SOLID DOSAGE FORM COMPOSITION FOR BUCCAL OR SUBLINGUAL ADMINISTRATION OF CANNABINOIDS
The present invention relates to solid dosage forms of cannabinoid pharmaceutical formulations comprising a solvated cannabinoid for buccal or sublingual administration, and methods of making and using the same.
1 . A pharmaceutical composition in a solid dosage form for sublingual or buccal administration, comprising:
a cannabinoid;
a pharmaceutically-acceptable solvent into which the cannabinoid is solvated; and
a pharmaceutically-acceptable adsorbent onto which the solvated cannabinoid is adsorbed.
2 . The composition of claim 1 , wherein the solvent comprises polyethylene glycol, ethanol, substituted polyethylene glycols, propylene glycol, propylene carbonate, or a mixture thereof.
3 . The composition of claim 2 , wherein the solvent comprises ethanol.
4 . The composition of claim 1 , wherein the adsorbent comprises silica, microcrystalline cellulose, cellulose, silicified microcrystalline cellulose, clay, talc, starch, pregelatinized starch, calcium carbonate, dicalcium phosphate, magnesium carbonate, and mixtures thereof.
5 . The composition of claim 4 , wherein the pharmaceutically acceptable adsorbent comprises silica.
6 . The pharmaceutical composition of claim 5 , wherein the silica is silicon dioxide, amorphous silica, hydrated silicon dioxide, fumed silica, colloidal silicon dioxide, magnesium aluminum silicate, magnesium silicate, calcium silicate, or a mixture thereof.
7 . The composition of claim 1 , wherein the cannabinoid comprises delta-9-tetrahydrocannabinol (THC).
8 . The composition of claim 7 , wherein the THC is present at from about 0.5 mg to about 50 mg.
9 . The composition of claim 7 , wherein the THC is present at from about 10 mg to about 30 mg.
10 . The composition of claim 1 , wherein the cannabinoid comprises cannabidiol (CBD).
11 . The composition of claim 10 , wherein the CBD is present at from about 0.5 mg to about 50 mg.
12 . The composition of claim 11 , wherein the CBD is present at from about 10 mg to about 30 mg.
13 . The composition of claim 4 , wherein the weight/weight ratio of silica:cannabinoid solution is from about 1:0.5 to about 1:5.
14 . The composition of claim 1 , further comprising a water-soluble diluent, a disintegrant, a lubricant, or mixtures thereof.
15 . The composition of claim 14 , wherein the water-soluble diluent comprises mannitol.
16 . The method of claim 14 , wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.
17 . The method of claim 14 , wherein the lubricant comprises sodium stearyl fumarate.
18 . The pharmaceutical composition of claim 1 , which is in the form of a tablet or film.
19 . A method for preparing a pharmaceutical composition comprising a solvated cannabinoid in a solid dosage form for sublingual or buccal administration having increased oral bioavailability and shortened onset of action of the cannabinoid, the method comprising:
solvating the cannabinoid in a pharmaceutically acceptable solvent to form a solvated cannabinoid;
mixing the solvated cannabinoid with an adsorbent, onto which the solvated cannabinoid is adsorbed; and
processing the solvated cannabinoid/adsorbent into a solid dosage form.
20 . The method of claim 19 , wherein the cannabinoid comprises THC or CBD.
21 . The method of claim 19 , wherein the adsorbent comprises silica.
22 . The method of claim 19 , wherein the solvent comprises ethanol.
23 . The method of claim 19 , wherein the excipient added is a lubricant, a water-soluble diluent, a disintegrant, or a mixture thereof.
24 . The method of claim 23 , wherein the lubricant comprises sodium stearyl fumarate.
25 . The method of claim 23 , wherein the water-soluble diluent comprises mannitol.
26 . The method of claim 23 , wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.
27 . The method of claim 23 , further comprising processing the solvated cannabinoid/adsorbent composition into a tablet.
28 . A pill pack comprising the cannabinoid composition of claim 1 encased within a packaging enclosure.