Solid dosage form composition for buccal or sublingual administration of cannabinoids

Abstract

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.

What is claimed is: 
     
         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.