CHEWING GUM COMPOSITION COMPRISING CANNABINOIDS AND GABAPENTIN
A chewing gum composition comprising cannabinoids or derivatives thereof and gabapentin is provided. The chewing gum composition is formulated to provide controlled release of cannabinoids and gabapentin during mastication. Methods to provide post-herpetic neuralgia and restless leg syndrome treatment using the chewing gum composition according to this invention are also provided.
1 . A chewing gum composition comprising, based on total weight of the composition:
0.125 to 7.5% by weight of at least one cannabinoid;
5 to 15% by weight of gabapentin;
20 to 80% by weight of a gum base;
5 to 35% by weight of at least one buffering agent selected from the group consisting of acetates, glycinates, phosphates, carbonates, glycerophosphates, citrates, and borates;
1 to 10% by weight of at least one flavoring agent;
1 to 65% by weight of at least one sweetening agent selected from the group consisting of isomalt, sorbitol, stevia, maltitol, mannitol, and xylitol; and
at least one anti-oxidant selected from the group consisting of ascorbyl palminate and sodium ascorbate.
2 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is cannabidiol, cannabichromene, cannabigerol, cannabidivarin, derivatives thereof, or their acid metabolites.
3 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is Δ 9 -tetrahydrocannabinol.
4 . The chewing gum composition of claim 3 , wherein Δ 9 -tetrahydrocannabinol is present at 0.125 to 1% by weight of the total composition.
5 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is present in combination with at least one suitable carrier selected from the group consisting of sugar alcohol, microcrystalline cellulose derivatives, dextran, agarose, agar, pectin, alginate, xanthan, chitosan, and starch.
6 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is present in freeze dried form.
7 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is present in internal voids within a suitable solid carrier.
8 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is present in combination with a carrier in a granule within the gum matrix.
9 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid is procured from natural sources or synthetic.
10 . The chewing gum composition of claim 1 , wherein the at least one flavoring agent is selected from the group consisting of peppermint, spearmint, cinnamon, licorice, cherry, orange, peach, and watermelon.
11 . The chewing gum composition of claim 1 , wherein the at least one cannabinoid and the gabapentin are provided as microencapsulated or nanoencapsulated particles.
12 . The chewing gum composition of claim 11 , wherein the nanoencapsulated or microencapsulated gabapentin or cannabinoid particles are liposomal particles.
13 . The chewing gum composition of claim 1 , further comprising at least one preservative and at least one antioxidant.
14 . The chewing gum composition of claim 13 , wherein the preservative is citric acid.
15 . The chewing gum composition of claim 13 , further comprising at least one pharmaceutically acceptable excipient selected from the group consisting of fillers, disintegrants, binders, and lubricants.
16 . The chewing gum composition of claim 15 , further comprising silicon dioxide or magnesium stearate.
17 . A method to treat post-herpetic neuralgia in a mammal in need thereof, comprising administering to the mammal a chewing gum composition of claim 1 .
18 . The method of claim 17 , wherein the mammal receives the chewing gum administration 1 to 6 times a day.
19 . A method to treat restless leg syndrome in a mammal in need thereof, comprising administering to the mammal a chewing gum composition of claim 1 .
20 . The method of claim 19 , wherein the mammal receives the chewing gum administration 1 to 6 times a day.