about 9, about 2 to about 8,
about 2 to about 7,
about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about
9, about 3 to about
8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an
embodiment, the fructo-
oligosaccharide has a degree of polymerization of about 2 to about 9, about 2
to about 8, about
3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
fructo-
oligosaccharides has a degree of polymerization of about 2 to about 9, about 3
to about 9, about
2 to about 8 or about 3 to about 8. In an embodiment, the fructo-
oligosaccharide has a degree
of polymerization of about 2 to about 9. In an embodiment, the fructo-
oligosaccharide has a
degree of polymerization of about 2 to about 8. In an embodiment, the fructo-
oligosaccharide has
a degree of polymerization of about 3 to about 10. In an embodiment, the
fructo-oligosaccharide
has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3
to about 7, about
3 to about 6, or about 3 to about 5. In an embodiment, the fructo-
oligosaccharide has a degree
of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to
about 5. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 9, or
about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree
of polymerization
of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 3 to about 8.
[00240] For the purposes of this application, fructo-oligosaccharide is
considered to include
inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the
oligosaccharide is
fructo-oligosaccharide having a DP of 2). Therefore, when inulobiose is
considered to be an
oligosaccharide, fructo-oligosaccharide having a DP of, for example, 10 or
less which comprises
inulobiose as a natural component is fructo-oligosaccharide having a DP of
about 2 to about 10
53
Date Recue/Date Received 2021-08-20

or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about
8) wherein the
inulobiose occurring as a natural component of the fructo-oligosaccharide is
an oligosaccharide
having a DP of 2. Further, when inulobiose is considered to be
oligosaccharide, fructo-
oligosaccharide having a DP of, for example, 10 or less which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
(such as about
2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a
heterogenous mixture
of oligosaccharides of different DPs of about 2 to about 10 or less including
inulobiose and
comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) not including
inulobiose.
[00241] It would be appreciated by a person skilled in the art, that when
inulobiose is considered
to be a sugar, then the same fructo-oligosaccharide having a DP of, for
example, 10 or less which
comprises inulobiose as a natural component described above is fructo-
oligosaccharide having
a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to
about 9 or about 3
to about 8) wherein the inulobiose occurring as a natural component of the
fructo-oligosaccharide
is included as a component of the naturally occurring sugars in the fructo-
oligosaccharide.
Accordingly, when inulobiose is considered to be a sugar, then fructo-
oligosaccharide having a
DP of, for example, 10 or less comprising inulobiose as a natural component is
fructo-
oligosaccharide having a DP of about 3 to about 10 or less which comprises a
heterogenous
mixture of oligosaccharides of different DPs of about 3 to about 10 or less
not including inulobiose
and comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) including
inulobiose.
[00242] In an embodiment, the fructo-oligosaccharide having a DP of, for
example, 10 or less
comprising inulobiose as a natural component comprises about 0.1 % (w/w) to
about 8% (w/w),
about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 %
(w/w) to about
7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7%
(w/w), about 0.1
% (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 %
(w/w) to about 6%
(w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5%
(w/w), about 1 %
(w/w) to about 5% (w/w), about 0.1 % (w/w) to about 4% (w/w), about 0.5 %
(w/w) to about 4%
(w/w), about 1 % (w/w) to about 4% (w/w), about 0.5 % (w/w) to about 3% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an
embodiment, the fructo-oligosaccharide having a DP of, for example, 10 or less
comprising
inulobiose as a natural component comprises about 1 % (w/w) to about 4%(w/w),
about 1 %
(w/w) to about 3 (w/w), about 1.5 % (w/w) to about 3%(w/w), about 2 % (w/w) to
about 3% (w/w),
of inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide.
[00243] In an embodiment, when inulobiose is defined as a fibre, the fructo-
oligosaccharide
having a DP of, for example, about 10 or less or, for example, a DP of about 2
to about 10 or
less, comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5%
(w/w) of
54
Date Recue/Date Received 2021-08-20

monosaccharides and/or disaccharides on a dry solid basis of the total weight
of the fructo-
oligosaccharide. In an embodiment, when inulobiose is defined as a sugar, the
fructo-
oligosaccharide having a DP of, for example, about 10 or less or, for example,
a DP of about 3
to about 10 or less, comprises about 1% (w/w) to about 8% (w/w) or 1% (w/w) to
about 10%
(w/w) of monosaccharides and/or disaccharides on a dry solid basis of the
total weight of the
fructo-oligosaccharide.
[00244] In an embodiment, the hard molded lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00245] It would be appreciated by a person skilled in the art that the hard
molded lozenges of
the application may comprise residual water resulting from the manufacturing
process. In an
embodiment, the buccal dosage form comprises than about 5% (w/w) or less,
about 4% (w/w) or
less, about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or
about 0.5% (w/w)
or less water on a total weight of the hard molded lozenge basis. In an
embodiment, the buccal
dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1%
(w/w) or less,
or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge
basis.
[00246] In an embodiment, the hard molded lozenge comprises about 2 % (w/w) to
about 10%
(w/w), about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w)
of
monosaccharides and disaccharides on a total weight of the hard molded lozenge
basis. In an
embodiment, the hard molded lozenge comprises about 2 % (w/w) to about 7%
(w/w) or about 2
% (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total
weight of the hard
molded lozenge basis. In an embodiment, the monosaccharides and disaccharides
are present
as a natural component of the one or more oligosaccharides and/or formed as a
by-product of
the manufacturing process.
[00247] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts as described above. In an
embodiment,
the one or more cannabinoid extracts is a cannabinoid distillate. In an
embodiment, the one or
more cannabinoids is selected from THC and CBD and combinations thereof and
combinations
thereof. In an embodiment, the one or more cannabinoids is THC.
[00248] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides.
[00249] In an embodiment, the hard molded lozenge comprises 0.1% (w/w) to
about 3% (w/w),
about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one
or more
Date Recue/Date Received 2021-08-20

cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
hard molded
lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or 0.1%
(w/w) to about 1% (w/w) of a cannabinoid extract. In an embodiment, the hard
molded lozenge
comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or
0.1% (w/w) to
about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
[00250] In an embodiment, the hard molded lozenge of the application can be
used to administer
any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoid
extract may be
in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg,
about 0.1mg to
about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg,
about 0.1 mg to
about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about
0.1 mg to
about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is or comprises THC and typical doses of THC may be in the
range of about
0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15
mg, about 0.1
mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg,
about 0.1 mg to
about 2 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids
and/or cannabinoid extract is THC and typical doses of THC may be in the range
of about 0.1
mg to about 10 mg. In an embodiment, the one or more cannabinoids and/or
cannabinoid extract
is or comprises THC and typical doses of THC may be about 10mg, about 5 mg,
about 2.5 mg,
about 2 mg, about 1mg, about 0.5 mg or about 0.1mg. In an embodiment, the one
or more
cannabinoids and/or cannabinoid extract is or comprises THC and typical doses
of THC may be
about 10mg, about 5mg, about 2.5 mg, or about 0.1mg. In an embodiment, the one
or more
cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be
in the range
of about 0.1 mg to about 500 mg, about 0.1mg to about 400 mg, about 0.1 mg to
about 300 mg,
about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to
about 100mg,
about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to
about 10 mg, about
0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1
mg. In an
embodiment, the one or more cannabinoids and/or cannabinoid extract is or
comprises CBD and
typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5
mg, about 1 mg
or about 0.1 mg. In an embodiment the hard molded lozenge comprises more than
one
cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a
combination of
the suitable doses of each of the cannabinoid and/or cannabinoid extract. In
an embodiment, the
hard molded lozenge comprises THC and CBD, and the buccal dosage form
comprises a
combination of the suitable doses of THC and CDB. In an embodiment, the hard
molded lozenge
56
Date Recue/Date Received 2021-08-20

comprises 10mg of THC and 2mg of CBD. In an embodiment, the hard molded
lozenge
comprises equal amounts of THC and CBD. In an embodiment, the hard molded
lozenge
comprises 5mg of THC and 5mg of CBD. In an embodiment, the hard molded lozenge
comprises
2.5mg of THC and 2.5mg of CBD.
[00251] In an embodiment, the cannabinoid extract is purified such that one or
more cannabinoid
is present at greater than about 80% (w/w), greater than about 85% or greater
than about 95%
of the total extract (w/w). In an embodiment, the hard molded lozenge
comprises about 0.1%
(w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to
about 1% (w/w)
of a cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to
about 20 mg,
about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to
about 5 mg, about
0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or 0.1 mg to about 1 mg of
THC. In an
embodiment, the cannabinoid extract comprises THC of about 0.1 mg to about 10
mg. In an
embodiment, the hard molded lozenge comprises 0.1% (w/w) to about 2% (w/w), or
about 0.1%
(w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract
comprises about
10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1mg, about 0.5 mg or about
0.1mg of THC.
[00252] As the Applicant has prepared a hard molded lozenge comprising a
plasticizer and
comprising about 1% (w/w) of a cannabinoid extract that comprises about 10mg
of THC, the
Applicant has prepared a high potency hard molded lozenge. Therefore, in an
embodiment, the
hard molded lozenge is a high potency hard molded lozenge. Accordingly, in an
embodiment,
the present application includes a high potency hard molded lozenge.
[00253] In an embodiment, the hard molded lozenge optionally further comprises
one or more
polysaccharides. In an embodiment, the one or more polysaccharides have a
degree of
polymerization of up to about 80 and have an average degree of polymerization
of about 9 or
greater. In an embodiment, when present the added % (w/w) of the one or more
polysaccharides
replaces an equal % (w/w) of the one or more oligosaccharides in the buccal
dosage form.
[00254] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more oligosaccharides having a degree of polymerization of about 10
or less,
(c) one or more oligosaccharides having a degree of polymerization up to about
80 and
having an average degree of polymerization of about 9 or greater; and
(d) one or more plasticizers.
1[00255] In an embodiment, when one or more polysaccharides and plasticers are
present, the hard molded lozenge comprises about 10% (w/w) to about 97.8%
(w/w),
about 15% (w/w) to about 97.8% (w/w), about 20% (w/w) to about 97.8% (w/w),
about
25% (w/w) to about 97.8% (w/w), about 30% (w/w) to about 97.8% (w/w), about
35%
57
Date Recue/Date Received 2021-08-20

(w/w) to about 97.8% (w/w), about 40% (w/w) to about 97.8% (w/w), about 45%
(w/w)
to about 97.8% (w/w), about 50% (w/w) to about 97.8% (w/w), about 55% (w/w) to
about
97.8% (w/w), about 60% (w/w) to about 97.8% (w/w), about 65% (w/w) to about
97.8%
(w/w), about 70% (w/w) to about 97.8% (w/w), about 75% (w/w) to about 97.8%
(w/w),
about 80% (w/w) to about 97.8% (w/w), about 85% (w/w) to about 97.8% (w/w),
about
90% (w/w) to about 97.8% (w/w), about 95% (w/w) to about 97.8% (w/w), or about
96%
(w/w) to about 97.8% (w/w) of one ore more oligosaccharides. In an embodiment,
when
one or more polysaccharides and plasticers are present, the hard molded
lozenge
comprises about 85% (w/w) to about 97.8% (w/w), about 90% (w/w) to about 97.8%
(w/w), about 95% (w/w) to about 97.8% (w/w), or about 96% (w/w) to about 97.8%
(w/w)
of one or more oligosaccharides. In an embodiment, when a plasticer is
present, the
hard molded lozenge comprises about 85% (w/w) to about 97.8% (w/w), about 90%
(w/w) to about 97.8% (w/w), about 92% (w/w) to about 97.8% (w/w), or about 94%
(w/w)
to about 96% (w/w) of one or more oligosaccharides.
[00256] In an embodiment, when one or more plasticers are present, the hard
molded
lozenge comprises about 0.1% (w/w) to about 87.9% (w/w), about 0.5% (w/w) to
about
87.9% (w/w), about 1% (w/w) to about 87.9% (w/w), about 5% (w/w) to about
87.9%
(w/w), about 10% (w/w) to about 87.9%(w/w), about 15% (w/w) to about 87.9%
(w/w),
about 20% (w/w) to about 87.9% (w/w), about 25% (w/w) to about 87.9%(w/w),
about
30% (w/w) to about 87.9% (w/w), about 35% (w/w) to about 87.9% (w/w), about
40%
(w/w) to about 87.9%(w/w), about 45% (w/w) to about 87.9% (w/w), about 50%
(w/w) to
about 87.9% (w/w), about 55% (w/w) to about 87.9%(w/w), about 60% (w/w), about
87.9% (w/w), about 65% (w/w) to about 87.9% (w/w), about 70% (w/w) to about
87.9%(w/w), about 75% (w/w) to about 87.9% (w/w), about 80% (w/w), about 87.9%
(w/w), or about 85% (w/w), about 87.9% (w/w) of one or more polysaccharides.
In an
embodiment, when one or more plasticers are present, the hard molded lozenge
comprises about 0.1% (w/w) to about 87.9% (w/w), about 0.1% (w/w) to about 80%
(w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 50%
(w/w),
about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70% (w/w),
about 5%
(w/w) to about 50% (w/w), about 10% (w/w) to about 70%(w/w), about 15% (w/w)
to
about 60% (w/w), about 20% (w/w) to about 74% (w/w), about 25% (w/w) to about
75%(w/w), about 25% (w/w) to about 75% (w/w), 0.1% (w/w) to about 74% (w/w),
about
40% (w/w) to about 70% (w/w), about 10% (w/w) to about 30%(w/w), about 15%
(w/w)
to about 25% (w/w), about 50% (w/w) to about 75% (w/w), about 50% (w/w) to
about
74% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80%
(w/w),
58
Date Recue/Date Received 2021-08-20

about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about
30%
(w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), 40% (w/w) to
about
60% (w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55%
(w/w),
about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about 50% (w/w), about
10%
(w/w) to about 50% (w/w), or about 10% (w/w) to about 75% (w/w) of the one or
more
polysaccharides.
[00257] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 97.8 % (w/w) of the
hard molded
lozenge. In an embodiment, when a plasticer is present, the one or more
oligosaccharides and
the one or more polysaccharides comprise about 55% (w/w) to about 97.8% (w/w)
of the hard
molded lozenge.
[00258] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 60% (w/w) to about 97.8 % (w/w), about
65% (w/w)
to about 97.8 % (w/w), about 70% (w/w) to about 97.8 % (w/w), about 75% (w/w)
to about 97.8
% (w/w), about 80% (w/w) to about 97.8 % (w/w), about 85% (w/w) to about 97.8
% (w/w), about
90% (w/w) to about 97.8 % (w/w), about 95% (w/w) to about 97.8 % (w/w), about
90% (w/w) to
about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about
96% (w/w),
about 90% (w/w) to about 95% (w/w), about 90% (w/w) to about 94% (w/w) or
about 90% (w/w)
to about 93% (w/w) of the hard molded lozenge.
[00259] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 60% (w/w) to about 97.8% (w/w), about
65% (w/w) to
about 97.8% (w/w), about 70% (w/w) to about 97.8% (w/w), about 75% (w/w) to
about 97.8%
(w/w), about 80% (w/w) to about 97.8% (w/w), about 85% (w/w) to about 97.8%
(w/w), ), about
90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90%
(w/w) to about
96% (w/w), about 90% (w/w) to about 95% (w/w), about 90% (w/w) to about 97.8%
(w/w), about
95% (w/w) to about 97.8% (w/w), about 97% (w/w) to about 97.8% (w/w),of the
hard molded
lozenge.
[00260] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
[00261] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00262] In an embodiment, the one or more polysaccharides are as described
above. In an
embodiment, the one or more polysaccharides is inulin. Accordingly, in an
embodiment, the hard
59
Date Recue/Date Received 2021-08-20

molded lozenge comprises about 0.1% (w/w) to about 87.9% (w/w) of inulin
having a degree of
polymerization of up to 60 and having an average degree of polymerization of
about 9 or greater.
In another embodiment, the hard molded lozenge comprises about 0.1% (w/w) to
about 87.9%
(w/w) of inulin having a degree of polymerization of up to 60 and having an
average degree of
polymerization of about 9 or greater, wherein the one or more oligosaccharides
and the inulin
combined comprise about 55% (w/w) to about 97.9% (w/w) of the hard molded
lozenge.
[00263] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a
degree of
polymerization of about 3 to about 60, or about 10 to about 60. In an
embodiment, the inulin has
a degree of polymerization of about 10 to about 60. In an embodiment, the
inulin has an average
degree of polymerization of about 10 or greater. In an embodiment, the inulin
is Orafti inulin by
Beneo Inc. (New Jersey, USA).
[00264] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides
[00265] In an embodiment, the lozenge optionally further comprises one or more
additives
selected from emulsifying agents, oils and/or fats, plasticizers, flavourants,
gelling agents, pH
controlling agents, and lubricants as described above.
[00266] Accordingly, the present application includes a hard molded lozenge
comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 2% (w/w) to about 15% (w/w) of one or more plasticizers, and
(d) optionally about 0.1% (w/w) to about 3% (w/w) or less of one or more
emulsifying
agents.
[00267] In an embodiment, the present application includes a lozenge
comprising:
(a) about 0.1 % (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 70% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 2% (w/w) to about 10% (w/w) one or more plasticizers, and
Date Recue/Date Received 2021-08-20

(d) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[00268] The present application also includes a lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.8% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 87.9% (w/w) of one or more polysaccharides
having a
degree of polymerization of up to about 80 and having an average degree of
polymerization of about 9 or greater;
(d) about 2% (w/w) to about 10% (w/w) one or more plasticizers, and
(e) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[00269] In an embodiment, the present application also includes a lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 25% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 74% (w/w) of one or more polysaccharides having
a degree
of polymerization up to about 80 and having an average degree of
polymerization of
about 9 or greater;
(d) about 2% (w/w) to about 10% (w/w) of one or more plasticizers, and
(d) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[00270] In an embodiment, the hard molded lozenge comprises the one or more
oligosaccharides
having a degree of polymerization of about 10 or less as described above. In
an embodiment,
the hard molded lozenge comprises one or more polysaccharides having a degree
of
polymerization up to about 80 and having an average degree of polymerization
of about 9 or
greater as described above.
[00271] In an embodiment, the lozenge comprises about 2 % (w/w) to about 8%
(w/w), about 4
% (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w)
to about 6%
(w/w) or about 5% (w/w) of the one or more plasticizers. In an embodiment, the
lozenge
comprises about 5% (w/w) of the one or more plasticizers. In an embodiment,
the one or more
plasticizers is glycerin.
[00272] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
or about 1 % (w/w) or less of one or more emulsifying agents as described
above. In an
embodiment, the hard molded lozenge further comprises about 0.1% (w/w) to
about 2% (w/w),
about 0.1 % (w/w) to about 1 % (w/w), about 0.1 % (w/w) to about 0.5 % (w/w),
about 0.5 % (w/w)
to about 1 % (w/w) or about 0.5 % (w/w) to about 2 % (w/w) of one or more
emulsifying agents
61
Date Recue/Date Received 2021-08-20

as described above. In an embodiment, the hard molded lozenge further
comprises about 0.5
% (w/w) or less, about 1 %( w/w) or less of the one or more emulsifying agent
as described above.
In an embodiment, the hard molded lozenge optionally comprises about 0.1%
(w/w) or less, about
0.2%(w/w) or less, about 0.3% (w/w) or less, about OA% (w/w) or less, about
0.5% (w/w) or less,
about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more
emulsifying agents. In
an embodiment, the hard molded lozenge optionally comprises about 0.5% (w/w)
or less of the
one or more emulsifying agents.
[00273] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more emulsifying agents are selected from gum Arabic,
modified gum
Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an
embodiment, the lecithin is
soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin.
[00274] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more oils and/or fats. In an embodiment, the hard molded lozenge
comprises about
1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the
hard molded lozenge
further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to
about 1.5% (w/w),
about 0.1 % (w/w) to about 1 % (w/w), about 0.5 % (w/w) to about 1 % (w/w),
about 0.5 % (w/w)
to about 2 % (w/w) or about 0.1 % (w/w) to about 0.5 % (w/w) of one or more
oils and/or fats
as described above. In an embodiment, the one or more oils and/or fats are as
described above.
In an embodiment, the one or more oils are vegetable oils. In an embodiment,
the hard molded
lozenge does not comprise a fat.
[00275] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from flavourants, and pH controlling agents as described
above.
[00276] In an embodiment, the hard molded lozenge optionally comprises about
1%(w/w) or less
of the one or more flavourants. In an embodiment, the hard molded lozenge
optionally comprises
about 0.1 % (w/w) to about U.S % (w/w), about 0.5 % (w/w) to about 1 % (w/w),
about 0.5 %
(w/w) to about 2 % (w/w) or about 0.1% (w/w) to about 1% (w/w) of the one or
more flavourants.
In an embodiment, the one or more flavourants are as described above. In an
embodiment, the
one or more flavourants are selected from eucalyptus, peppermint oils and
menthol.
[00277] In an embodiment, the hard molded lozenge comprises
(a) about 0.1% (w/w) to about 1% of one or more cannabinoid and/or cannabinoid
extract;
(b) about 85% (w/w) to 95% (w/w) of one or more oligosaccharides having a
degree of
polymerization of about 10 or less;
(c) about 2 % (w/w) to about 10% (w/w) of one or more plasticizers;
(d) optionally about 0.1 (w/w) to about 1% (w/w) of an emulsifying agent; and
62
Date Recue/Date Received 2021-08-20

(e) optionally about 0.1% (w/w) to about 1% (w/w) of a flavourant.
[00278] In an embodiment, the hard molded lozenge comprises a cannabinoid
extract. In an
embodiment, the hard molded lozenge comprises about 0.1mg to about 10mg of
THC. In an
embodiment, the one or more oligosaccharides are selected from fructo-
oligosaccharides (FOS),
galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-
oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof. In an embodiment, the one or more oligosaccharides
are selected
from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and
combinations
thereof. In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides (FOS).
In an embodiment, the FOS is Orafti P95 Oligofructose from Beneo GmbH New
Jersey, U.S.A.
[00279] In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides. In an
embodiment, the fructo-oligosaccharides has a degree of polymerization of
about 10 or less,
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the fructo-oligosaccharides has degree of polymerization of about
10 or less. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
8 or less. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
9 or less. In an
embodiment, the fructo-oligosaccharides has a degree of polymerization of
about 8 or less. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
2 to about 10 or
less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about 2 to
about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of
about 2 to about 10. In an embodiment, the fructo-oligosaccharide has a degree
of polymerization
of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to
about 6, about 2 to about
5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to
about 7, about 3 to
about 6, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide
has a degree of
polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9,
about 3 to about 8,
or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a
degree of
polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8
or about 3 to about
8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization
of about 2 to
about 9. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of
about 3 to about 10. In an embodiment, the fructo-oligosaccharide has a degree
of polymerization
about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about
6, or about 3 to about
5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization
of about 3 to
about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
fructo-oligosaccharide
has a degree of polymerization of about 3 to about 9, or about 3 to about 8.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 3 to about
9. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 8.
63
Date Recue/Date Received 2021-08-20

[00280] In an embodiment, the hard molded lozenge comprises the compositions
as described
in Example 13. In an embodiment, the hard molded lozenge comprises about 0.1%
(w/w) to about
2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 96% of one or more
oligosaccharides; about 3 % (w/w) to about 6% (w/w) of the one or more
plasticizers; optionally
about 0.1 % (w/w) to about 0.5% (w/w) of an emulsifying agent; and optionally
about 0.1 % (w/w)
to about 1% (w/w) of a flavourant. In an embodiment, the cannabinoid extract
comprises about
0.1mg to about 10mg of THC. In an embodiment, the cannabinoid extract
comprises about 10mg
of THC. In an embodiment, the hard molded lozenge comprises about 90% (w/w) to
about 96%
(w/w) of one or more oligosaccharides selected from fructo-oligosaccharides
(FOS), galacto-
oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof. In an embodiment, the one or more oligosaccharides
are selected
from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and
combinations
thereof. In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides (FOS).
In an embodiment, the fructo-oligosaccharide has a degree of polymerization of
about 2 to about
9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to
about 5. In an
embodiment, the hard molded lozenge comprises about 0.1 to about 0.5 of the
one or more
emulsifying agents selected from gum Arabic, modified gum Arabic, lecithins,
hydroxylated
lecithin, and hydrolyzed lecithin. In an embodiment, the one or more
emulsifying agents is
lecithin. In an embodiment, the hard molded lozenge comprises about 0.1%(
(w/w) to about
1%(w/w) of the one or more flavourants selected from eucalyptus, peppermint
oils and menthol.
In an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to about
2% (w/w) of
a cannabinoid extract (e.g., cannabis distillate) ; about 90% (w/w) to about
96% of FOS having a
degree of polymerization of about 2 to about 8; about 3% (w/w) to about 6% of
glycerin; optionally
about 0.1 % (w/w) to about 0.5% (w/w) of lecithin, and optionally about 0.1%
(w/w) to about 1%
(w/w) of peppermint oil. In an embodiment, the hard molded lozenge comprises
about 0.1%
(w/w) to about 2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 96%
(w/w) of one
or more oligosaccharides having a degree of polymerization of about 2 to about
9 selected from
fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides,
manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides
(IMO), and raffinose
family of oligosaccharides, and combinations thereof; about 3 % (w/w) to about
6% (w/w) of
glycerin; optionally about 0.1 % (w/w) to about 0.5% (w/w) of an emulsifying
agent; and optionally
about 0.1 % (w/w) to about 1% (w/w) of a flavourant.
[00281] In an embodiment, the hard molded lozenge comprises the compositions
as described
in Example 21. In an embodiment, the hard molded lozenge comprises about 0.1%
(w/w) to
about 2% (w/w) of a cannabinoid extract; about 40% (w/w) to about 60% of one
or more
oligosaccharides; about 40% (w/w) to about 60% of one or more polysaccharides;
about 3 %
(w/w) to about 6% (w/w) of the one or more plasticizers; optionally about 0.1
% (w/w) to about
64
Date Recue/Date Received 2021-08-20

0.5% (w/w) of an emulsifying agent; and optionally about 0.1 % (w/w) to about
1 % (w/w) of a
flavourant. In an embodiment, the cannabinoid extract comprises about 0.1mg to
about 10mg of
THC. In an embodiment, the cannabinoid extract comprises about 10mg of THC. In
an
embodiment, the hard molded lozenge comprises about 40% (w/w) to about 50 %
(w/w) of one
or more oligosaccharides selected from fructo-oligosaccharides (FOS), galacto-
oligosaccharides
(GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-
oligosaccharides (IMO), and raffinose family of oligosaccharides, and
combinations thereof. In
an embodiment, the one or more oligosaccharides are selected from fructo-
oligosaccharides
(FOS), and galacto-oligosaccharides (GOS) and combinations thereof. In an
embodiment, the
one or more oligosaccharides is fructo-oligosaccharides (FOS). In an
embodiment, the fructo-
oligosaccharide has a degree of polymerization of about 2 to about 9, about 2
to about 8, about
3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the
hard molded
lozenge comprises about 40% (w/w) to about 50% of one or more polysaccharides
and the one
or more polysaccharides is inulin having a degree of polymerization of up to
60 and having an
average degree of polymerization of about 9 or greater. In an embodiment, the
hard molded
lozenge comprises about 0.1 % (w/w) to about 0.5% (w/w) of the one or more
emulsifying agents
selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated
lecithin, and hydrolyzed
lecithin. In an embodiment, the one or more emulsifying agents is lecithin. In
an embodiment, the
hard molded lozenge comprises about 0.1 % (w/w) to about 1 % (w/w) of the one
or more
flavourants selected from eucalyptus, peppermint oils and menthol. In an
embodiment, the hard
molded lozenge comprises about 0.1% (w/w) to about 2% (w/w of a cannabinoid
extract (e.g.,
cannabis distillate), about 40% (w/w) to about 60% of FOS having a degree of
about 2 to about
8, about 40% (w/w) to about 60% of inulin having a degree of polymerization of
up to 60 and
having an average degree of polymerization of about 9 or greater or about 10
or greater about
3% (w/w) to about 6% of glycerin, optionally about 0.1% (w/w) to about 0.5%
(w/w) of lecithin,
and optionally about 0.1% (w/w) to about 1% (w/w) of peppermint oil. In an
embodiment, the
one or more oligosaccharides and the one or more polysaccharides combined
comprise about
90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90%
(w/w) to about
96% (w/w) or about 90% (w/w) to about 95% (w/w) of the hard molded lozenge. In
an
embodiment, the hard molded lozenge comprises about 1% to about 2% of a
cannabinoid
extract; about 40% (w/w) to about 60% of one or more oligosaccharides having a
degree of
polymerization of about 2 to about 9 selected from fructo-oligosaccharides
(FOS), galacto-
oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof; about 40% (w/w) to about 60% of inulin having a
degree of
polymerization of up to 60 and having an average degree of polymerization of
about 10 or greater,
about 4 % (w/w) to about 6% (w/w) of glycerin; about 0.1 to about 0.5% of an
emulsifying agent;
and optionally about 0.1 to about 1% of a flavourant, wherein the one or more
oligosaccharides
and the one or more polysaccharides combined comprise about 90% (w/w) to about
98% (w/w),
Date Recue/Date Received 2021-08-20

about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w) of the
hard molded
lozenge.
[00282] In an embodiment, the hard molded lozenge may also comprise further
excipients used
in the formation of buccal dosage forms such as carriers (e.g., lactose or
corn starch) and binding
agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or
hydroxypropyl methylcellulose);
fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate);
disintegrants (e.g., potato
starch, sodium starch glycolate, croscarmellose sodium, and crospovidone); or
wetting agents
(e.g., sodium lauryl sulphate).
[00283] The Applicant has prepared hard molded lozenges comprising one or more
polysaccharides such as inulin and a plasticizer such glycerin.
[00284] Accordingly, the present application also includes a hard molded
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) one or more polysaccharides having a degree of polymerization of up to
about 80
and having an average degree of polymerization of about 9 or greater; and
(c) one or more plasticizers.
[00285] In an embodiment, the hard molded lozenge comprises about 10% (w/w) to
about 97.9%
(w/w) of one or more polysaccharides, about 15% (w/w) to about 97.9% (w/w),
about 20% (w/w)
to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w), about 30% (w/w) to
about 97.9%
(w/w), about 35% (w/w) to about 97.9% (w/w), about 40% (w/w) to about 97.9%
(w/w), about
45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about 97.9% (w/w), about
55% (w/w) to
about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w), about 65% (w/w) to
about 97.9%
(w/w), about 70% (w/w) to about 97.9% (w/w), about 75% (w/w) to about 97.9%
(w/w), about
80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about 97.9% % (w/w), about
90% (w/w) to
about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), about 96% (w/w) to
about 97.9%
(w/w), about 97% (w/w) to about 97.9% (w/w) one or more polysaccharides. In an
embodiment,
the hard molded lozenge comprises about 85% (w/w) to about 97.9% (w/w), about
90% (w/w) to
about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), about 96% (w/w) to
about 97.9%
(w/w), or about 97% (w/w) to about 97.9% (w/w) of the one or more
polysaccharides). In an
embodiment, the hard molded lozenge comprises about 95% (w/w) to about 97.9% %
(w/w) of
the one or more polysaccharides.
[00286] Accordingly, the present application includes a hard molded lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 85% (w/w) to about 97.9% (w/w) of one or more polysaccharides having
a
degree of polymerization of up to about 80 and having an average degree of
polymerization of about 9 or greater; and
66
Date Recue/Date Received 2021-08-20

(c) one or more plasticizers.
[00287] In an embodiment, the lozenge comprises about 2 % (w/w) to about 15%
(w/w), about 2
% (w/w) to about 12% (w/w), about 2 % (w/w) to about 10% (w/w), about 2 %
(w/w) to about 8%
(w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 8% (w/w),
about 3 % (w/w)
to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the
plasticizer. In an
embodiment, the lozenge comprises about 2 % (w/w) to about 10% (w/w), about 2
% (w/w) to
about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 8%
(w/w), about
3% (w/w) to about 6% (w/w), about 4% (w/w) to about 6% (w/w) or about 5% (w/w)
of the one
or more plasticizer. In an embodiment, the lozenge comprises about 5% (w/w) of
the plasticizer.
[00288] In an embodiment, the one or more plasticizers is selected from
glycerin and
polyethylene glycol and combinations thereof. In an embodiment, the one or
more plasticizers
is glycerin.
[00289] It would be appreciated by a person skilled in the art that the hard
molded lozenges of
the application may comprise residual water resulting from the manufacturing
process. In an
embodiment, the buccal dosage form comprises than about 5% (w/w) or less,
about 4% (w/w) or
less, about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or
about 0.5% (w/w)
or less water on a total weight of the hard molded lozenge basis. In an
embodiment, the buccal
dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1%
(w/w) or less,
or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge
basis.
[00290] In an embodiment, the hard molded lozenge comprises about 2 % (w/w) to
about 10%
(w/w), about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w)
of
monosaccharides and disaccharides on a total weight of the hard molded lozenge
basis. In an
embodiment, the hard molded lozenge comprises about 2 % (w/w) to about 7%
(w/w) or about 2
% (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total
weight of the hard
molded lozenge basis. In an embodiment, the monosaccharides and disaccharides
are present
as a natural component of the one or more oligosaccharides and/or formed as a
by-product of
the manufacturing process.
[00291] In an embodiment, the hard molded lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00292] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts are as described above. In
an
embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof and
combinations thereof. In an embodiment, the one or more cannabinoids is THC.
67
Date Recue/Date Received 2021-08-20

[00293] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides.
[00294] In an embodiment, the hard molded lozenge comprises 0.1% (w/w) to
about 3% (w/w),
about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one
or more
cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
hard molded
lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2%
(w/w), or 0.1%
(w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid
extract.
[00295] In an embodiment, the hard molded lozenge of the application can be
used to administer
any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoid
extract may be
in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg,
about 0.1mg to
about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg,
about 0.1 mg to
about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about
0.1 mg to
about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about
0.1 mg to about
mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to
about 2 mg,
or about 0.1 mg to about 1 mg. In an embodiment, the one or more cannabinoids
and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 10 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is
THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg,
about 2 mg, about
1mg, about 0.5 mg or about 0.1mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be about 10mg, about
5mg, about 2.5
mg, or about 0.1mg.
[00296] In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is CBD and
typical doses of CBD may be in the range of about 0.1 mg to about 500 mg,
about 0.1mg to about
400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1
mg to about
200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg
to about 25
mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to
about 2.5 mg, or
about 0.1 mg to about 1 mg. In an embodiment, the one or more cannabinoids
and/or
68
Date Recue/Date Received 2021-08-20

cannabinoid extract is CBD and typical doses of CBD may be in the range of
about 10mg, about
mg, about 2.5 mg, about 1 mg or about 0.1 mg. In an embodiment the hard molded
lozenge
comprises more than one cannabinoid and/or cannabinoid extract and the buccal
dosage form
comprises a combination of the suitable doses of each of the cannabinoid
and/or cannabinoid
extract. In an embodiment the hard molded lozenge comprises THC and CBD, and
the buccal
dosage form comprises a combination of the suitable doses of THC and CDB. In
an embodiment,
the hard molded lozenge comprises 10mg of THC and 2mg of CBD. In an
embodiment, the hard
molded lozenge comprises equal amounts of THC and CBD. In an embodiment, the
hard molded
lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the hard molded
lozenge
comprises 2.5mg of THC and 2.5mg of CBD.
[00297] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
[00298] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00299] In an embodiment, the one or more polysaccharides are selected from
the
polysaccharides described above. In an embodiment, the one or more
polysaccharides is inulin.
Accordingly, in an embodiment, the buccal dosage form comprises about 0.1%
(w/w) to about
97.9% (w/w) of inulin having a degree of polymerization of up to 60 and having
an average degree
of polymerization of about 9 or greater.
[00300] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a
degree of
polymerization of about 3 to about 60, or about 10 to about 60. In an
embodiment, the inulin has
a degree of polymerization of about 10 to about 60. In an embodiment, the
inulin has an average
degree of polymerization of about 10 or greater. In an embodiment, the inulin
is Orafti inulin by
Beneo Inc. (New Jersey, USA).
[00301] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from, emulsifying agents, oils and/or fats, flavourants,
and pH modifying
agents as described above.
[00302] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more emulsifying agents are selected from gum Arabic,
modified gum
Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an
embodiment, the lecithin is
soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin.
69
Date Recue/Date Received 2021-08-20

[00303] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more oils and/or fats. In an embodiment, the hard molded lozenge
comprises about
1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the
hard molded lozenge
further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to
about 1.5% (w/w),
about 0.5% (w/w) to about 1%(w/w) or about 0.1 % (w/w) to about 1 % (w/w) of
one or more oils
and/or fats as described above. In an embodiment, the one or more oils and/or
fats are as
described above. In an embodiment, the one or more oils are vegetable oils. In
an embodiment,
the hard molded lozenge does not comprise a fat.
[00304] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from flavourants, and pH controlling agents as described
above.
[00305] In an embodiment, the hard molded lozenge optionally comprises about
1%(w/w) or less
of the one or more flavourants. In an embodiment, the hard molded lozenge
optionally comprises
about 0.1% (w/w) to about 1% (w/w) or about 0.5% (w/w) to about 1%(w/w) of the
one or more
flavourants. In an embodiment, the one or more flavourants are as described
above. In an
embodiment, the one or more flavourants are selected from eucalyptus,
peppermint oils and
menthol.
[00306] In an embodiment, the hard molded lozenge comprises the one or more
cannabinoids,
and/or a cannabinoid extract as described above. In an embodiment, the present
application also
includes a hard molded lozenge comprising the one or more cannabinoids as
described above.
In an embodiment, the present application also includes a hard molded lozenge
comprising the
one or more cannabinoid extracts as described above. In an embodiment, the one
or more
cannabinoid extracts is a cannabinoid distillate. In an embodiment, the one or
more cannabinoids
is selected from THC and CBD and combinations thereof. In an embodiment, the
one or more
cannabinoids is THC.
[00307] Accordingly, the present application includes a hard molded lozenge
comprising:
(a) about 0.1% (w/w) to about 2% of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 85% (w/w) to about 97.9% (w/w) of one or more one or more
polysaccharides
having a degree of polymerization of up to about 80 and having an average
degree of
polymerization of about 9 or greater;
(c) about 2% (w/w) to about 15% (w/w) of one or more plasticizers, and
(d) optionally about 0.1 (w/w) to about 3% (w/w) of one or more emulsifying
agents.
[00308] In an embodiment, the lozenge comprises about 2 % (w/w) to about 8%
(w/w), about 4
% (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w)
to about 6%
(w/w) or about 5% (w/w) of the one or more plasticizer. In an embodiment, the
lozenge comprises
about 5% (w/w) of the plasticizer. In an embodiment, the one or more
plasticizers is glycerin.
Date Recue/Date Received 2021-08-20

[00309] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more emulsifying agents as described above. In an embodiment, the
hard molded
lozenge further comprises about 1%( w/w) or less of the one or more
emulsifying agent as
described above. In an embodiment, the hard molded lozenge further comprises
about 0.1%
(w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5%
(w/w) to about
1%(w/w), or about 0.1 % (w/w) to about 1 % (w/w) of one or more emulsifying
agents as described
above. In an embodiment, the hard molded lozenge optionally comprises about
0.1% (w/w) or
less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about OA% (w/w) or
less, about 0.5%
(w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the
one or more emulsifying
agents. In an embodiment, the hard molded lozenge optionally comprises about
0.5% (w/w) to
about 1%(w/w) or about 0.5% (w/w) or less of the one or more emulsifying
agents.
[00310] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more emulsifying agents are selected from gum Arabic,
modified gum
Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an
embodiment, the lecithin is
soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin.
[00311] In an embodiment, the hard molded lozenge further comprises about 2%
(w/w) or less
of one or more oils and/or fats. In an embodiment, the hard molded lozenge
comprises about
1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the
hard molded lozenge
comprises about 0.1 % (w/w) to about 2 % (w/w), about 0.5% (w/w) to about
1%(w/w) or about
0.1 % (w/w) to about 1 % (w/w) of one or more oils and/or fats as described
above.
[00312] In an embodiment, the one or more oils and/or fats are as described
above. In an
embodiment, the one or more oils are vegetable oils. In an embodiment, the
hard molded lozenge
does not comprise a fat.
[00313] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from flavourants, and pH controlling agents as described
above.
[00314] In an embodiment, the hard molded lozenge optionally comprises about
1%(w/w) or less
of the one or more flavourants. In an embodiment, the one or more flavourants
are as described
above. In an embodiment, the one or more flavourants are selected from
eucalyptus, peppermint
oils and menthol. The Applicant has prepared hard molded lozenges comprising
one or more
polysaccharides such as inulin and a plasticizer such glycerin. In an
embodiment, the buccal
dosage forms have been prepared without any added sugars, sweeteners, or
sweetening agents.
[00315] In an embodiment, the hard molded lozenge comprises the composition as
described in
Example 20. In an embodiment, the hard molded lozenge comprises about 0.1%
(w/w) to about
2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 95% (w/w) of one
or more
polysaccharides; about 3 % (w/w) to about 6% (w/w) of the one or more
plasticizers; optionally
about 0.1 % (w/w) to about 0.5% (w/w)of an emulsifying agent; and optionally
about 0.1 % (w/w)
to about 1% (w/w) of a flavourant. In an embodiment, the cannabinoid extract
comprises about
71
Date Recue/Date Received 2021-08-20

0.1mg to about 10mg of THC. In an embodiment, the cannabinoid extract
comprises about 10mg
of THC. In an embodiment, the hard molded lozenge comprises about 90% (w/w) to
about 95%
(w/w) of one or more polysaccharides wherein the one or more polysaccharides
is inulin having
a degree of polymerization of up to 60 and having an average degree of
polymerization of about
9 or greater or about 10 or greater. In an embodiment, the hard molded lozenge
comprises about
0.1 % (w/w) to about 0.5% (w/w) of the one or more emulsifying agents selected
from gum Arabic,
modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed
lecithin. In an embodiment,
the one or more emulsifying agents is lecithin. In an embodiment, the hard
molded lozenge
comprises about 0.1 % (w/w) to about 1% (w/w) of the one or more flavourants
selected from
eucalyptus, peppermint oils and menthol. In an embodiment, the hard molded
lozenge comprises
about 1% (w/w) of a cannabinoid extract (e.g., cannabis distillate) ; about
90% (w/w) to about
95% (w/w) of inulin having a degree of polymerization of up to 60 and having
an average degree
of polymerization of about 9 or greater; about 3% (w/w) to about 6% (w/w) of
glycerin; optionally
about 0.1 (w/w) to about 0.5% (w/w)of lecithin; and optionally about 0.1
%(w/w) to about 1%
(w/w) of peppermint oil.
Soft Chew Lozenges
[00316] The Applicant has prepared soft chew lozenges comprising one or more
oligosaccharides such as fructo-oligosaccharides.
[00317] Accordingly, in an embodiment, the present application also includes a
soft chew lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or less; and
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents.
[00318] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) to about
70% (w/w), about 10% (w/w) to about 70% (w/w), about 10% (w/w) to about 65%
(w/w), about
10% (w/w) to about 60% (w/w), about 10% (w/w) to about 55% (w/w), about 10%
(w/w) to about
55% (w/w), about 10% (w/w) to about 50% (w/w), about 10% (w/w) to about 45%
(w/w) water,
about 10% (w/w) to about 40% (w/w) water about 10% (w/w) to about 35% (w/w)
water, about
10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water,
or about 10%
(w/w) to about 20% (w/w) water In an embodiment, the soft chew lozenge further
comprises
about 10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w)
water, or about
10% (w/w) to about 20% (w/w) water.
[00319] In an embodiment, the present application includes a soft chew lozenge
comprising the
one or more cannabinoids, and/or a cannabinoid extract as described above. In
an embodiment,
the present application also includes a soft chew lozenge comprising the one
or more
72
Date Recue/Date Received 2021-08-20

cannabinoids as described above. In an embodiment, the present application
also includes a soft
chew lozenge comprising the one or more cannabinoid extracts as described
above. In an
embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof. In an
embodiment, the one or more cannabinoids is THC.
[00320] In an embodiment, the soft chew lozenge comprises about 0.1% (w/w) to
about 3%
(w/w), about 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1%
(w/w) of the one or
more cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
soft chew
lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to
about 2% (w/w),
or about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or
a cannabinoid
extract.
[00321] In an embodiment, the soft chew lozenge of the application can be used
to administer
any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoid
extract may be
in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg,
about 0.1mg to
about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg,
about 0.1 mg to
about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about
0.1 mg to
about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about
0.1 mg to about
mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to
about 2 mg,
or about 0.1 mg to about 1 mg. In an embodiment, the one or more cannabinoids
and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 10 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is
THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg,
about 2 mg, about
1mg, about 0.5 mg or about 0.1mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be about 10mg, about
5mg, about 2.5
mg, or about 0.1mg. In an embodiment, the one or more cannabinoids and/or
cannabinoid extract
is CBD and typical doses of CBD may be in the range of about 0.1 mg to about
500 mg, about
0.1mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250
mg, about 0.1
mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg,
about 0.1 mg
to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is CBD and typical doses of CBD may be in the range of
about 10mg, about
73
Date Recue/Date Received 2021-08-20

mg, about 2.5 mg, about 1 mg or about 0.1 mg. In an embodiment the soft chew
lozenge
comprises more than one cannabinoid and/or cannabinoid extract and the buccal
dosage form
comprises a combination of the suitable doses of each of the cannabinoid
and/or cannabinoid
extract. In an embodiment the soft chew lozenge comprises THC and CBD, and the
buccal
dosage form comprises a combination of the suitable doses of THC and CDB. In
an embodiment,
the soft chew lozenge comprises 10mg of THC and 2mg of CBD. In an embodiment,
the soft
chew lozenge comprises equal amounts of THC and CBD. In an embodiment, the
soft chew
lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the soft chew
lozenge
comprises 2.5mg of THC and 2.5mg of CBD.
[00322] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:900 to
about 1:5, about
1:800 to about 1:5, about 1:700 to about 1:5, about 1:600 to about 1:5, about
1:500 to about 1:5,
about 1:400 to about 1:5, about 1:300 to about 1:5, about 1:200 to about 1:5,
about 1:150 to
about 1:5, about 1:100 to about 1:5, about 1:400 to about 1:50, about 1:400 to
about 1:100, about
1:300 to about 1:100, about 1:300, about 1:200, about 1:150 or about 1:100 of
the one or more
cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides
[00323] In an embodiment, the buccal dosage form comprises about 15% (w/w) to
about 90%
(w/w) of one or more oligosaccharides, about 20% (w/w) to about 90% (w/w) of
one or more
oligosaccharides, about 25% (w/w) to about 90% (w/w) of one or more
oligosaccharides, about
30% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 40 (w/w)
to about 90%
(w/w) of one or more oligosaccharides, about 45% (w/w) to about 90% (w/w) of
one or more
oligosaccharides, about 50% (w/w) to about 90% (w/w) of one or more
oligosaccharides, about
55% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 65% (w/w)
to about 90%
(w/w) of one or more oligosaccharides, about 70% (w/w) to about 90% (w/w) of
one or more
oligosaccharides, about 75% (w/w) to about 90% (w/w) of one or more
oligosaccharides, about
80% (w/w) to about 90% (w/w) of one or more oligosaccharides, or about 85%
(w/w) to about
90% (w/w) of one or more oligosaccharides.
[00324] In an embodiment, the soft chew lozenge comprises about 15% (w/w),
about 20% (w/w),
about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w), about 45%
(w/w), about
50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w),
about 80%
(w/w), about 85% (w/w), or about 90% (w/w) of the one or more
oligosaccharides. In an
embodiment, the soft chew lozenge comprises about 70% (w/w), about 75% (w/w)
to about 80%
(w/w), about 85% (w/w), or about 90% (w/w)of the one or more oligosaccharides.
[00325] In an embodiment, the hard molded lozenge is comprised primarily of
the one or more
oligosaccharides.
[00326] Accordingly, in an embodiment, the present application also includes a
soft chew lozenge
comprising:
74
Date Recue/Date Received 2021-08-20

(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 70% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or less; and
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents.
[00327] In an embodiment, the soft chew lozenge comprises about 70% (w/w) to
about 90%
(w/w) of one or more oligosaccharides, about 75% (w/w) to about 90% (w/w) of
one or more
oligosaccharides, about 80% (w/w) to about 90% (w/w) of one or more
oligosaccharides.
[00328] In an embodiment, the soft chew lozenge comprises one or more gelling
agents as
described above. In an embodiment, the buccal dosage form further comprises of
from about 1%
(w/w) to about 20% (w/w), about 1% (w/w) to about 15% (w/w), about 1% (w/w) to
about 10%
(w/w), about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about
8% (w/w) of the
one or more gelling agents. In an embodiment, the soft chew lozenge comprises
of from about
1% (w/w) to about 10% (w/w), about 2% (w/w) to about 10% (w/w), or of from
about 2% (w/w) to
about 8% (w/w) of the one or more gelling agents. In an embodiment, the soft
chew lozenge
comprises of from about 1% (w/w) to about 10% (w/w) of the one or more gelling
agents. In an
embodiment, the soft chew lozenge comprises of from about 2% (w/w) to about
10% (w/w), or of
from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents. In an
embodiment,
the one or more gelling agent is gelatin.
[00329] The present application also includes a soft chew lozenge comprising
about 10% (w/w)
to about 90% (w/w) of one or more oligosaccharides having a degree of
polymerization of about
or less, wherein the one or more oligosaccharides are as described above. In
an embodiment,
the one or more oligosaccharides are selected from fructo-oligosaccharides
(FOS), galacto-
oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof. In an embodiment, the one or more oligosaccharides
are selected
from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and
combinations
thereof. In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides (FOS).
In an embodiment, the fructo-oligosaccharide (FOS) is produced by the partial
enzymatic
hydrolysis from of inulin from natural sources such as from chicory,
artichoke, yacon, dahlia,
onion, garlic, asparagus, banana or agave. In an embodiment, the FOS is
produced by the partial
enzymatic hydrolysis from chicory inulin. In an embodiment, FOS is prepared by
enzymatic
synthesis with sucrose by methods known in the art, for example, by the
transfructosylation of
sucrose by p-fructofuranosidases. In an embodiment, the FOS is raft P95
Oligofructose from
Beneo GmbH New Jersey, U.S.A.
[00330] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or
less, about 4 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
Date Recue/Date Received 2021-08-20

8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or
less. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 8 or
less, about 7 or
less, or about 6, or about 5 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 9 or less. In an embodiment, the one or more
oligosaccharides
have a degree of polymerization of about 8 or less. In an embodiment, the one
or more
oligosaccharides have a degree of polymerization of about 2 to about 10 or
less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9 or less. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 2 to about 8 or less. In an embodiment, the one or
more oligosaccharides
have a degree of polymerization of about 2 to about 10. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8, about
2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10,
about 3 to about 9,
about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about
3 to about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an
embodiment, the one
or more oligosaccharides have a degree of polymerization of about 2 to about
9. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 8. In an embodiment, the one or more oligosaccharides have a degree of
polymerization
of about 3 to about 10. In an embodiment, the one or more oligosaccharides
have a degree of
polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about
5. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 3 to
about 9, or about
3 to about 8. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 3 to about 9. In some embodiments, the one or more
oligosaccharides
have a degree of polymerization of about 3 to about 8.
[00331] In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
10 or less, about
9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or
less. In an embodiment,
the fructo-oligosaccharide has degree of polymerization of about 10 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 9 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 2 to about
10 or less. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
2 to about 8 or
less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about 2 to
76
Date Recue/Date Received 2021-08-20

about 10. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6,
about 2 to about 5, about
3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree
of polymerization
of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to
about 8, or about 3 to
about 5. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In
an embodiment, the
fructo-oligosaccharide has a degree of polymerization of about 2 to about 9.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 2 to about
8. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 10.
In an embodiment, the fructo-oligosaccharide has a degree of polymerization
about 3 to about 9,
about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 9,
about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-
oligosaccharide has a
degree of polymerization of about 3 to about 9, or about 3 to about 8. In an
embodiment, the
fructo-oligosaccharide has a degree of polymerization of about 3 to about 9.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 3 to about
8.
[00332] For the purposes of this application, fructo-oligosaccharide is
considered to include
inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the
oligosaccharide is
fructo-oligosaccharide having a DP of 2). Therefore, when inulobiose is
considered to be an
oligosaccharide, fructo-oligosaccharide having a DP of, for example, 10 or
less which comprises
inulobiose as a natural component is fructo-oligosaccharide having a DP of
about 2 to about 10
or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about
8) wherein the
inulobiose occurring as a natural component of the fructo-oligosaccharide is
an oligosaccharide
having a DP of 2. Further, when inulobiose is considered to be
oligosaccharide, fructo-
oligosaccharide having a DP of, for example, 10 or less which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
(such as about
2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a
heterogenous mixture
of oligosaccharides of different DPs of about 2 to about 10 or less including
inulobiose and
comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) not including
inulobiose.
[00333] It would be appreciated by a person skilled in the art, that when
inulobiose is considered
to be a sugar, then the same fructo-oligosaccharide having a DP of, for
example, 10 or less which
comprises inulobiose as a natural component described above is fructo-
oligosaccharide having
a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to
about 9 or about 3
to about 8) wherein the inulobiose occurring as a natural component of the
fructo-oligosaccharide
is included as a component of the naturally occurring sugars in the fructo-
oligosaccharide.
Accordingly, when inulobiose is considered to be a sugar, then fructo-
oligosaccharide having a
77
Date Recue/Date Received 2021-08-20

DP of, for example, 10 or less comprising inulobiose as a natural component is
fructo-
oligosaccharide having a DP of about 3 to about 10 or less which comprises a
heterogenous
mixture of oligosaccharides of different DPs of about 3 to about 10 or less
not including inulobiose
and comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) including
inulobiose.
[00334] In an embodiment, the fructo-oligosaccharide having a DP of, for
example, 10 or less
comprising inulobiose as a natural component comprises about 0.1 % (w/w) to
about 8% (w/w),
about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 %
(w/w) to about
7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7%
(w/w), about 0.1
% (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 %
(w/w) to about 6%
(w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5%
(w/w), about 1 %
(w/w) to about 5% (w/w), about 0.1 % (w/w) to about 4% (w/w), about 0.5 %
(w/w) to about 4%
(w/w), about 1 % (w/w) to about 4% (w/w), about 0.5 % (w/w) to about 3% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an
embodiment, the fructo-oligosaccharide having a DP of, for example, 10 or less
comprising
inulobiose as a natural component comprises about 0.1 % (w/w) to about 4%
(w/w), about 1 %
(w/w) to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w)
to about 3%
(w/w), of inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide.
[00335] In an embodiment, when inulobiose is defined as a fibre, the fructo-
oligosaccharide
having a DP of, for example, about 10 or less or, for example, a DP of about 2
to about 10 or
less, comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5%
(w/w) of
monosaccharides and/or disaccharides on a dry solid basis of the total weight
of the fructo-
oligosaccharide. In an embodiment, when inulobiose is defined as a sugar, the
fructo-
oligosaccharide having a DP of, for example, about 10 or less or, for example,
a DP of about 3
to about 10 or less, comprises about 1% (w/w) to about 8% (w/w) or 1% (w/w) to
about 10%
(w/w) of monosaccharides and/or disaccharides on a dry solid basis of the
total weight of the
fructo-oligosaccharide. In an embodiment, the soft chew lozenge is free of
added sugars,
sweeteners, and/or sweetening agents as described above.
[00336] In an embodiment, the soft chew lozenge optionally further comprises
one or more
additives selected from emulsifying agents, oils and/or fats, flavourants, and
pH controlling
agents as described above.
[00337] In an embodiment, the soft chew lozenge optionally further comprises
one or more
emulsifying agents. In an embodiment, the soft chew lozenge comprises about 1%
(w/w) or less,
about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, about
5%(w/w) or less,
about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less, about
9% (w/w) or less,
or about 10% (w/w) or less of an emulsifying agent. In an embodiment, the soft
chew lozenge
78
Date Recue/Date Received 2021-08-20

comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or
less, about 4%
(w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
[00338] In an embodiment, the soft chew lozenge optionally further comprises
one or more oils
and/or fats. In an embodiment, the soft chew lozenge further comprises about
10%(w/w) or less,
about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about
6%(w/w) or less,
about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about
2%(w/w) or less,
or about 1%(w/w) or less of the one or more oils and/or fats. In an
embodiment, the soft chew
lozenge further comprises about 5% (w/w) or less, about 4%(w/w) or less, about
3%(w/w) or less,
about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or
fats. In an
embodiment, the soft chew lozenge comprises about 0.1% (w/w) to about 5%
(w/w), about 0.1%
(w/w) to about 3% (w/w) or about 0.1 % (w/w) to about 2% (w/w) or about 0.1 %
(w/w) to about
1 % (w/w) of one or more oils and/or fats as described above.
[00339] In an embodiment, the soft chew lozenge further comprises from about
0.5% (w/w) to
about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w)
to about
8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to
about 6%(w/w),
from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w)
of the one or
more oils and/or fats.
[00340] In an embodiment, the soft chew lozenge optionally further comprises
one or more oils
and/or fats. In an embodiment, the soft chew lozenge further = comprises about
1.0%(w/w) or
less of one or more oils and/or fats. In an embodiment, the buccal dosage form
further comprises
about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less,
about OA% (w/w)
or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7%
(w/w) or less of the
one or more oils and/or fats.
[00341] In an embodiment, the soft chew lozenge optionally further comprises
one or more pH
modifying agents. In an embodiment, the soft chew lozenge comprises about 1%
(w/w) or less,
about 2%(w/w) or less, about 3%(w/w) or less, or about 4%(w/w) or less of the
one or more pH
modifying agents. In an embodiment, the soft chew lozenge comprises about 1%
(w/w) or less,
or about 2%(w/w) or less of the one or more pH modifying agents.
[00342] In an embodiment, the soft chew lozenge optionally further comprises
one or more
flavourants. In an embodiment, the soft chew lozenge comprises about 5%(w/w)
or less, about
4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about
1%(w/w) or less of the
one or more flavourants. In an embodiment, the soft chew lozenge comprises
about 2%(w/w) or
less, or about 1%(w/w) or less of the one or more flavourants. In an
embodiment, the soft chew
lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to
about 2% (w/w)
of the one or more flavourants.
[00343] Accordingly, in an embodiment, the present application includes a soft
chew lozenge
comprising:
79
Date Recue/Date Received 2021-08-20

(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 10% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
[00344] In an embodiment, the soft chew lozenge is comprised primarily of the
one or more
oligosaccharides. Accordingly, in an embodiment, the present application
includes a soft chew
lozenge comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid
extract;
(b) about 70% (w/w) to about 90% (w/w) of one or more oligosaccharides having
a degree
of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(f) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
[00345] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) to about
70% (w/w), about 10% (w/w) to about 70% (w/w), about 10% (w/w) to about 65%
(w/w), about
10% (w/w) to about 60% (w/w), about 10% (w/w) to about 55% (w/w), about 10%
(w/w) to about
55% (w/w), about 10% (w/w) to about 50% (w/w), about 10% (w/w) to about 45%
(w/w) water,
about 10% (w/w) to about 40% (w/w) water about 10% (w/w) to about 35% (w/w)
water, about
10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water,
or about 10%
(w/w) to about 20% (w/w) water. In an embodiment, the soft chew lozenge
further comprises
about 10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w)
water, or about
10% (w/w) to about 20% (w/w) water.
[00346] In an embodiment, the soft chew lozenge comprises about 70% (w/w) to
about 90%
(w/w) of one or more oligosaccharides, about 75% (w/w) to about 90% (w/w) of
one or more
oligosaccharides, about 80% (w/w) to about 90% (w/w) of one or more
oligosaccharide.
[00347] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts are as described above. In
an
Date Recue/Date Received 2021-08-20

embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof. In an
embodiment, the one or more cannabinoids is THC.
[00348] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 2 to about 10, about 2 to about 9,
about 2 to about 8 or
about 3 to about 8. In an embodiment, the one or more oligosaccharides are
selected from fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and
raffinose family
of oligosaccharides, and combinations thereof. In an embodiment, the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
[00349] In an embodiment, the soft chew lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00350] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more emulsifying agents. In an embodiment, the soft chew lozenge
further comprises
about 1.0%(w/w) or less of the one or more emulsifying agents. In an
embodiment, the soft chew
lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3%
(w/w) or less, or
about 4% (w/w) or less of the one or more emulsifying agents. In an
embodiment, the one or
more emulsifying agents are selected from gum Arabic, modified gum Arabic,
lecithins,
hydroxylated lecithin, and hydrolyzed lecithin. In an embodiment, the lecithin
is soy lecithin or
sunflower lecithin. In an embodiment, the lecithin is soy lecithin.
[00351] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more oils and/or fats. In an embodiment, the soft chew lozenge
comprises about 1.0%(
w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew
lozenge further
comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less,
or about
1%(w/w) or less of the one or more oils and/or fats. In an embodiment, the one
or more oils are
vegetable oils. In an embodiment, the hard molded lozenge does not comprise a
fat.
[00352] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more emulsifying agents and further comprises about 5% (w/w) or less of
one or more oils
and/or fats. In an embodiment, the soft chew lozenge comprises about 1% (w/w)
or less, about
2%(w/w) or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one
or more emulsifying
agents. In an embodiment, the soft chew lozenge further comprises about
4%(w/w) or less, about
3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or
more oils and/or
fats.
[00353] In an embodiment, the soft chew lozenge optionally further comprises
one or more
additives selected from flavourants, and pH controlling agents as described
above.
81
Date Recue/Date Received 2021-08-20

[00354] In an embodiment, the soft chew lozenge comprises about 1% (w/w) or
less, or about
2%(w/w) or less of the one or more pH modifying agents. In an embodiment, the
one or more pH
modifying agents are selected from citric acid, malic acid, tartaric acid and
ascorbic acid and
combinations therefore, and salts thereof. In an embodiment, the pH modifying
agent is citric
acid.
[00355] In an embodiment, the soft chew lozenge comprises about 2%(w/w) or
less, or about
1%(w/w) or less of the one or more flavourants. In an embodiment, the hard
molded lozenge
comprises about 1%(w/w) or less of the one or more flavourants. In an
embodiment, the soft
chew lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w)
to about 2%
(w/w) of the one or more flavourants. In an embodiment, the one or more
flavourants are selected
from eucalyptus, peppermint oils and menthol.
[00356] In an embodiment, the soft chew lozenge optionally further comprises
one or more
polysaccharides. In an embodiment, the one or more polysaccharides have a
degree of
polymerization of up to about 80 and have an average degree of polymerization
of about 9 or
greater. In an embodiment, when present the added % (w/w) of the one or more
polysaccharides
replaces an equal % (w/w) of the one or more oligosaccharides in soft chew
lozenge.
[00357] Accordingly, the present application includes a soft chew lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 89.9% (w/w) of one or more oligosaccharides
having a of
polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents; and
(d) about 0.1% (w/w) to about 80% (w/w) of one or more polysaccharides having
a
degree of polymerization of up to about 80 and having an average degree of
polymerization of about 9 or greater.
[00358] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
[00359] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00360] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract, the one
or more oligosaccharides and the one or more polysaccharides are present in a
weight ratio of
about 1:900 to about 1:5, about 1:800 to about 1:5, about 1:700 to about 1:5,
about 1:600 to
about 1:5, about 1:500 to about 1:5, about 1:400 to about 1:5, about 1:300 to
about 1:5, about
82
Date Recue/Date Received 2021-08-20

1:200 to about 1:5, about 1:150 to about 1:5, about 1:100 to about 1:5, about
1:400 to about 1:50,
about 1:400 to about 1:100, about 1:300 to about 1:100, about 1:300, about
1:200, about 1:150
or about 1:100 of the one or more cannabinoids, and/or a cannabinoid extract
to the one or more
oligosaccharides and the one or more polysaccharides combined.
[00361] In an embodiment, the soft chew lozenge comprises about 0.5% (w/w) to
about 80%
(w/w), about 1 % (w/w) to about 80% (w/w), about 5% (w/w) to about 80% (w/w),
about 10% (w/w)
to about 80%(w/w), about 15% (w/w) to about 80% (w/w), about 20% (w/w) to
about 80% (w/w),
about 25% (w/w) to about 80%(w/w), about 30% (w/w) to about 80% (w/w), about
35% (w/w) to
about 80% (w/w), about 40% (w/w) to about 80%(w/w), about 45% (w/w) to about
80% (w/w),
about 50% (w/w) to about 80% (w/w), about 55% (w/w) to about 80%(w/w), about
60% (w/w) to
about 80% (w/w), about 65% (w/w) to about 80% (w/w), about 70% (w/w) to about
80%(w/w), or
about 75% (w/w) to about 80% (w/w) of one or more polysaccharides. In an
embodiment, the
soft chew lozenge comprises about 0.1% (w/w) to about 88.9% (w/w), about 0.1%
(w/w) to about
80% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 50%
(w/w), about
0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70% (w/w), about 5%
(w/w) to about
50% (w/w), about 10% (w/w) to about 70%(w/w), about 15% (w/w) to about 60%
(w/w), about
20% (w/w) to about 75% (w/w), about 0.1% (w/w) to about 74% (w/w), about 25%
(w/w) to about
75%(w/w), about 40% (w/w) to about 70% (w/w), about 40% (w/w) to about 60%
(w/w), about
10% (w/w) to about 30%(w/w), about 15% (w/w), about 25% (w/w), or about 50%
(w/w), about
75% (w/w) of one or more polysaccharides.
[00362] In an embodiment, when one or more polysaccharides are present, the
soft chew
lozenge comprises about 15% (w/w) to about 89.9% (w/w) of one or more
oligosaccharides,
about 20% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about
25% (w/w) to
about 89.9% (w/w) of one or more oligosaccharides, about 30% (w/w) to about
89.9% (w/w) of
one or more oligosaccharides, about 40 (w/w) to about 89.9% (w/w) of one or
more
oligosaccharides, about 45% (w/w) to about 89.9% (w/w) of one or more
oligosaccharides, about
50% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 55%
(w/w) to about
89.9% (w/w) of one or more oligosaccharides, about 65% (w/w) to about 89.9%
(w/w) of one or
more oligosaccharides, about 70% (w/w) to about 89.9% (w/w) of one or more
oligosaccharides,
about 75% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about
80% (w/w) to
about 89.9% (w/w) of one or more oligosaccharides, about 85% (w/w) to about
89.9% (w/w) of
one or more oligosaccharides, about 45% (w/w) to about 80% (w/w) of one or
more
oligosaccharides, about 50% (w/w) to about 80% (w/w) of one or more
oligosaccharides, or about
55% (w/w) to about 80% (w/w) of one or more oligosaccharides.
[00363] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 90% (w/w), about
60% (w/w) to
about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w) to about
90% (w/w),
about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or
about 85% (w/w)
83
Date Recue/Date Received 2021-08-20

to about 90% (w/w) of the total weight of the soft chew lozenge. In an
embodiment, the one or
more oligosaccharides and the one or more polysaccharides combined comprise
about 60%
(w/w) to about 80% (w/w) or about 60% (w/w) to about 70% (w/w) of the total
weight of the soft
chew lozenge.
[00364] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 90% (w/w) of the
soft chew
lozenge.
[00365] Accordingly, the present application includes a soft chew lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 89.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents; and
(d) about 0.1% (w/w) to about 80% (w/w) of one or more polysaccharides having
a
degree of polymerization of up to about 80 and having an average degree of
polymerization of about 9 or greater, wherein the one or more oligosaccharides
and the
one or more polysaccharides combined comprise about 55% (w/w) to about 90%
(w/w)
of the soft chew lozenge.
[00366] In an embodiment, the one or more polysaccharides are as described
above. In an
embodiment, the one or more polysaccharides is inulin. Accordingly, in an
embodiment, the soft
chew lozenge comprises about 0.1% (w/w) to about 80% (w/w) of inulin having a
degree of
polymerization of up to 60 and having an average degree of polymerization of
about 9 or greater.
In another embodiment, the buccal dosage comprises about 0.1% (w/w) to about
80% (w/w) of
inulin having a degree of polymerization of up to 60 and having an average
degree of
polymerization of about 9 or greater, wherein the one or more oligosaccharides
and the inulin
combined comprise about 55% (w/w) to about 80% (w/w) of the soft chew lozenge.
[00367] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a
degree of
polymerization of about 3 to about 60, or about 10 to about 60. In an
embodiment, the inulin has
a degree of polymerization of about 10 to about 60. In an embodiment, the
inulin has an average
degree of polymerization of about 10 or greater.
[00368] In an embodiment, the soft chew lozenge optionally further comprises
one or more
additives selected from emulsifying agents, oils and/or fats, flavourants, and
pH modifying agents
as described above for the hard molded lozenge without one or more
polysaccharides.
[00369] In an embodiment, the present application also includes a soft chew
lozenge comprising:
84
Date Recue/Date Received 2021-08-20

(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 10% (w/w) to about 89.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 1% (w/w) to about 25% (w/w) of one or more gelling agents;
(d) optionally about 0.1% (w/w) to about 80% (w/w) of one or more
polysaccharides
having a degree of polymerization up to about 80 and having an average degree
of
polymerization of about 9 or greater;
(e) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying
agents;
(f) optionally about 0.1% (w/w) to about 5% (w/w) of one or more oils and/or
fats; and
(g) optionally about 0.1% (w/w) to about 2% (w/w) of one or more pH modifying
agents.
[00370] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 90% (w/w) of the
total weight of
the soft chew lozenge.
[00371] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 55% (w/w) to about 90% (w/w), about
60% (w/w) to
about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w) to about
90% (w/w),
about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or
about 85% (w/w)
to about 90% (w/w) of the total weight of the soft chew lozenge. In an
embodiment, the one or
more oligosaccharides and the one or more polysaccharides combined comprise
about 60%
(w/w) to about 80% (w/w) or about 60% (w/w) to about 70% (w/w) of the total
weight of the soft
chew lozenge.
[00372] In an embodiment, the one or more polysaccharides are as described
above. In an
embodiment, the one or more polysaccharides is inulin as described above.
[00373] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts are as described above. In
an
embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof. In an
embodiment, the one or more cannabinoids is THC.
[00374] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 2 to about 10, about 2 to about 9,
about 2 to about 8 or
about 3 to about 8. In an embodiment, the one or more oligosaccharides are
selected from fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and
raffinose family
Date Recue/Date Received 2021-08-20

of oligosaccharides, and combinations thereof. In an embodiment, the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
[00375] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less or about 6 or less or about
5 or less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 10, about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2
to about 6, about 2
to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about
3 to about 7, about
3 to about 6, or about 3 to about 5. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 2 to about 10, about 2 to about 8 or about 3
to about 8.
[00376] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or
less, about 4 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or
less. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 8 or
less, about 7 or
less, or about 6, or about 5 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 9 or less. In an embodiment, the one or more
oligosaccharides
have a degree of polymerization of about 8 or less. In an embodiment, the one
or more
oligosaccharides have an average degree of polymerization of about 2 to about
10. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2
to about 5, about 3
to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about
3 to about 6, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9,
about 3 to about 8,
or about 3 to about 5. In an embodiment, the one or more oligosaccharides have
a degree of
polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8
or about 3 to about
8. In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
2 to about 9. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 2 to about 8. In an embodiment, the one or more
oligosaccharides have
a degree of polymerization of about 3 to about 10. In an embodiment, the one
or more
oligosaccharides have a degree of polymerization about 3 to about 9, about 3
to about 8, about
3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 3 to about 9, about
3 to about 8, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment,
the one or more
oligosaccharides have a degree of polymerization of about 3 to about 9. In
some embodiment,
the one or more oligosaccharides have a degree of polymerization of about 3 to
about 8.
86
Date Recue/Date Received 2021-08-20

[00377] In an embodiment, the soft chew lozenge is free of added sugars,
sweeteners, and/or
sweetening agents as described above.
[00378] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more emulsifying agents. In an embodiment, the soft chew lozenge
further comprises
about 1.0% (w/w) or less of the one or more emulsifying agents. In an
embodiment, the soft chew
lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3%
(w/w) or less, or
about 4% (w/w) or less of the one or more emulsifying agents. In an
embodiment, the one or
more emulsifying agents are selected from gum Arabic, modified gum Arabic,
lecithins,
hydroxylated lecithin, and hydrolyzed lecithin. In an embodiment, the lecithin
is soy lecithin or
sunflower lecithin. In an embodiment, the lecithin is soy lecithin
[00379] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more oils and/or fats. In an embodiment, the soft chew lozenge
comprises about 1.0%(
w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew
lozenge further
comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less,
or about
1%(w/w) or less of the one or more oils and/or fats. In an embodiment, the one
or more oils are
vegetable oils. In an embodiment, the hard molded lozenge does not comprise a
fat.
[00380] In an embodiment, the soft chew lozenge further comprises about 5%
(w/w) or less of
one or more emulsifying agents and further comprises about 5% (w/w) of one or
more oils and/or
fats. In an embodiment, the soft chew lozenge comprises about 1% (w/w) or
less, about 2%(w/w)
or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one or more
emulsifying agents.
In an embodiment, the soft chew lozenge further comprises about 4%(w/w) or
less, about
3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or
more oils and/or
fats.
[00381] In an embodiment, the soft chew lozenge optionally further comprises
one or more
additives selected from flavourants, and pH controlling agents as described
above.
[00382] In an embodiment, the soft chew lozenge comprises about 1% (w/w) or
less, or about
2%(w/w) or less of the one or more pH modifying agents. In an embodiment, the
one or more pH
modifying agents are selected from citric acid, malic acid, tartaric acid and
ascorbic acid and
combinations therefore, and salts thereof. In an embodiment, the pH modifying
agent is citric
acid.
[00383] In an embodiment, the soft chew lozenge comprises about 2%(w/w) or
less, or about
1%(w/w) or less of the one or more flavourants. In an embodiment, the soft
chew lozenge
comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2%
(w/w) of the
one or more flavourants. In an embodiment, the hard molded lozenge comprises
about 1%(w/w)
or less of the one or more flavourants. In an embodiment, the one or more
flavourants are
selected from eucalyptus, peppermint oils and menthol.
87
Date Recue/Date Received 2021-08-20

Compressed Tablet
[00384] In an embodiment, the Applicant has prepared compressed tablet
lozenges comprising
one or more oligosaccharides.
[00385] Accordingly, the present application also includes a compressed tablet
lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 10% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or less.
[00386] In an embodiment, the compressed tablet further comprises one or more
lubricants. In
an embodiment, the buccal dosage form comprises about 5%(w/w) or less, about
4%(w/w) or
less, about 3% (w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less
of the one or more
lubricants. In an embodiment, the one or more lubricants is as described
above. In an
embodiment, the lubricant is magnesium stearate.
[00387] In an embodiment, the present application includes a compressed tablet
lozenge
comprising one or more cannabinoids, and/or a cannabinoid extract as described
above. In an
embodiment, the present application also includes a compressed table lozenge
comprising one
or more cannabinoids as described above. In an embodiment, the present
application also
includes a compressed tablet lozenge comprising one or more cannabinoid
extracts as described
above. In an embodiment, the one or more cannabinoid extracts is a cannabinoid
distillate. In an
embodiment, the one or more cannabinoids is selected from THC and CBD and
combinations
thereof. In an embodiment, the one or more cannabinoids is THC.
[00388] In an embodiment, the compressed tablet lozenge comprises about 0.1%
(w/w) to about
3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w)
of the one or
more cannabinoids, and/or a cannabinoid extract. In an embodiment, the buccal
dosage form
comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less,
about 0.5% (w/w)
or less, about 03% (w/w) or less, about 0.2% (w/w) or less, or about 0.1%
(w/w) or less of the
one or more cannabinoids, and/or a cannabinoid extract. In an embodiment, the
compressed
tablet lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to
about 2% (w/w), or
about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a
cannabinoid
extract.
[00389] In an embodiment, the compressed tablet lozenge of the application can
be used to
administer any suitable dose of the one or more cannabinoids and/or
cannabinoid extract. In an
embodiment, typical doses of the one or more cannabinoids and/or cannabinoid
extract may be
in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg,
about 0.1mg to
about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg,
about 0.1 mg to
about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about
0.1 mg to
88
Date Recue/Date Received 2021-08-20

about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about
0.1 mg to about
mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to
about 2 mg,
or about 0.1 mg to about 1 mg. In an embodiment, the one or more cannabinoids
and/or
cannabinoid extract is THC and typical doses of THC may be in the range of
about 0.1 mg to
about 10 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid
extract is
THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg,
about 2 mg, about
1mg, about 0.5 mg or about 0.1mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is THC and typical doses of THC may be about 10mg, about
5mg, about 2.5
mg, or about 0.1mg. In an embodiment, the one or more cannabinoids and/or
cannabinoid extract
is CBD and typical doses of CBD may be in the range of about 0.1 mg to about
500 mg, about
0.1mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250
mg, about 0.1
mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg,
about 0.1 mg
to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about
0.1 mg to about
2.5 mg, or about 0.1 mg to about 1 mg. In an embodiment, the one or more
cannabinoids and/or
cannabinoid extract is CBD and typical doses of CBD may be in the range of
about 10mg, about
5 mg, about 2.5 mg, about 1 mg or about 0.1 mg. In an embodiment the
compressed tablet
lozenge comprises more than one cannabinoid and/or cannabinoid extract and the
buccal
dosage form comprises a combination of the suitable doses of each of the
cannabinoid and/or
cannabinoid extract. In an embodiment the compressed tablet lozenge comprises
THC and CBD,
and the buccal dosage form comprises a combination of the suitable doses of
THC and CDB. In
an embodiment, the compressed tablet lozenge comprises 10mg of THC and 2mg of
CBD. In an
embodiment, the compressed tablet lozenge comprises equal amounts of THC and
CBD. In an
embodiment, the compressed tablet lozenge comprises 5mg of THC and 5mg of CBD.
In an
embodiment, the compressed tablet lozenge comprises 2.5mg of THC and 2.5mg of
CBD.
[00390] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract and the
one or more oligosaccharides are present in a weight ratio of about 1:1000 to
about 1:5, about
1:1000 to about 1:100, about 1:1000 to about 1:200, about 1:1000 to about
1:300, about 1:1000
to about 1:400, about 1:1000 to about 1:500, about 1:1000 to about 1:600, or
about 1:1000 to
about 1:700 of the one or more cannabinoids, and/or a cannabinoid extract to
the one or more
oligosaccharides.
[00391] In an embodiment, the buccal dosage form comprises, about 85% (w/w) to
about 98%
(w/w) of one or more oligosaccharides, about 90% (w/w) to about 98% (w/w) of
one or more
oligosaccharides, about 95% (w/w) to about 98% (w/w) of one or more
oligosaccharides, about
96% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 97% (w/w)
to about 98%
(w/w), about 98% (w/w) to about 98% (w/w), about 99% (w/w) to about 98% (w/w),
about 99.5%
89
Date Recue/Date Received 2021-08-20

(w/w) to about 98% (w/w), about 98% (w/w) to about 98% (w/w) or about 99.8%
(w/w) to about
98% (w/w) of one or more oligosaccharides.
[00392] In an embodiment, the buccal dosage form comprises about 15% (w/w),
about 20%
(w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w),
about 45% (w/w),
about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75%
(w/w), about
80% (w/w), about 85% (w/w), about 90% (w/w), about 95% (w/w), about 96% (w/w),
about 97%
(w/w), about 98% (w/w), about 99% (w/w) or about 99% (w/w) or more of the one
or more
oligosaccharides. In an embodiment, the buccal dosage form comprises about 50%
(w/w), about
55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w) to about 80%
(w/w), about 85%
(w/w), about 90% (w/w), about 95% (w/w), about 96% (w/w), about 97% (w/w), or
about 98% of
the one or more oligosaccharides.
[00393] In an embodiment, the compressed tablet lozenge is comprised primarily
of the one or
more oligosaccharides.
[00394] Accordingly, the present application also includes a compressed tablet
lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract; and
(b) about 80% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or more.
[00395] In an embodiment, the compressed tablet lozenge comprises about 85%
(w/w) to about
98% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 95% (w/w)
of one or more
oligosaccharides, or about 92% (w/w) to about 95% (w/w) of one or more
oligosaccharides.
[00396] In an embodiment, the hard molded lozenge comprises the one or more
oligosaccharides
having a degree of polymerization of about 10 or less as described above. In
an embodiment,
the one or more oligosaccharides are selected from fructo-oligosaccharides
(FOS), galacto-
oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-
oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of
oligosaccharides,
and combinations thereof. In an embodiment, the one or more oligosaccharides
are selected
from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and
combinations
thereof. In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides (FOS).
In an embodiment, the fructo-oligosaccharide (FOS) is produced by the partial
enzymatic
hydrolysis from of inulin from natural sources such as from chicory,
artichoke, yacon, dahlia,
onion, garlic, asparagus, banana or agave. In an embodiment, the FOS is
produced by the partial
enzymatic hydrolysis from chicory inulin. In an embodiment, FOS is prepared by
enzymatic
synthesis with sucrose by methods known in the art, for example, by the
transfructosylation of
sucrose by p-fructofuranosidases. In an embodiment, the FOS is raft P95
Oligofructose from
Beneo GmbH New Jersey, U.S.A.
Date Recue/Date Received 2021-08-20

[00397] In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or
less, about 4 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or
less. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 8 or
less, about 7 or
less, or about 6, or about 5 or less. In an embodiment, the one or more
oligosaccharides have a
degree of polymerization of about 9 or less. In an embodiment, the one or more
oligosaccharides
have a degree of polymerization of about 8 or less. In an embodiment, the one
or more
oligosaccharides have a degree of polymerization of about 2 to about 10 or
less. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9 or less. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 2 to about 8 or less. In an embodiment, the one or
more oligosaccharides
have a degree of polymerization of about 2 to about 10. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8, about
2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10,
about 3 to about 9,
about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about
3 to about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an
embodiment, the one
or more oligosaccharides have a degree of polymerization of about 2 to about
9. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 8. In an embodiment, the one or more oligosaccharides have a degree of
polymerization
of about 3 to about 10. In an embodiment, the one or more oligosaccharides
have a degree of
polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about
5. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 3 to
about 9, or about
3 to about 8. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 3 to about 9. In some embodiments, the one or more
oligosaccharides
have a degree of polymerization of about 3 to about 8.
[00398] In an embodiment, the one or more oligosaccharides is fructo-
oligosaccharides. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
10 or less, about
9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or
less. In an embodiment,
the fructo-oligosaccharide has degree of polymerization of about 10 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 9 or less.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
In an embodiment,
91
Date Recue/Date Received 2021-08-20

the fructo-oligosaccharide has a degree of polymerization of about 2 to about
10 or less. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
2 to about 8 or
less. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about 2 to
about 10. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6,
about 2 to about 5, about
3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree
of polymerization
of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to
about 8, or about 3 to
about 5. In an embodiment, the fructo-oligosaccharide has a degree of
polymerization of about
2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In
an embodiment, the
fructo-oligosaccharide has a degree of polymerization of about 2 to about 9.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 2 to about
8. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 10.
In an embodiment, the fructo-oligosaccharide has a degree of polymerization
about 3 to about 9,
about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the fructo-oligosaccharide has a degree of polymerization of about
3 to about 9,
about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-
oligosaccharide has a
degree of polymerization of about 3 to about 9, or about 3 to about 8. In an
embodiment, the
fructo-oligosaccharide has a degree of polymerization of about 3 to about 9.
In an embodiment,
the fructo-oligosaccharide has a degree of polymerization of about 3 to about
8.
[00399] For the purposes of this application, fructo-oligosaccharide is
considered to include
inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the
oligosaccharide is
fructo-oligosaccharide having a DP of 2). Therefore, when inulobiose is
considered to be an
oligosaccharide, fructo-oligosaccharide having a DP of, for example, 10 or
less which comprises
inulobiose as a natural component is fructo-oligosaccharide having a DP of
about 2 to about 10
or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about
8) wherein the
inulobiose occurring as a natural component of the fructo-oligosaccharide is
an oligosaccharide
having a DP of 2. Further, when inulobiose is considered to be
oligosaccharide, fructo-
oligosaccharide having a DP of, for example, 10 or less which comprises
inulobiose as a natural
component is fructo-oligosaccharide having a DP of about 2 to about 10 or less
(such as about
2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a
heterogenous mixture
of oligosaccharides of different DPs of about 2 to about 10 or less including
inulobiose and
comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) not including
inulobiose.
[00400] It would be appreciated by a person skilled in the art, that when
inulobiose is considered
to be a sugar, then the same fructo-oligosaccharide having a DP of, for
example, 10 or less which
comprises inulobiose as a natural component described above is fructo-
oligosaccharide having
a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to
about 9 or about 3
92
Date Recue/Date Received 2021-08-20

to about 8) wherein the inulobiose occurring as a natural component of the
fructo-oligosaccharide
is included as a component of the naturally occurring sugars in the fructo-
oligosaccharide.
Accordingly, when inulobiose is considered to be a sugar, then fructo-
oligosaccharide having a
DP of, for example, 10 or less comprising inulobiose as a natural component is
fructo-
oligosaccharide having a DP of about 3 to about 10 or less which comprises a
heterogenous
mixture of oligosaccharides of different DPs of about 3 to about 10 or less
not including inulobiose
and comprises naturally occurring sugars (Le., monosaccharides and/or
disaccharides) including
inulobiose.
[00401] In an embodiment, the fructo-oligosaccharide having a DP of, for
example, 10 or less
comprising inulobiose as a natural component comprises about 0.1 % (w/w) to
about 8% (w/w),
about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 %
(w/w) to about
7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7%
(w/w), about 0.1
% (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 %
(w/w) to about 6%
(w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5%
(w/w), about 1 %
(w/w) to about 5% (w/w), about 0.1 % (w/w) to about 4% (w/w), about 0.5 %
(w/w) to about 4%
(w/w), about 1 % (w/w) to about 4% (w/w), about 0.5 % (w/w) to about 3% (w/w),
about 1 % (w/w)
to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3% (w/w), of
inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide. In an
embodiment, the fructo-oligosaccharide having a DP of, for example, 10 or less
comprising
inulobiose as a natural component comprises about 0.1 % (w/w) to about 4%
(w/w), about 1 %
(w/w) to about 3% (w/w), about 15% (w/w) to about 3% (w/w), about 2 % (w/w) to
about 3%
(w/w), of inulobiose on a dry solid basis of the total weight of the fructo-
oligosaccharide.
[00402] In an embodiment, when inulobiose is defined as a fibre, the fructo-
oligosaccharide
having a DP of, for example, about 10 or less or, for example, a DP of about 2
to about 10 or
less, comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5%
(w/w) of
monosaccharides and/or disaccharides on a dry solid basis of the total weight
of the fructo-
oligosaccharide. In an embodiment, when inulobiose is defined as a sugar, the
fructo-
oligosaccharide having a DP of, for example, about 10 or less or, for example,
a DP of about 3
to about 10 or less, comprises about 1% (w/w) to about 8% (w/w) or 1% (w/w) to
about 10%
(w/w) of monosaccharides and/or disaccharides on a dry solid basis of the
total weight of the
fructo-oligosaccharide. In an embodiment, the compressed tablet lozenge is
free of added
sugars, sweeteners, and/or sweetening agents as described above.
[00403] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more additives selected from emulsifying agents, oils and/or fats,
flavourants, and pH controlling
agents as described above.
[00404] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more emulsifying agents. In an embodiment, the buccal dosage form comprises
about 1% (w/w)
93
Date Recue/Date Received 2021-08-20

or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or
less, about 5%(w/w)
or less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or
less, about 9% (w/w)
or less, or about 10% (w/w) or less of an emulsifying agent. In an embodiment,
the buccal dosage
form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w)
or less, about
4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying
agents. In an
embodiment, the compressed tablet lozenge comprises about 1% (w/w) or less,
about 2%(w/w)
or less of the one or more emulsifying agents.
[00405] In an embodiment, the compressed tablet lozenge further comprises less
than about
0.5% (w/w) to less than about 10% (w/w), from less than about 0.5% (w/w) to
less than about
9%(w/w), from less than about 0.5% (w/w) to less than about 8%(w/w), from less
than about 0.5%
(w/w) to less than about 7%(w/w), from less than about 0.5% (w/w) to less than
about 6%(w/w),
from less than about 0.5% (w/w) to less than about 5%(w/w), from less than
about 0.5% (w/w) to
less than about 4%(w/w) of the one or more emulsifying agents.
[00406] In an embodiment, the compressed tablet lozenge optionally comprises
about 1.0%(
w/w) or less of the one or more emulsifying agents. In an embodiment, the
buccal dosage form
optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about
03% (w/w) or
less, about OA% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or
less, or about 07%
(w/w) or less of the one or more emulsifying agents.
[00407] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more oils and/or fats. In an embodiment, the compressed tablet lozenge
comprises about
10%(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w)
or less, about
6%(w/w) or less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w)
or less, about
2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
In an embodiment,
the compressed tablet lozenge further comprises about 3%(w/w) or less, about
2%(w/w) or less,
or about 1%(w/w) or less of the one or more oils and/or fats.
[00408] In an embodiment, the compressed tablet lozenge further comprises from
about 0.5%
(w/w) to about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about
0.5% (w/w) to
about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w)
to about
6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to
about 4%(w/w) of
the one or more oils and/or fats.
[00409] In an embodiment, the compressed tablet lozenge optionally further
comprises about
1.0%(w/w) or less of one or more oils and/or fats. In an embodiment, the
buccal dosage form
further comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about
0.3% (w/w) or less,
about OA% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less,
or about 07%
(w/w) or less of the one or more oils and/or fats.
[00410] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more flavourants. In an embodiment, the compressed tablet lozenge comprises
about 1.0%(w/w)
94
Date Recue/Date Received 2021-08-20

or less of the one or more flavourants. In an embodiment, the compressed
tablet lozenge
comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2%
(w/w) of the
one or more flavourants. In an embodiment, the compressed tablet lozenge
comprises about
0.1% (w/w), about 0.2%(w/w), about 0.3% (w/w), about OA% (w/w), about 0.5%
(w/w), about
0.6% (w/w), or about 0.7% (w/w) of the one or more flavourants.
[00411] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more pH modifying agents. In an embodiment, the compressed tablet lozenge
comprises about
1.0%(w/w) or less of the pH modifying agent. In an embodiment, the compressed
tablet lozenge
further comprises about 0.1% (w/w), about 0.2%(w/w), or about 0.3% (w/w) of
the pH modifying
agent.
[00412] Accordingly, in an embodiment, the present application also includes a
compressed
tablet lozenge comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 10% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(d) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents;
and
(e) optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or
fats.
[00413] In an embodiment, the compressed tablet lozenge is comprised primarily
of the one or
more oligosaccharides Accordingly, in an embodiment, the present application
also includes a
compressed tablet lozenge comprising:
(a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a
cannabinoid extract;
(b) about 80% (w/w) to about 98% (w/w) of one or more oligosaccharides having
a
degree of polymerization of about 10 or less;
(c) optionally about 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(d) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents;
and
(e) optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or
fats.
[00414] In an embodiment, the compressed tablet lozenge comprises about 85%
(w/w) to about
98% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 95% (w/w)
of one or more
oligosaccharides, or about 92% (w/w) to about 95% (w/w) of one or more
oligosaccharides.
Date Recue/Date Received 2021-08-20

[00415] In an embodiment, the compressed tablet lozenge comprises about
5%(w/w) or less,
about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about
1%(w/w) or less
of the one or more lubricants. In an embodiment, the one or more lubricants is
as described
above. In an embodiment, the one or more lubricants is magnesium stearate.
[00416] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts are as described above. In
an
embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof. In an
embodiment, the one or more cannabinoids is THC.
[00417] In an embodiment, the one or more oligosaccharides are selected from
fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and
raffinose family
of oligosaccharides, and combinations thereof. In an embodiment, the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
[00418] In an embodiment, the compressed tablet lozenge is free of added
sugars, sweeteners,
and/or sweetening agents as described above.
[00419] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more emulsifying agents. In an embodiment, the compressed
tablet lozenge further
comprises about 1.0%(w/w) or less of the one or more emulsifying agents. In an
embodiment,
the one or more emulsifying agents are as described above. In an embodiment,
the one or more
emulsifying agents are selected from gum Arabic, modified gum Arabic,
lecithins, hydroxylated
lecithin, and hydrolyzed lecithin. In an embodiment, the lecithin is soy
lecithin or sunflower
lecithin. In an embodiment, the lecithin is soy lecithin.
[00420] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more oils and/or fats. In an embodiment, the compressed tablet
lozenge comprises
about 1.0%(w/w) or less of the one or more of the oils and/or fats. In an
embodiment, the one or
more oils and/or fats are as described above. In an embodiment, the one or
more oils are
vegetable oils. In an embodiment, the compressed tablet lozenge does not
comprise a fat.
[00421] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more emulsifying agents and further comprises about 2% (w/w) or
less of one or
more oils and/or fats. In an embodiment, the compressed tablet lozenge further
comprises about
1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the
compressed
tablet lozenge comprises about 1.0%(w/w) or less of the one or more oils
and/or fats.
96
Date Recue/Date Received 2021-08-20

[00422] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more additives selected from flavourants, and pH controlling agents as
described above.
[00423] In an embodiment, the compressed tablet lozenge comprises about 1%
(w/w) or less of
the one or more pH modifying agents. In an embodiment, the one or more pH
modifying agents
are as described above. In an embodiment, the one or more pH modifying agents
are selected
from citric acid, malic acid, tartaric acid and ascorbic acid and combinations
therefore, and salts
thereof. In an embodiment, the pH modifying agent is citric acid.
[00424] In an embodiment, the compressed tablet lozenge comprises about
1%(w/w) or less of
the one or more flavourants. In an embodiment, the compressed tablet lozenge
comprises about
0.1% (w/w) to about 2% (w/w) of the one or more flavourants. In an embodiment,
the one or more
flavourants are as described above. In an embodiment, the one or more
flavourants are selected
from eucalyptus, peppermint oils and menthol.
[00425] In an embodiment, the compressed tablet lozenge may also comprise
further excipients
used in the formation of compressed tablet lozenge such as carriers (e.g.,
lactose or corn starch)
and binding agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or
hydroxypropyl
methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or
calcium phosphate);
disintegrants (e.g., potato starch, sodium starch glycolate croscarmellose
sodium, and
crospovidone); or wetting agents (e.g., sodium lauryl sulphate).
[00426] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more polysaccharides. In an embodiment, the one or more polysaccharides have a
degree of
polymerization of up to about 80 and have an average degree of polymerization
of about 9 or
greater. In an embodiment, when present the added % (w/w) of the one or more
polysaccharides
replaces an equal % (w/w) of the one or more oligosaccharides in the buccal
dosage form.
[00427] Accordingly, the present application includes a compressed tablet
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a degree
of polymerization of about 10 or less; and
(c) about 0.1% (w/w) to about 88% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to about 80 and having an average degree of
polymerization of about 9
or greater.
[00428] In an embodiment, the one or more polysaccharides have a degree of
polymerization of
about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to
about 60, about 5 to
about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40,
about 10 to about
30, or about 10 to about 20. In an embodiment, the one or more polysaccharides
have a degree
of polymerization of about 10 to about 60.
97
Date Recue/Date Received 2021-08-20

[00429] In an embodiment, the one or more polysaccharides have an average
degree of
polymerization of about 10 or greater.
[00430] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract, the one
or more oligosaccharides and the one or more polysaccharides are present in a
weight ratio of
about 1:1000 to about 1:5, about 1:1000 to about 1:100, about 1:1000 to about
1:200, about
1:1000 to about 1:300, about 1:1000 to about 1:400, about 1:1000 to about
1:500, about 1:1000
to about 1:600, or about 1:1000 to about 1:700 of the one or more
cannabinoids, and/or a
cannabinoid extract to one or more oligosaccharides and the one or more
polysaccharides
combined.
[00431] In an embodiment, when the one or more polysaccharides are present,
the compressed
tablet lozenge comprises about 70% (w/w) to about 97.9% (w/w) of one or more
oligosaccharides, about 75% (w/w) to about 97.9% (w/w) of one or more
oligosaccharides, about
85% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 90%
(w/w) to about
97.9% (w/w) of one or more oligosaccharides, about 95% (w/w) to about 97.9%
(w/w) of one or
more oligosaccharides, about 96% (w/w) to about 97.9% (w/w) of one or more
oligosaccharides,
about 97% (w/w) to about 97.9% (w/w) of one or more oligosaccharides.
[00432] In an embodiment, the buccal dosage form comprises about 0.5% (w/w) to
about 88%
(w/w), about 1 % (w/w) to about 88% (w/w), about 5% (w/w) to about 88% (w/w),
about 10% (w/w)
to about 88%(w/w), about 15% (w/w) to about 88% (w/w), about 20% (w/w) to
about 88% (w/w),
about 25% (w/w) to about 88%(w/w), about 30% (w/w) to about 88% (w/w), about
35% (w/w) to
about 88% (w/w), about 40% (w/w) to about 88%(w/w), about 45% (w/w), about 88%
(w/w), about
50% (w/w) to about 88% (w/w), about 55% (w/w) to about 88%(w/w), about 60%
(w/w), about
88% (w/w), about 65% (w/w) to about 88% (w/w), about 70% (w/w) to about
88%(w/w), about
75% (w/w) to about 88% (w/w), about 80% (w/w), about 88% (w/w), or about 85%
(w/w), about
88% (w/w) of one or more polysaccharides.
[00433] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 90% (w/w) to about 98% (w/w) of the
compressed
tablet lozenge.
[00434] Accordingly, the present application includes a compressed tablet
lozenge comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less; and
(c) about 0.1% (w/w) to about 88% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to about 80 and having an average degree of
polymerization of
about 9 or greater, wherein the one or more oligosaccharides and the one or
more
98
Date Recue/Date Received 2021-08-20

polysaccharides combined comprise about 90% (w/w) to about 98% (w/w) of the
compressed tablet lozenge.
[00435] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 90% (w/w) to about 97% (w/w), about
90% (w/w) to
about 96% (w/w), or about 90% (w/w) to about 95% of the compressed tablet
lozenge.
[00436] In an embodiment, the one or more polysaccharides are as described
above. In an
embodiment, the one or more polysaccharides is inulin. Accordingly, in an
embodiment, the
compressed tablet lozenge comprises about 0.1% (w/w) to about 88% (w/w) of
inulin having a
degree of polymerization of up to 60 and having an average degree of
polymerization of about 9
or greater. In another embodiment, the buccal dosage comprises about 0.1%
(w/w) to about 88%
(w/w) of inulin having a degree of polymerization of up to 60 and having an
average degree of
polymerization of about 9 or greater, wherein the one or more oligosaccharides
and the inulin
combined comprise about 90% (w/w) to about 98% of the compressed tablet
lozenge.
[00437] In an embodiment, the inulin has a degree of polymerization of about 2
to about 60, about
3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a
degree of
polymerization of about 3 to about 60, or about 10 to about 60. In an
embodiment, the inulin has
a degree of polymerization of about 10 to about 60. In an embodiment, the
inulin has an average
degree of polymerization of about 10 or greater.
[00438] In an embodiment, the compressed tablet lozenge is free of added
sugars, sweeteners,
and/or sweetening agents as described above.
[00439] In an embodiment, the hard molded lozenge optionally further comprises
one or more
additives selected from emulsifying agents, oils and/or fats, flavourants,
gelling agents and pH
modifying agents as described above for the compressed tablet lozenge without
the one or more
polysaccharides.
[00440] In an embodiment, the present application also includes a compressed
tablet lozenge
comprising:
(a) one or more cannabinoids, and/or a cannabinoid extract;
(b) about 10% (w/w) to about 97.9% (w/w) of one or more oligosaccharides
having a
degree of polymerization of about 10 or less;
(c) about 0.1% (w/w) to about 88% (w/w) of one or more polysaccharides having
a degree
of polymerization of up to about 80 and having an average degree of
polymerization of
about 9 or greater;
(d) optionally about 0.1% (w/w) to about 5%(w/w) of one or more lubricants;
(e) optionally about 0.1% (w/w) to about 2% (w/w) of one or more emulsifying
agents;
and
99
Date Recue/Date Received 2021-08-20

(f) optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or
fats.
[00441] In an embodiment, the one or more oligosaccharides and the one or more
polysaccharides combined comprise about 90% (w/w) to about 97% (w/w), about
90% (w/w) to
about 96% (w/w), or about 90% (w/w) to about 95% of the compressed tablet
lozenge.
[00442] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are as
described above. In an embodiment, the one or more cannabinoids are as
described above. In
an embodiment, the one or more cannabinoid extracts are as described above. In
an
embodiment, the one or more cannabinoid extracts is a cannabinoid distillate.
In an embodiment,
the one or more cannabinoids is selected from THC and CBD and combinations
thereof. In an
embodiment, the one or more cannabinoids is THC.
[00443] In an embodiment, the one or more oligosaccharides are selected from
fructo-
oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-
oligosaccharides, manno-
oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and
raffinose family
of oligosaccharides, and combinations thereof. In an embodiment, the one or
more
oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-
oligosaccharides
(GOS) and combinations thereof. In an embodiment, the one or more
oligosaccharides is fructo-
oligosaccharides (FOS).
[00444] In an embodiment, the one or more oligosaccharides have an average
degree of
polymerization of about 9 or less, about 8 or less, about 7 or less, about 6
or less, about 5 or
less, about 4 or less. In an embodiment, the one or more oligosaccharides have
a degree of
polymerization of about 8 or less, about 7 or less, or about 6 or less, about
5 or less, about 4 or
less. In an embodiment, the one or more oligosaccharides have a degree of
polymerization of
about 8 or less, about 7 or less, or about 6, or about 5 or less. In an
embodiment, the one or
more oligosaccharides have a degree of polymerization of about 9 or less,
about 8 or less, about
7 or less or about 6 or less or about 5 or less. In an embodiment, the one or
more
oligosaccharides have a degree of polymerization of about 9 or less. In an
embodiment, the one
or more oligosaccharides have a degree of polymerization of about 8 or less.
In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 2 to
about 10 or less.
In an embodiment, the one or more oligosaccharides have a degree of
polymerization of about
2 to about 9 or less. In an embodiment, the one or more oligosaccharides have
a degree of
polymerization of about 2 to about 8 or less. In an embodiment, the one or
more oligosaccharides
have a degree of polymerization of about 2 to about 10. In an embodiment, the
one or more
oligosaccharides have a degree of polymerization of about 2 to about 9, about
2 to about 8, about
2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10,
about 3 to about 9,
about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to
about 5. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about
3 to about 5. In an
100
Date Recue/Date Received 2021-08-20

embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an
embodiment, the one
or more oligosaccharides have a degree of polymerization of about 2 to about
9. In an
embodiment, the one or more oligosaccharides have a degree of polymerization
of about 2 to
about 8. In an embodiment, the one or more oligosaccharides have a degree of
polymerization
of about 3 to about 10. In an embodiment, the one or more oligosaccharides
have a degree of
polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7,
about 3 to about 6, or
about 3 to about 5. In an embodiment, the one or more oligosaccharides have a
degree of
polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about
5. In an embodiment,
the one or more oligosaccharides have a degree of polymerization of about 3 to
about 9, or about
3 to about 8. In an embodiment, the one or more oligosaccharides have a degree
of
polymerization of about 3 to about 9. In some embodiments, the one or more
oligosaccharides
have a degree of polymerization of about 3 to about 8.
[00445] In an embodiment, the compressed tablet lozenge is free of added
sugars, sweeteners,
and/or sweetening agents as described above.
[00446] In an embodiment, the compressed tablet lozenge comprises about
4%(w/w) or less,
about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the
one or more
lubricants. In an embodiment, the one or more lubricants is as described
above. In an
embodiment, the one or more lubricants is magnesium stearate.
[00447] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more emulsifying agents. In an embodiment, the compressed
tablet lozenge further
comprises about 1.0%(w/w) or less of the one or more emulsifying agents.
[00448] In an embodiment, the one or more emulsifying agents are as described
above. In an
embodiment, the one or more emulsifying agents are selected from gum Arabic,
modified gum
Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an
embodiment, the lecithin is
soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy
lecithin.
[00449] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more oils and/or fats. In an embodiment, the compressed tablet
lozenge comprises
about 1.0%(w/w) or less of the one or more oils and/or fats. In an embodiment,
the one or more
oils and/or fats are as described above. In an embodiment, the one or more
oils are vegetable
oils. In an embodiment, the compressed tablet lozenge does not comprise a fat.
[00450] In an embodiment, the compressed tablet lozenge further comprises
about 2% (w/w) or
less of one or more emulsifying agents and further comprises about 2% (w/w) or
less of one or
more oils and/or fats. In an embodiment, the compressed tablet lozenge further
comprises about
1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the
compressed
tablet lozenge comprises about 1.0%(w/w) or less of the one or more
emulsifying agents and
further comprises about 1% (w/w) or less of one or more oils and/or fats.
101
Date Recue/Date Received 2021-08-20

[00451] In an embodiment, the compressed tablet lozenge optionally further
comprises one or
more additives selected from flavourants, and pH controlling agents as
described above.
[00452] In an embodiment, the compressed tablet lozenge comprises about 1%
(w/w) or less of
the one or more pH modifying agents. In an embodiment, the one or more pH
modifying agents
are as described above. In an embodiment, the one or more pH modifying agents
are selected
from citric acid, malic acid, tartaric acid and ascorbic acid and combinations
therefore, and salts
thereof. In an embodiment, the pH modifying agent is citric acid.
[00453] In an embodiment, the compressed tablet lozenge comprises about
1%(w/w) or less of
the one or more flavourants. In an embodiment, the compressed tablet lozenge
comprises about
0.1% (w/w) to about 1% (w/w) of the one or more flavourants. In an embodiment,
the one or more
flavourants are as described above. In an embodiment, the one or more
flavourants are selected
from eucalyptus, peppermint oils and menthol.
[00454] The Applicant has found that the buccal dosage forms of the
application comprising one
or more oligosaccharides such as fructo-oligosaccharide provide a satisfying
tactile or "mouth
feel" and/or a pleasant flavor experience. Therefore, the buccal dosage forms
of the application
promote retention time of the dosage form in the oral cavity of a subject. In
an embodiment,
retention of the dosage form in the oral cavity of a subject increases
bioavailability and bypasses
first pass metabolism.
[00455] The Applicant has found that otherwise identical buccal dosage forms
except wherein
the one or more oligosaccharides are replaced by polysaccharides such as
inulin as defined
herein were difficult to manufacture due to lower rate of dissolution, high
resulting viscosity in
solution, high temperature of solidification and rapid rate of solidification.
Surprisingly, the one
or more oligosaccharides could be used without difficulty in preparing the
buccal dosage forms
of the application and without added sugars, sweeteners, and/or sweetening
agents to aid in the
manufacturing process. Therefore, the Applicants unexpectedly found that the
buccal dosage
forms of the application comprising one or more oligosaccharides to provide
both a satisfying
tactile or "mouth feel" and/or a pleasant flavor experience and manufacturing
workability,
including favourable rate of dissolution, low resulting viscosity in solution,
low temperature of
solidification and slow rate of solidification, without added sugars,
sweeteners, or sweetening
agents.
[00456] Further, in an embodiment, the buccal dosage forms comprising one or
more
oligosaccharides provide a more favourable dissolution profile compared to an
otherwise
identical buccal dosage forms except wherein the one or more oligosaccharides
is completely
replaced by one or more polysaccharides such as inulin and/or by sugar.
[00457] In an embodiment, the hard molded lozenge described herein can take
from about 5
minutes to about 25 minutes to dissolve when placed in a subject's mouth and
dissolved by
passive incubation in the oral cavity. In an embodiment, the hard molded
lozenge described
102
Date Recue/Date Received 2021-08-20

herein can take from about 8 minutes to about 20 minutes to dissolve when
placed in a subject's
mouth and dissolved by passive incubation in the oral cavity. In an
embodiment, about 60 to
about 90% of the lozenge dissolves after 20 minutes. One or more plasticizers
such as glycerin
and/ or one or more polysaccharides such as inulin as used herein may be used
to vary the rate
of dissolution.
III. Methods and Uses
[00458] The buccal dosage forms including hard molded lozenges, soft chew
lozenges an
compressed tablets of the application may, for example, be useful for the
treatment and
prevention of various diseases, disorders or conditions that benefit from
treatment with one or
more cannabinoids and/or cannabinoid extracts.
[00459] Accordingly, the present application also includes a method of
treating diseases,
disorders or conditions that benefit from treatment from one or more
cannabinoids and/or
cannabinoid extract, the method comprising administering a buccal dosage form
of the
application to a subject in need thereof.
[00460] The present application also includes a use of one or more buccal
dosage forms of the
application as described above for treating diseases, disorders or conditions
that benefit from
treatment from one or more cannabinoids and/or cannabinoid extract, as well as
a use of one or
more buccal dosage forms of the application for the preparation of a
medicament treating
diseases, disorders or conditions that benefit from treatment from one or more
cannabinoids
and/or cannabinoid extract. The application further includes a use of one or
more buccal dosage
forms of the application for use in treating diseases, disorders or conditions
that benefit from
treatment from one or more cannabinoids and/or cannabinoid extract.
[00461] In an embodiment, the one or more diseases, disorders or conditions
that benefit from
treatment one or more cannabinoids and/or cannabinoid extract is selected from
inflammatory
bowel disease (IBS), Crohn's disease(CD), irritable bowel syndrome (IBS),
ulcerative colitis (UC),
nausea, vomiting, anorexia, cachexia, pain including acute, chronic, and
neuropathic pain,
gastrointestinal tract distress, migraine headaches, postmenstrual syndrome
(PMS), cancer,
neurodegenerative diseases like Lou Gehrig's disease, Huntington's disease,
Alzheimer's
dementia, Parkinson's disease and Parkinsonian-type symptoms, spinal-cord
injuries; HIV/AIDS,
agitation, insomnia, depression, muscle spasms, spasticity from multiple
sclerosis, glaucoma,
Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder
(ADHD), Post-
Traumatic Stress Disorder (PTSD), and anxiety disorders.
[00462] In some embodiments, the subject is a mammal. In some embodiments, the
subject is
human.
[00463] Treatment methods comprise administering to a subject a buccal dosage
form of the
application that comprises a therapeutically effective amount of one or more
cannabinoids and/or
103
Date Recue/Date Received 2021-08-20

cannabinoid extract and optionally consist of a single administration, or
alternatively comprise a
series of administrations. For example, in some embodiments, the buccal dosage
form of the
application may be administered at least once a week. In some embodiments, the
buccal dosage
form may be administered to the subject from about one time per three weeks,
or about one time
per week to about once daily for a given treatment. In another embodiment, the
buccal dosage
forms are administered 2, 3, 4, 5 or 6 times daily. The length of the
treatment period depends on
a variety of factors, such as the severity of the disease, disorder or
condition, the age of the
subject, the concentration and/or the activity of the formulations of the
application, and/or a
combination thereof. It will also be appreciated that the effective dosage of
the buccal dosage
form used for the treatment may increase or decrease over the course of a
particular treatment
regime. Changes in dosage may result and become apparent by standard
diagnostic assays
known in the art. In some instances, chronic administration may be required.
For example, the
formulations are administered to the subject in an amount and for duration
sufficient to treat the
patient.
IV. Methods of Preparing
[00464] The present application also includes methods of preparing the buccal
dosage forms of
the application. In an embodiment, the buccal dosage form is a lozenge, such
as a hard molded
lozenge, a soft chew lozenge or a compressed tablet lozenge.
[00465] Accordingly, the present application includes a method of preparing
hard molded
lozenges of the application as described above comprising:
(a) mixing the one or more oligosaccharides with water to obtain an
oligosaccharide mixture;
(b) heating the oligosaccharide mixture to a suitable temperature until about
95% (w/w) to
about 99.9% (w/w) of the water is removed;
(c) cooling the oligosaccharide mixture to a suitable temperature;
(d) adding one or more cannabinoids, and/or a cannabinoid extract to the
oligosaccharide
mixture with mixing to obtain a bulk lozenge product; and
(e) shaping or molding the bulk lozenge product to form the hard molded
lozenges.
[00466] In an embodiment, when one or more plasticizers is present, the method
further
comprises adding one or more plasticizers with mixing to the cooled
oligosaccharide mixture in
step (d). Alternatively, in an embodiment, when one or more plasticizers are
present, the method
further comprises adding one or more plasticizers, all or in part, with
heating in step (b) prior to
reaching the suitable temperature.
[00467] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract are
heated before adding to the oligosaccharide mixture in step (d). In an
embodiment, the one or
more cannabinoids, and/or a cannabinoid extract are heated to about 65-85 C.
104
Date Recue/Date Received 2021-08-20

[00468] When one or more emulsifying agents are present and/or one or more
oils and/or fats
are present, then in an alternative embodiment, the method comprises (d)
mixing the one or more
cannabinoids, and/or a cannabinoid extract with the one or more emulsifying
agents and/or one
or more oils and/or fats to form a cannabinoid mixture, and adding the
cannabinoid mixture to
the to the oligosaccharide mixture to obtain a bulk lozenge product.
[00469] In an embodiment a suitable amount of water is used in step (a). In an
embodiment, a
suitable amount of water is an amount of water sufficient to dissolve the one
or more
oligosaccharides. In an embodiment, the suitable amount of water is about 25%
wt. to about 50%
wt, about 25% wt. to about 40% wt., about 30% wt. to about 40% wt. or about
30% wt. to about
35% wt. of the total weight of the one or more oligosaccharides.
[00470] In an embodiment, the oligosaccharide mixture is heated to a
temperature of about 280-
310 F. In an embodiment, the oligosaccharide mixture is heated for a time
sufficient to evaporate
substantially the entire amount of water. In the context of the present
application, "substantially
the entire amount of water" means about 5% (w/w) or less, about 4% (w/w) or
less, about 3%
(w/w) or less, about 2% (w/w) or less, or about 1% (w/w) or less of water to
the total mass of the
hard molded lozenge remains in the hard molded lozenge composition.
[00471] In an embodiment, when one or more polysaccharides is present, the
method further
comprises mixing the one or more polysaccharides with the one or more
oligosaccharides with
the water in step (a).
[00472] In the alternative, when only one or more polysaccharides are present,
step (a)
comprises mixing the one or more polysaccharides with water to obtain an
polysaccharides
mixture and step (b) to (e) are performed with the polysaccharides mixture.
[00473] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract is mixed
with the one or more emulsifying agents and/or one or more oils and/or fats to
form a
homogenous cannabinoid mixture.
[00474] In an embodiment, the method further comprises adding one or more
flavourants and/or
one or more pH modifying agents to the oligosaccharide mixture in step (d).
[00475] In an embodiment, the oligosaccharide mixture is cooled to about 260
to about 280 F.
[00476] In an embodiment, the bulk lozenge product is mixed to obtain a
homogenous bulk
lozenge product.
[00477] In an embodiment, the step of shaping or molding the bulk lozenge
product is by pouring
the bulk lozenge product into suitable molds. In an embodiment, the suitable
molds are silicone
molds. In an embodiment, the suitable molds are composed of rigid material
that is coated with
a non-stick coating. In an embodiment, the suitable molds are coated with a
suitable release
agent. In an embodiment, the method further comprises cooling the bulk lozenge
product to a
105
Date Recue/Date Received 2021-08-20

temperature suitable for shaping. In an embodiment, the temperature suitable
for shaping is
selected to be compatible with the shaping method.
[00478] In an embodiment, the step of shaping or molding the bulk lozenge
product is by
mechanical or manual shaping. In an embodiment, the mechanical shaping is
performed using a
rope former, drop roller press and/or pillow cutter. In an embodiment, the
manual shaping is by
folding, rolling and cutting the bulk lozenge product into desired shapes. In
an embodiment, the
step of shaping the bulk lozenge product is performed using a drop roller
press. In an
embodiment, when using a drop roller press, the bulk lozenge is cooled to a
temperature of about
70 C.
[00479] In an embodiment, the step of shaping or molding the bulk lozenge
product is performed
using a drop roller press to provide round hard molded lozenges.
[00480] In an embodiment, the step of shaping or molding the bulk lozenge
product is by pouring
the homogenous bulk lozenge product into a heated manual or mechanical
depositor system,
followed by depositing into suitable molds.
[00481] In an embodiment, the depositing into suitable molds is performed at a
suitable
temperature. In an embodiment, the suitable temperature for depositing is a
temperature that
provides a bulk lozenge product of suitable viscosity for dispensing the bulk
lozenge product from
a depositor. In an embodiment, the suitable temperature for depositing is
about 212 F to about
280 F.
[00482] In an embodiment, the method further comprises the step of finishing
the hard molded
lozenges. In an embodiment, the step of finishing comprises applying a
coating, deburring any
sharp edges, polishing and the like. In an embodiment, the polishing is
performed using a jewelry
tumbler.
[00483] In an embodiment, the present application includes hard molded
lozenges prepared by
the methods described above.
[00484] In an embodiment, the hard molded lozenges of the application are
hermetically sealed.
In an embodiment, the hard molded lozenges comprising a plasticizer are
packaged in blister
pack or heat-sealed pouch.
[00485] The Applicant has found that rework resulting form the preparation of
the hard lozenge
buccal dosage forms of the application can be simply and efficiently reheated
and remolded or
incorporated into a single new batch with essentially no loss of product.
Accordingly, the present
application also includes a method of reclaiming rework produced from
preparing the hard
molded lozenges of the application produced comprising:
heating the rework produced from preparing the hard molded lozenges of the
application to
a suitable temperature to melt the rework to provide a bulk lozenge product;
106
Date Recue/Date Received 2021-08-20

optionally cooling the bulk lozenge product to temperature suitable for
shaping; and
shaping or molding the bulk lozenge product to form the hard molded lozenges.
[00486] In an embodiment, the rework is heated to a temperature of about 70 C
to about 100 C,
80 C to about 100 C or about 90 C to about 100 C. In an embodiment, the rework
is heating
until melted. In an embodiment, the rework is heated until molten.
[00487] In an embodiment, the temperature suitable for shaping is as described
above for the
hard molded lozenges of the application.
[00488] In an embodiment, the shaping or molding of the bulk lozenge product
is as described
above for the hard molded lozenges of the application.
[00489] The present application also includes hard molded lozenges prepared by
the method of
reclaiming rework described above.
[00490] The present application also includes a method of preparing soft chew
lozenges of the
application as described above comprising:
(a) mixing the one or more gelling agents wherein the gelling agent is gelatin
with water and
allowing the gelling agent to hydrate to form a gelling mixture;
(b) adding the one or more oligosaccharides to the gelling mixture to obtain
an
oligosaccharide/gel mixture;
(c) heating the oligosaccharide/gel mixture;
(d) removing the oligosaccharide/gel mixture from the heat;
(e) adding one or more cannabinoids, and/or a cannabinoid extract to the
oligosaccharide/gel mixture to obtain a cannabinoid/oligosaccharide mixture
(f) mixing the cannabinoid/oligosaccharide mixture; and
(g) molding the homogenous cannabinoid/oligosaccharide mixture to form the
soft chew
lozenges.
[00491] When one or more emulsifying agents and/or one or more oils and/or
fats, then in an
alternative embodiment, the method comprises (d) mixing the one or more
cannabinoids, and/or
a cannabinoid extract to form a cannabinoid mixture, and the cannabinoid
mixture is added to
the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide mixture.
[00492] In an embodiment, the gelling agent is allowed to hydrate for about 10
minutes, about
20 minutes, about 30 minutes, about 40 minutes, about 50 minutes or about 60
minutes. In an
embodiment, the gelling agent is allowed to hydrate for about 30 minutes.
[00493] In an embodiment, the oligosaccharide/gelling mixture is heated to a
temperature of
about 30 C to about 60 C.
107
Date Recue/Date Received 2021-08-20

[00494] In an embodiment, the one or more polysaccharides is mixed with the
oligosaccharides
in step (b).
[00495] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract is mixed
with the one or more emulsifying agents and/or one or more oils and/or fats to
form a
homogenous cannabinoid mixture.
[00496] In an embodiment, the method further comprises adding one or more
flavourants and/or
one or more pH modifying to the oligosaccharide mixture in step (d).
[00497] In an embodiment, the cannabinoid/oligosaccharide mixture is mixed to
obtain a
homogeneous cannabinoid/oligosaccharide mixture.
[00498] In an embodiment, the step of shaping the cannabinoid/oligosaccharide
mixture is by
pouring the cannabinoid/oligosaccharide into suitable molds. In an embodiment,
the suitable
molds are silicone molds.
[00499] In an alternative embodiment, the present application also includes a
method for
preparing soft chew lozenges of the application as described above comprising:
(a) mixing one or more gelling agents wherein the gelling agent is gelatin
with water and
allowing the gelling agent to hydrate to form a gelling mixture;
(b) mixing the one or more oligosaccharides with water to obtain an
oligosaccharide
mixture;
(c) heating the oligosaccharide mixture;
(d) adding one or more cannabinoids, and/or a cannabinoid extract and the
gelling mixture
to the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide mixture
(e) mixing the cannabinoid/oligosaccharide mixture; and
(f) molding the cannabinoid/oligosaccharide mixture to form the soft chew
lozenges.
[00500] When one or more emulsifying agents is present and/or one or more oils
and/or fats is
present, then in an alternative embodiment, the method comprises (d) mixing
the one or more
cannabinoids, and/or a cannabinoid extract with one or more emulsifying agents
and/or one or
more oils and/or fats to form a cannabinoid mixture, and the cannabinoid
mixture is then added
to the to the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide
mixture.
[00501] In an embodiment, the gelling agent is allowed to hydrate for about 10
minutes, about
20 minutes, about 30 minutes, about 40 minutes, about 50 minutes or about 60
minutes. In an
embodiment, the gelling agent is allowed to hydrate for about 30 minutes.
[00502] In an embodiment, the oligosaccharide mixture is heated to a
temperature of about 30 C
to about 60 C.
108
Date Recue/Date Received 2021-08-20

[00503] In an embodiment, the one or more polysaccharides is mixed with the
one or more
oligosaccharides in step (b).
[00504] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract is mixed
with the one or more emulsifying agents and/or one or more oils and/or fats to
form a
homogenous cannabinoid mixture.
[00505] In an embodiment, the one or more emulsifying agent facilitates the
mixing of the one or
more cannabinoids, and/or a cannabinoid extract and the oligosaccharide
mixture thereby
improving the homogeneity of the cannabinoid mixture and/or
cannabinoid/oligosaccharide
mixture.
[00506] In an embodiment, the method further comprises adding one or more
flavourants and/or
one or more pH modifying to the oligosaccharide mixture in step (d).
[00507] In an embodiment, the cannabinoid/oligosaccharide mixture is mixed to
obtain a
homogenous cannabinoid/oligosaccharide mixture
[00508] In an embodiment, the step of shaping the homogenous
cannabinoid/oligosaccharide
mixture is by pouring the homogenous cannabinoid/oligosaccharide into suitable
molds. In an
embodiment, the suitable molds are silicone molds.
[00509] Soft chew lozenge of the present application comprising gelling agent
other than gelatin
can be prepared by processes known in the art. The selection of a particular
process to prepare
a soft chew lozenge of the present agent with a gelling agent other than
gelatin is within the
purview of the person of skill in the art.
[00510] In an embodiment, the present application includes soft chew lozenges
prepared by the
methods described above.
[00511] In an embodiment, the present application also includes a method of
preparing
compressed tablet lozenges of the application as described above comprising:
(a) combining the one or more cannabinoids, and/or the cannabinoid extract and
the one or
more oligosaccharides to obtain a cannabinoid/oligosaccharide mixture;
(b) mixing the cannabinoid/oligosaccharide mixture;
(c) adding the lubricant to the cannabinoid/oligosaccharide mixture and mixing
to obtain a
lubricated cannabinoid/oligosaccharide mixture,
(d) pressing the lubricated cannabinoid/oligosaccharide mixture to form the
compressed
table lozenges.
[00512] In an embodiment, the one or more cannabinoids, and/or a cannabinoid
extract is
warmed to a liquid state before combining with the one or more
oligosaccharides. In an
109
Date Recue/Date Received 2021-08-20

embodiment, the one or more cannabinoids, and/or a cannabinoid extract is
warmed to about 60
C to about 90 C.
[00513] When one or more emulsifying agents is present and/or one or more oils
and/or fats is
present, then in an alternative embodiment, the method comprises (a) mixing
one or more
cannabinoids, and/or a cannabinoid extract with one or more emulsifying agents
and/or one or
more oils and/or fats to form a cannabinoid mixture, and combining with about
10% (w/w) to
about 98% (w/w) of one or more oligosaccharides having a degree of
polymerization of about 2
to about 10 to obtain an cannabinoid/oligosaccharide mixture.
[00514] In an embodiment, the one or more polysaccharides is mixed with the
one or more
oligosaccharides in step (b).
[00515] In an embodiment, the cannabinoid/oligosaccharide mixture is mixed to
evenly disperse
the cannabinoid/oligosaccharide mixture.
[00516] In an embodiment, the method further comprises adding one or more
flavourants and/or
one or more pH modifying to the cannabinoid/oligosaccharide mixture.
[00517] In an embodiment, one or more buccal dosage forms of the application
as described
herein are packaged in a variety of conventional and non-conventional manners.
For example, a
plurality of buccal dosage forms can be packaged in a container having a lid.
In an embodiment,
a plurality of buccal dosage forms is stacked and packaged in a paper,
plastic, and/or aluminum
foil tube. In an embodiment, the packaging can have a child-resistant lid. In
an embodiment, the
buccal dosage forms of the application are packaged in a blister pack or foil
packet. In an
embodiment, the blister pack or foil pack is contained within child resistant
pouch. Accordingly,
in an embodiment, the present application further comprises a package
comprising one or more
buccal dosage forms of the application. In an embodiment, the buccal dosage
forms are selected
from one or more hard molded lozenges, soft chew lozenges and compressed
tablets and
combinations thereof.
[00518] In an embodiment, the present application includes compressed tablet
lozenges
prepared by the methods described above.
[00519] In an embodiment, the buccal dosage forms of the application are free
of added sugars,
sweeteners, and/or sweetening agents as described above.
[00520] In an embodiment, the buccal dosage forms of the application have less
stickiness
compared to an otherwise identical buccal dosage form except wherein the one
or more
oligosaccharides is replaced by sugar. Therefore, in an embodiment, the buccal
forms of the
application may be packaged without use of wrappers or a coating such as a
film or sugar coating.
[00521] The following non-limiting examples are illustrative of the present
application:
EXAMPLES
110
Date Recue/Date Received 2021-08-20

Example 1: Exemplary hard molded lozenge of the application
a) Exemplary hard molded lozenge composition ranges
Oligosaccharides (97%-99.9%)
Cannabis Extract (0.1-1%)
Emulsifying agents (0-1%)
Vegetable or animal fats/oils (0-1%)
Unsweetened Flavourants (0-1%)
b) Exemplary hard molded lozenge composition before manufacturing
fructo-oligosaccharide (150g),
water (33% w/w of fructo-oligosaccharide weight),
soy lecithin (0.15g),
fractionated coconut oil (0.75g),
cannabis distillate (0.75g),
peppermint oil (0.5g)
c) Manufacturing process
[00522] Cannabis distillate, soy lecithin and fractionated coconut oil were
combined in suitable
container and mixed until homogenous. Fructooligosaccharides(oligofructose)
and water were
combined in a heavy bottomed stainless-steel heating vessel fitted with
temperature probe. The
temperature of the fructooligosaccharide/water mixture was slowly raised to
about 280-310 F
and then removed from heat. Cannabis distillate mixture and remaining
ingredients were stirred
into the fructooligosaccharide/water mixture until homogenous. The
fructooligosaccharide/water
mixture was allowed first to cool to appropriate temperature if using
temperature sensitive
ingredients. For a molded lozenge, the final mixture was poured into suitable
molds (ex: Silicone)
(Figure 1). Alternatively, the final mixture was poured onto a work surface
and allow to cool until
malleable and then processed into desired shapes using manual handling
(folding, rolling,
cutting) or mechanical handling (rope former/size, drop roller press, pillow
cutter, etc.). The
lozenges were separated into individual pieces, sifted and tumbled to remove
small or undersized
lozenge pieces and packaged and stored in cool, dry location.
Example 2: Exemplary hard molded lozenge of the application optionally
comprising one
or more polysaccharides
a) Hard molded lozenge Composition
Oligosaccharides (10%-99.8%)
111
Date Recue/Date Received 2021-08-20

Polysaccharides (0A-899%)
Cannabis Extract (0.1-1%)
Emulsifying agents (0-1%)
Vegetable or animal fats/oils (0-1%)
Unsweetened Flavourants (0-1%)
pH modifying agents (0-0.1)
b) Manufacturing process
[00523] In a heavy bottom stainless-steel heating vessel (or other suitable
heating vessel),
fructooligosaccharides (oligofructose) [exemplary oligosaccharide (10-99.8%)],
I nulin [exemplary
polysaccharide (0A-899%)] and water are combined and heated until the
temperature of the
mixture reaches about 280-310 F. The fructooligosaccharide solution is removed
from heat and
the cannabis extract (0.1-1%) and any remaining ingredients (for example,
unsweetened
flavouring agent, 0-1%) are added and mixed until homogenous. The resulting
liquid is shaped
by pouring into suitable molds to cool (ex: Silicone). Alternatively, the
liquid is poured onto a work
surface to cool until malleable then processed into desired shapes using
manual (folding, rolling,
cutting) or mechanical handling (rope former/sizer, drop roller press, pillow
cutter, etc). Once
cooled to room temperature, lozenges were separated into individual pieces,
sifted/tumbled to
remove small or undersized pieces (as required) and packaged/stored in a cool,
dry location.
Example 3: Exemplary Hard molded lozenge of the Application optionally
comprising one
or more emulsifying agents
a) Hard molded lozenge Composition
Oligosaccharides (10%-99.8%)
Polysaccharides (OA-899%)
Cannabis Extract (0.1-1%)
Emulsifying agents (0-1%)
Vegetable or animal fats/oils (0-1%)
Unsweetened Flavourants (0-1%)
pH modifying agents (0-0.1)
b) Manufacturing process
[00524] Cannabis extract (0.1-1%) and soy lecithin (exemplary emulsifier (0-
1%)) are combined
in a suitable container and mixed until homogenous. In a heavy bottom
stainless-steel heating
vessel (or other suitable heating vessel), Fructooligosaccharide/oligofructose
(exemplary
oligosaccharide (10%-99.8%)), Inulin (exemplary polysaccharide (0.1-90%)) and
water are
1 1 2
Date Recue/Date Received 2021-08-20

combined and heated until the temperature of the mixture reaches 280-310 F.
The
fructooligosaccharide solution is removed from heat and the cannabis extract
solution and any
remaining ingredients (for example, unsweetened flavouring agent, 0-1%) are
added and mixed
until homogenous. The resulting liquid is shaped by pouring into suitable
molds to cool (ex:
Silicone). Alternatively, the liquid is poured onto a work surface to cool
until malleable then
processed into desired shapes using manual (folding, rolling, cutting) or
mechanical handling
(rope former/sizer, drop roller press, pillow cutter, etc.). Once cooled to
room temperature,
lozenges were separated into individual pieces, sifted/tumbled to remove small
or undersized
pieces (as required) and packaged/stored in a cool, dry location.
Example 4: Exemplary hard molded lozenge of the application optionally
comprising one
or more emulsifying agents and one or more oils/fats
a) Hard molded lozenge Composition
Oligosaccharides (10%-99.8%)
Polysaccharides (OA-899%)
Cannabis Extract (0.1-1%)
Emulsifying agents (0-1%)
Vegetable or animal fats/oils (0-1%)
Unsweetened Flavourants (0-1%)
pH modifying agents (0-0.1%)
b) Manufacturing process
[00525] Cannabis extract (0.1-1%), soy lecithin (exemplary emulsifier (0-1%)),
and fractionated
coconut oil (Vegetable or animal fat/oil (0-1%)) are combined in a suitable
container and mixed
until homogenous. In a heavy bottom stainless-steel heating vessel (or other
suitable heating
vessel), Fructooligosaccharide (oligofructose) [exemplary oligosaccharide (10%-
99.8%)], Inulin
[exemplary polysaccharide (0.1-89.9%)] and water are combined and heated until
the
temperature of the mixture reaches about 280-310 F. The fructooligosaccharide
solution was
removed from heat and the cannabis extract solution and any remaining
ingredients (ex:
unsweetened flavouring agent, 0-1%) were added and mixed until homogenous. The
resulting
liquid is shaped by pouring into suitable molds to cool (ex: Silicone).
Alternatively, the liquid is
poured onto a work surface to cool until malleable then processed into desired
shapes using
manual (folding, rolling, cutting) or mechanical handling (rope former/sizer,
drop roller press,
pillow cutter, etc.). Once cooled to room temperature, lozenges are separated
into individual
pieces, sifted/tumbled to remove small or undersized pieces (as required) and
are
packaged/stored in a cool, dry location.
1 1 3
Date Recue/Date Received 2021-08-20

Example 5: Exemplary hard molded lozenge of the application optionally
comprising one
or more oils/fats
a) Hard molded lozenge Composition
Oligosaccharides (10%-99.8%)
Polysaccharides (0A-899%)
Cannabis Extract (0.1-1%)
Emulsifying agents (0-1%)
Vegetable or animal fats/oils (0-1%)
Unsweetened Flavourants (0-1%)
pH modifying agents (0-0.1)
b) Manufacturing process
[00526] Cannabis extract and fractionated coconut oil [exemplary vegetable or
animal fat/oil (0-
1%)] are combined in a suitable container and mixed until homogenous. In a
heavy bottom
stainless-steel heating vessel (or other suitable heating
vessel),
Fructooligosaccharide/oligofructose [exemplary oligosaccharide (10%-99.8%)],
Inulin
[exemplary polysaccharide (OA-899%)] and water are combined and heated until
the
temperature of the mixture reaches 280-310 F. The fructooligosaccharide
solution is removed
from heat and the cannabis extract mixture and any remaining ingredients (for
example,
unsweetened flavouring agent, 0-1%) are added and mixed until homogenous. The
resulting
liquid is shaped by pouring into suitable molds to cool (ex: Silicone).
Alternatively, the liquid is
poured onto a work surface to cool until malleable then processed into desired
shapes using
manual (folding, rolling, cutting) or mechanical handling (rope former/sizer,
drop roller press,
pillow cutter, etc.). Once cooled to room temperature, lozenges are separated
into individual
pieces, sifted/tumbled to remove small or undersized pieces (as required) and
are
packaged/stored in a cool, dry location
Example 6: Exemplary soft chew lozenge of the application
a) Exemplary soft chew lozenge composition ranges
Water (10-20%)
Oligosaccharides (70%-90%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-5%)
Vegetable oils and/or animal fats (0-5%)
Gelling agents (1-10%)
114
Date Recue/Date Received 2021-08-20

Flavourants (0-2%)
pH control agents (0-2%).
b) Exemplary soft chew lozenge composition before manufacturing
Water (150g)
fructooligosaccharides (745g),
gelatin (60g)
citric acid (20g)
cannabis distillate (10g)
fractionated coconut oil (10g)
soy lecithin (5g)
c) Manufacturing process
[00527] Gelatin and water were combined and set aside to hydrate for 30
minutes.
Fructooligosaccharides and remaining water were combined in a suitable vessel
and heated with
mixing to dissolve fructooligosaccharides (temperature was maintained between
about 30-60 C).
Soy lecithin, fractionated coconut oil and cannabis distillate were combined
in a separate
container and mixed until homogenous. Lecithin/Oil/cannabis extract solution
was mixed into
fructooligosaccharide solution and homogenized. Gelatin solution was added to
the mixture and
combined until homogenous. Citric acid was added. Final mixture was poured
into suitable molds
(ex: silicone) and allow to set before removing from molds and packaging
(Figure 1).
Example 7: Exemplary soft chew lozenge of the application optionally
comprising one or
more polysaccharides
a) Exemplary soft chew lozenge composition ranges
Water (10-70%)
Oligosaccharides (10%-90%)
Polysaccharides (0%-80%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-5%)
Vegetable oils and/or animal fats (0-5%)
Gelling agents (1-10%)
Flavourants (0-2%)
pH modifying agent (0-2%).
115
Date Recue/Date Received 2021-08-20

b) Manufacturing process
[00528] Gelatin [exemplary gelling agent (1-10%)] and water are combined in a
suitable container
and set aside to hydrate for 30 minutes. In a suitable heating vessel,
fructooligosaccharide/oligofructose [exemplary oligosaccharide (10%-90%)],
!nulin [exemplary
polysaccharide (0-80%)] and the gelatin solution are combined and heated with
mixing until all
components are dissolved while maintaining temperature below boiling, after
which the mixture
is removed from heat. Cannabis extract (0.25-1%) and all remaining ingredients
(for example,
unsweetened flavouring agent, 0-2%) were combined with the oligosaccharide and
gelatin
solution and mixed until homogenous. Resulting liquid is poured into suitable
molds (ex: silicone,
starch molds, etc.) and allowed to set before removing from molds and
packaging.
Example 8: Exemplary soft chew lozenge of the application optionally
comprising one or
more polysaccharides and one or more emulsifying agents
a) Exemplary soft chew lozenge composition ranges
Water (10-70%)
Oligosaccharides (10%-90%)
Polysaccharides (0%-80%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-5%)
Vegetable oils and/or animal fats (0-5%)
Gelling agents (1-10%)
Flavourants (0-2%)
pH modifying agents (0-2%).
b) Manufacturing process
[00529] Gelatin [exemplary gelling agent (1-10%)] and water are combined in a
suitable container
and set aside to hydrate for 30 minutes. In a separate container, cannabis
extract (0.25-1%) and
soy lecithin [exemplary emulsifier (0-5%)] are mixed until homogenous. In a
suitable heating
vessel, fructooligosaccharide/oligofructose [exemplary oligosaccharide (10%-
90%)], I nulin
[exemplary polysaccharide (0-80%)] and the gelatin solution are combined and
heated with
mixing until all components are dissolved while maintaining temperature below
boiling, after
which the mixture was removed from heat. The cannabis extract and lecithin
mixture as well as
all remaining ingredients (ex: unsweetened flavouring agent, 0-2%) are
combined with the
oligosaccharide and gelatin solution and mixed until homogenous. Resulting
liquid is poured into
suitable molds (ex: silicone, starch molds, etc.) and allowed to set before
removing from molds
and packaging.
116
Date Recue/Date Received 2021-08-20

Example 9: Exemplary soft chew lozenge of the application optionally
comprising one or
more polysaccharides, one or more emulsifying agents and one or more oils/fats
a) Exemplary soft chew lozenge composition ranges
Water (10-70%)
Oligosaccharides (10%-90%)
Polysaccharides (0%-80%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-5%)
Vegetable oils and/or animal fats (0-5%)
Gelling agents (1-10%)
Flavourants (0-2%)
pH modifying agent (0-2%).
b) Manufacturing process
[00530] Gelatin [exemplary gelling agent (1-10%)] and water are combined in a
suitable container
and set aside to hydrate for 30 minutes. In a separate container, cannabis
extract (0.25-1%), soy
lecithin [exemplary emulsifier (0-5%)] and fractionated coconut oil [exemplary
vegetable oils
and/or animal fats (0-5%)] are mixed until homogenous. In a suitable heating
vessel,
fructooligosaccharide/oligofructose [exemplary oligosaccharide (10%-90%)],
!nulin [exemplary
polysaccharide (0-80%)] and the gelatin solution are combined and heated with
mixing until all
components are dissolved while maintaining temperature below boiling, after
which the mixture
is removed from heat. The cannabis extract, lecithin, and fractionated coconut
oil mixture as well
as all remaining ingredients (ex: unsweetened flavouring agent, 0-2%) are
combined with the
oligosaccharide and gelatin solution and mixed until homogenous. Resulting
liquid is poured into
suitable molds (ex: silicone, starch molds, etc.) and allowed to set before
removing from molds
and packaging.
Example 10: Exemplary soft chew lozenge of the application optionally
comprising one or
more polysaccharides and one or more oils/fats
a) Exemplary soft chew lozenge composition ranges
Water (10-70%)
Oligosaccharides (10%-90%)
Polysaccharides (0%-80%)
Cannabis Extract (0.25-1%)
117
Date Recue/Date Received 2021-08-20

Emulsifiers (0-5%)
Vegetable oils and/or animal fats (0-5%)
Gelling agents (1-10%)
Flavourants (0-2%)
pH modifying agent (0-2%).
b) Manufacturing process
[00531] Gelatin [exemplary gelling agent (1-10%)] and water are combined in a
suitable container
and set aside to hydrate for 30 minutes. In a separate container, cannabis
extract (0.25-1%) and
fractionated coconut oil [exemplary vegetable oils and/or animal fats (0-5%)]
are mixed until
homogenous. In a suitable heating vessel, fructooligosaccharide/oligofructose
[exemplary
oligosaccharide (10%_900,io)]¨,
!nulin [exemplary polysaccharide (0-80%)] and the gelatin solution
are combined and heated with mixing until all components are dissolved while
maintaining
temperature below boiling, after which the mixture is removed from heat. The
cannabis extract
and fractionated coconut oil mixture as well as all remaining ingredients (ex:
unsweetened
flavouring agent, 0-2%) are combined with the oligosaccharide and gelatin
solution and mixed
until homogenous. Resulting liquid is poured into suitable molds (ex:
silicone, starch molds, etc.)
and allowed to set before removing from molds and packaging.
Example 11: Exemplary compressed tablet lozenge of the application
a) Exemplary compressed tablet lozenge composition ranges
Ingredient composition range:
Oligosaccharides (10%-98%)
Polysaccharides (0-88%)
Lubricants (1-5%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-0.5%)
Vegetable or animal fats/oils (0-1%)
Unsweetened flavoring agents (0-1%)
Acidifying agents (e.g., citric acid and/or malic acid and/or tartaric acid, 0-
0.1%)
b) Manufacturing process
[00532] Cannabis extract (0.25-1%) is warmed until it reaches a free-flowing
liquid state. In a
suitable mixing vessel, fructooligosaccharide/oligofructose [exemplary
oligosaccharide (10%-
98%)], !nulin [exemplary polysaccharide (0-88%)] and warmed cannabis extract
are combined
118
Date Recue/Date Received 2021-08-20

and mixed until evenly dispersed, followed by any unsweetened flavouring agent
(0-1%) and
acidifying agent (0-0.1%). Once combined, magnesium stearate [exemplary
lubricant, 1-5%] is
added and mixed until evenly dispersed throughout the batch before pressing
the resulting
powder into tablets.
Example 12: Exemplary compressed tablet lozenge of the application optionally
comprising one or more emulsifying agents and one or more oils/fats
a) Exemplary compressed tablet lozenge composition ranges
Ingredient composition range:
Oligosaccharides (10%-98%)
Polysaccharides (0-88%)
Lubricants (1-5%)
Cannabis Extract (0.25-1%)
Emulsifiers (0-0.5%)
Vegetable or animal fats/oils (0-1%)
Unsweetened flavoring agents (0-1%)
Acidifying agents (e.g., citric acid and/or malic acid and/or tartaric acid, 0-
0.1%)
b) Manufacturing process
[00533] Cannabis extract (0.25-1%), soy lecithin [exemplary emulsifier (0-
0.5%)], and
fractionated coconut oil [exemplary vegetable or animal fat/oil (0-1%)] are
combined in a suitable
container and mixed until homogenous. In a suitable mixing vessel,
fructooligosaccharide/oligofructose [exemplary oligosaccharide (10%-98%)],
Inulin [exemplary
polysaccharide (0-88%)] and cannabis extract mixture are combined and mixed
until evenly
dispersed, followed by any unsweetened flavouring agent (0-1%) and acidifying
agent (0-0.1%).
Once combined, magnesium stearate [exemplary lubricant, 1-5%] are added and
mixed until
evenly dispersed throughout the batch before pressing the resulting powder
into tablets.
Example 13: Exemplary Hard molded lozenge of the Application comprising a
plasticizer
a) Exemplary hard molded lozenge composition
Orafti P95 (fructo-oligosaccharide) 92.14%
Glycerin 5%
Cannabis Extract 1.059% (80% potency)
Peppermint oil 0.7 %
119
Date Recue/Date Received 2021-08-20

Lecithin 0.10
Residual water 1%
[00534] The cannabis extract comprises THC. The final exemplary hard molded
lozenge
comprised about 10mg of THC.
b) Manufacturing process
[00535] The fructo-oligosaccharide (OraftiO P95) was mixed with a suitable
amount of water to
dissolve the oligosaccharide. While mixing, the mixture was heated to about
280-310 F.
[00536] The heating was stopped once the temperature of about 280-310 was
reached. The
cold glycerin was added to the oligosaccharide mixture with mixing to stop
cooking process. The
cooked oligosaccharide mixture was cooled to about 260-280 F.
[00537] Separately the cannabinoids and/or cannabinoid extracts were heated to
about 65-85 C
and the optional emulsifiers (e.g., lecithin) and flavouring were added.
[00538] While still hot, the cannabinoids mixture was mixed with the cooked
oligosaccharide
mixture to provide a hot bulk lozenge product (slab).
[00539] The hot bulk lozenge product was portioned and shaped or molded into
individual hard
molded lozenges. The hot bulk lozenge product can be portioned and shaped or
molded by
depositing it into molds using a depositor machine, or by partially cooling
the mixture to malleable
state (wherein the temperature of the bulk lozenge product > room temperature)
and
mechanically shaping or portioning using a drop roller machine, rope
former/cutter and the like.
[00540] Figure 2 shows the hot bulk lozenge product that was portioned and
sized using a drop
roller machine at about 70 C. Figure 2 A is a picture showing a slab of formed
hard molded
lozenges using a drop roller machine.
[00541] Once cooled to room temperature the shaped product was separated and
any post
processing steps such as applying an optional coating, deburring any sharp
edges, polishing and
the like can be performed if necessary. Figure 2 B is a picture showing
individual hard molded
lozenge produced using a drop roller machine after they have been cooled,
separated and
polished using a jewelry tumbler.
[00542] Each hard molded lozenge comprised about 10mg THC.
[00543] The hard molded lozenges were package and stored in hermetic
containers until ready
for packaging.
c) Rework Product
120
Date Recue/Date Received 2021-08-20

[00544] All rework from all batches was collected and placed in a pan and
heated in an oven to
about 100 C. Once the all the rework was melted the temperature was reduced to
about 70 C
to provide a hot bulk lozenge product suitable for use in a hot roller press.
The recovered bulk
lozenge product was portioned and shaped or molded as described in Example 13
(b) above.
Example 14: Crystallization study
[00545] Various bulk lozenge product compositions were prepared having an
otherwise similar
composition to the hard molded lozenge composition of Example 13 except the
amount of
oligosaccharide and glycerin was replaced with a combination of sugar and
glucose; fructo-
oligosaccharide alone; fructo-oligosaccharide and inulin; or fructo-
oligosaccharide, inulin and
glycerin; as described in Table I. The bulk lozenge product of each
composition was placed in
an oven at 90 C for 20 minutes and then visually inspected for
crystallization.
Table 1: Crystallization Study data
Composition Observations
3 Parts Sugar: very crystallized;
1 Part Glucose Syrup unusable for molding
2 Parts Sugar Very crystallized;
1 Part Glucose Syrup
unusable for molding
fructo-oligosaccharide alone Suitable for molding once cooled to lower
temperature (about 70 C)
3 Parts fructo- Suitable for molding
oligosaccharide
1 Part Inulin
4.5 Parts FOS Suitable for moldingonce cooled to lower
4.5 Parts Inulin temperature (about 70 C)
1 Part Glycerin
[00546] The crystallization data in Table 1 shows that lozenges comprising FOS
alone, FOS plus
glycerin, inulin plus glycerin, FOS plus inulin, and FOS, inulin, plus
glycerin all generated a
finished good that is completely resistant to crystallization. Moreover, these
products can be
brought back to either malleable or liquid state by heating the material to
appropriate
temperatures and this, as many times as is required by the workflow or
manufacturing process
on hand.
[00547] By contrast, the data in Table 1 showed that traditional sugar-based
lozenges are prone
to crystallization, occurring during cooling to malleable state after cooking
or holding at malleable
state while waiting for further processing. This propensity to crystallization
makes the sugar
121
Date Recue/Date Received 2021-08-20

manufacturing process much less forgiving in general and as described below,
less
accommodating of rework.
Example 15: Rework study
[00548] Exemplary hard molded lozenges were prepared having an otherwise
similar
composition to the hard molded lozenge composition of Example 13 except the
amount of
oligosaccharide and glycerin was replaced with a combination of sugar and
glucose, fructo-
oligosaccharide alone; fructo-oligosaccharide and inulin; fructo-
oligosaccharide, inulin and
glycerin; and inulin and glycerin as noted in Table 2.
[00549] To determine the minimum required temperature required to re-work the
exemplary hard
molded lozenges, cooled and hardened lozenges were placed in a heated vessel
and
progressively warmed until completely melted into a continuous viscous liquid.
At this stage, the
material was cooled to a temperature allowing appropriate malleability before
molding via
traditional processes (drop rolling, pillow cutters, rope formers, etc).
Observations in regard to
reworkability were made as shown in table 2.
Table 2
Minimum
Glucose temperature
Lozenge FOS (% Inulin(% Glycerin (% Sugar Syrup(% required for
re-
I.D Total) Total) Total) (% Total) Total) work
process
Crystallization
upon melting, no
A - - 75 25 rework possible
Crystallization
upon melting, no
B - - 66 33 rework possible
C 100 0 0 - 110 C
D 100 0 2.5 - 100 C
E 100 0 5 - 90 C
F 100 0 10 - 80 C
H 75 25 0 - 110 C
I 50 50 0 - 120 C
J 50 50 5 - 110 C
K 50 50 10 - 90 C
L 50 50 15 - 80 C
N 0 100 0 - -
O 0 100 5 - 120 C
P 0 100 10 - 100 C
Q 0 100 15 - 90 C
[00550] Reworking via melting and reshaping of lozenges requires product to
reach completely
molten state. Results in table 2 highlight the inability of traditional sugar
candies to be reworked
via re-melting as both samples A and B immediately crystallised upon reaching
a molten state,
122
Date Recue/Date Received 2021-08-20

negating any opportunity to remold the material. The impact of Glycerin on the
minimum
temperature requirements for re-work (= temperature to reach completely molten
state) is evident
in comparing samples C through F, I through L, and N through Q, respectively,
as increasing
glycerin concentration corresponds with progressively lower temperature
requirements for
melting. Ratios of FOS:Inulin also show clearly that higher % FOS lozenges
require lower
processing temperatures to reach molten state compared with their higher % I
nulin counterparts
(comparing E, J, and 0, for example). Taken together, these results show the
advantage of FOS,
FOS:Inulin, or !nulin lozenges, with or without additional glycerin, to be
amenable to rework
through thermal processing to molten state whereas traditional candy products
(sugar based)
cannot be reworked in this fashion. Furthermore, it shows the tunability of
these properties via
I nulin:FOS:Glycerin ratios.
Example 16: Mouth feel study
Various hard molded lozenge compositions having an otherwise similar
composition to the hard
molded lozenge composition of Example 13 except the amount of glycerin was
varied as
described in the Table 3 below were prepared.
[00551] The texture and quality of the hard molded lozenges comprising an
increasing
concentration of glycerin that were portioned and shaped by drop roller as
described in Example
13 and then cooled to ambient temperature was observed and described in Table
3.
Table 3
Glycerin concentration (%)
0 2.5 5 10 15 20
Stickiness (surface)
Flex +++
Indentation +++
Stick to teeth ++ +++
[00552] It was noted that both flexibility of material as well as indentation
when probing with sharp
tool started to occur at 15% glycerin, increasing at 20% significantly.
[00553] In addition to these observations, it was also noted that any
formulation comprising
>10% glycerin caused sticking to teeth, which progressively worsened as the
concentration of
glycerin was increased.
Example 17: Fresh material malleability study
a) Physical observations of material at various oven holding temperatures
123
Date Recue/Date Received 2021-08-20

[00554] Exemplary hard molded lozenges were prepared having an otherwise
similar
composition to the hard molded lozenge composition of Example 13 except the
amount of
oligosaccharide and glycerin was replaced with fructo-oligosaccharide, fructo-
oligosaccharide
and inulin and with or without glycerin, or sugar and glucose as noted in
Table 4. The lozenges
were cooked to about 281 F and 295 F for sugar candies (slightly higher
temperature due to
higher temperature required to reach "hard crack" stage for sugar) then
equilibrated to prescribed
temperatures in Table 4 in oven and physical observations were noted. In Table
4, "3" means
liquid, "2" means malleable, "1" means rolled and "0" means solid.
Table 4
Formulations
FOS FOS FOS FOS FOS 4.5:4.5:1 2:1 3:1
FOS glycer glyc glyc glyc glyc 1:1 3:1 FOS: Sugar: Sugar:
Temp glycer in erin erin erin erin FOS:
FOS: lnulin: Glucose Glycose
( C) in 0% 2.5% 5% 10% 15% 20% lnulin lnulin Glycerol
syrup syrup
100 2 2 2 2 3 3 2 2 3 3 2
90 2 2 2 2 2 3 1 2 2 2 1
80 2 2 2 2 2 3 0 1 2 1 0
70 1 1 2 2 2 3 0 0 2 0 0
65 0 2 1 2 2 2 0 0 1 0 0
60 0 0 2 1 2 2 0 0 0 0 0
55 0 0 0 2 2 2 0 0 0 0 0
50 0 0 0 0 1 2 0 0 0 0 0
45 0 0 0 0 2 2 0 0 0 0 0
23 0 0 0 0 0 2 0 0 0 0 0
[00555] In the FOS+glycerin lozenge formulations it was observed that with
each increase in
glycerin, there was a progressive decrease in temperature for the transition
from liquid to
malleable, as well as in the required temperature for drop roller performance
to the point where
glycerin at 20% does not allow for proper manipulation, even at room
temperature. By adding
inulin either 1:1 or 3:1 FOS:Inulin a higher workable temperature was
observed, indicating a
higher Tg. Adding in glycerin at 10% w/w to a 1:1 formulation of FOS:Inulin
significantly reduced
that temperature, and looked similar to the 5% glycerin formulation in terms
of temperature of
manipulation. Surprisingly, both 2:1 and 3:1 sugar candy formulations
crystallized/hardened very
early on. This is different from Tg as the molecular arrangement is
dissimilar, however this
showed the poor overall workability of sugar candy (even with fresh material)
when compared to
FOS and/or Inulin formulations. As noted in other examples (e.g Example 15),
reaching "rollable"
state with rework sugar material was not possible.
124
Date Recue/Date Received 2021-08-20

b) Workable temperatures as a function of glycerin concentration
[00556] Using data from Table 4, Figure 3 shows in graph form the progression
of appropriate
drop roller manipulation temperature of exemplary formulas based on
concentration of glycerin
present and comparative traditional sugar candy combinations. A reduced
working temperature
(Le., easier manufacturing) was observed as the glycerin concentration was
increased. Without
being bound by theory, this is directly related to the modulation of the glass
transition temperature
by glycerin inclusion. 20% glycerin concentration was not shown since the
material was tacky
and could not be run through the drop roller. 0% glycerin formulations rolled
at 70 C but required
fast manipulation in transitioning from the oven to the drop roller to avoid
heat-sink too quickly
on the stainless-steel drop roller barrels. Cleaner impressions were observed
with 2.5%
additional glycerin. The overall highest working temperatures (Le., most
difficult) were found to
be formulations of 1:1 FOS:Inulin as well as traditional sugar candies. The
former is potentially
due to longer chain length of I nulin inclusion, increasing Tg. The latter did
not reach Tg at all but
rather crystallized in situ
[00557] FOS:I nulin (1:1) with 10% glycerin formulations were found to react
similar to FOS with
0% glycerin, which indicated, to a certain extent, the reduction of
workability caused by adding
in inulin can be reversed by addition of an appropriate concentration of
glycerin to the final
formulation.
c) Viscosity as a function of temperature at varying glycerin concentrations
The viscosity of a material describes its resistance to deformation, or its
"thickness". Typical
lozenge manufacturing can require pumping/injection of molten lozenge material
for the product
to be transferred, accurately metered, injected into molds, etc. Viscosity of
hard molded lozenges
compositions having an otherwise similar composition to the hard molded
lozenge composition
of Example 13 except the amount of glycerin was varied was measured with a
heating device
equipped Rotational Rheometer (RheolabQC) using a concentric cylinder
measuring system
(CC10). Figure 4 is a graph (expressed in log scale cP) showing glycerin's
ability to reduce the
temperature dependant viscosity of hard molded lozenges comprising fructo-
oligosaccharide
(FOS lozenges) a function of the glycerin concentration. It was found that the
addition of glycerin
provided an improved quality in manufacturing (e.g., improved dispensing,
metering, pumping,
molding) and by extension, improved quality in composition (e.g., limited
product breakdown due
to thermal abuse and improved lozenge moldability
[00558] As an extension, material formulated with a high proportion of
polysaccharides (e.g,
inulin) exhibit much higher viscosity at a given temperature than their FOS
counterparts. This
viscosity can however reduce to reasonable ranges (in line with 0-5%
glycerin/FOS lozenges)
with the addition of proportionally higher concentration of glycerin as a
plasticizer (see FOS:Inulin
(1:1) ¨ 10% Glycerin curve in figure 4). It is noted that traditional hard-
candy material (formulated
from sucrose and glucose syrup) cannot be effectively assayed for viscosity
using this apparatus
125
Date Recue/Date Received 2021-08-20

as the warm fluid material rapidly crystalizes and blocks rotational movement
within the
Rheometer.
Example 18: Dissolution study: Dissolution time of exemplary lozenges based on
concentration modulation of glycerin
[00559] Exemplary hard molded lozenges were prepared that had an otherwise
similar
composition to the exemplary molded lozenge composition of Example 13 except
the amount of
oligosaccharide (FOS) was varied and various
combination of
oligosaccharide(FOS)/polysaccharide (inulin) was used and increasing glycerin
concentrations
(0, 2.5, 5, 10, 15 and 20%) were included. The dissolution time of the various
lozenges was
tracked with a modified version of lozenge dissolution testing previously
described in literature
(Koland M, Charyulu RN, Vijayanarayana K, Prabhu P. In vitro and in vivo
evaluation of chitosan
buccal films of ondansetron hydrochloride. Int J Pharm Investig. 2011
Jul;1(3):164-71) using
simulated salivary fluid (SSF). Reaction was run at 37 C using temperature-
controlled water
recirculatory and jacketed beaker sitting on top of a stir-plate using
magnetic stir bar at 400RPM
for constant SSF turnover and mixing. Exemplary Lozenge samples sat in
suspended metal
mesh cup.
[00560] Figure 5 shows a clear reduction of dissolution time as glycerin
concentration was
increased in final formulation. There exists an inflection point here when
moving beyond 10%
glycerin. This inflection concurs with teeth stickiness as noted above adding
validity to the
hypothesis that the increased glycerin concentration at beyond e.g 10% induces
a Tg at
approximately body temperature of 37 C, causing a physical property change of
Ingot material.
[00561] Table 5 shows the dissolution in descending order of time
Table 5
126
Date Recue/Date Received 2021-08-20

Dissolution in descending
order of time
inullin Glycerol 0%
inuilin Glycerol 5%
tin Glycerol 10%
inulin GI ceroB 15%
,1;1. FOSAnulin
1:1 FOS:Inulin 5% Glycerol
,3:1 FOS:Moulin
Inulin Glycerol 20%
ilL FOS Inulin 10% Glycerol
1;1. F05:Inulin 15%, Glycerol
FOS ,Glycevol
FOS Glycerol 2.5%
FOS Glycerol 5%
FOS Glycerol 10%
3:1 51.1 ar2GS
2;1 Sugar: GS
,1 ;1 FOS:Inulin 20% Glycerol
FO:S Glycerol 15%
FOE Glycerol 20%
[00562] Including Inulin into FOS formulations was found to increase
dissolution time
significantly, concurring with observations of increased Tg above. Adding 10%
glycerin to 1:1
FOS:Inulin formulation again caused lozenge to react in a similar way to FOS
alone; and when
comparing 1:1 FOS: Inulin, FOS:Inulin + 10% glycerin and FOS 10% glycerin it
was noted that
the addition of glycerin allowed for a partial reversion of Inulin:FOS
dissolution time, but it did not
reach the observed dissolution times for FOS+10% glycerin alone ¨ a trend
which was observed
to hold true across comparisons between the FOS + glycerin and FOS + Inulin +
glycerin groups.
Therefore, dissolution rate can be tuned by using either glycerin to shorten
or inulin to lengthen
overall dissolution time. Additionally, inulin lozenges may be valuable in
active pharmaceutical
ingredient (API) delivery where oromucosal active pharmaceutical ingredient
delivery is less
efficient, such as in cannabis since Inulin lozenges have overall longer
dissolution times. It was
observed that the dissolution time of traditional sugar candies is quite short
at around 10:50
required for complete dissolution. The closest approximation of dissolution
time in FOS lozenges
is at 10% glycerin, with a dissolution time of 11:05, however FOS lozenges at
5% is not far off
coming in at 11:36. Similar dissolution time can be reached in inulin
formulations, however a
higher overall concentration of glycerin is required, reaching 20%+ glycerin
in final formulation.
These similar dissolution times shows the use of glycerin in the FOS lozenges
allows for a closer
127
Date Recue/Date Received 2021-08-20

overall experience to traditional sugar candies for dissolution, rapid API
delivery, and consumer
experience.
Example 19: Dissolution study of exemplary lozenges with inulin
[00563] Various exemplary hard molded lozenge compositions were prepared
having an
otherwise similar composition to the hard molded lozenge composition of
Example 13 except the
amount of fructo-oligosaccharide and glycerin was replaced with a combination
of fructo-
oligosaccharide and inulin. Figure 6 shows that the dissolution time increases
with increasing
amounts of inulin.
Example 20: Exemplary hard molded lozenge of the application comprising a
plasticizer
and a polysaccharide
a) Exemplary hard molded lozenge composition
(inulin) 92.14%
Glycerin 5%
Cannabis Extract 1.059% (80% potency)
Peppermint oil 0.7%
Lecithin 0.1
Residual water 1%
b) Manufacturing process
[00564] The hold molded lozenge of Example 20 (a) was prepared following the
method
described in Example 13 (b).
Example 21: Exemplary hard molded lozenge of the application comprising a
plasticizer
and a mixture of a oligosacharide and a polysaccharide
a) Exemplary hard molded lozenge composition
FOS 46.07%
(inulin) 46.07%
Glycerin 5%
Cannabis Extract 1.059% (80% potency)
Peppermint oil 0.7%
Lecithin 0.1
128
Date Recue/Date Received 2021-08-20

Residual water 1%
b) Manufacturing process
[00565] The exemplary hold molded lozenge of Example 20 (a) was prepared
following the
method described in Example 13 (b).
[00566] While the present application has been described with reference to
examples, it is to be
understood that the scope of the claims should not be limited by the
embodiments set forth in the
examples, but should be given the broadest interpretation consistent with the
description as a
whole.
[00567] Where a term in the present application is found to be defined
differently in a referenced
document, the definition provided herein is to serve as the definition for the
term.
129
Date Recue/Date Received 2021-08-20