Orally disintegrating, sublingual and buccal formulations

Abstract

The present invention is related to an orally disintegrating, sublingual or buccal formulation of active ingredient such as cannabidiol or tetrahydrocannabinol.

1 . An oral dosage form, wherein the oral dosage form is orally disintegrating, buccal or sublingual, comprising:
 (a) about 0.5 to 3% wt/wt of a sweetener selected from the group consisting of mannitol, sorbitol, xylitol, lactitol, erythritol, and a combination thereof;   (b) about 6.5 to 20% wt/wt citric acid, oleic acid, caprylic acid, tartaric acid, or succinic acid;   (c) about 6.5 to 20% wt/wt sodium bicarbonate, potassium bicarbonate, or potassium carbonate;   (d) about 1 to 5% wt/wt sodium carbonate or calcium carbonate;   (e) about 25 to 35% wt/wt silicon dioxide or calcium phosphate;   (f) about 5 to 10% wt/wt cellulose, lecithin, corn starch, potato starch, pectin, or agar;   (g) about 25 to 35% wt/wt dibasic calcium phosphate anhydrous;   (h) about 0.5 to 1% wt/wt menthol extract;   (i) about 2.5 to 7% wt/wt potassium hydrogen tartrate; and,   (j) about 0.5 to 1.5% wt/wt active ingredient selected from the group consisting of tetrahydrocannabinol (THC) extract, cannabidiol (CBD) extract, an analog of the foregoing, a derivative of the foregoing, and a combination thereof.   
     
     
         2 . The oral dosage form of  claim 1 , wherein the sweetener is mannitol. 
     
     
         3 . The oral dosage form of  claim 1 , comprising citric acid. 
     
     
         4 . The oral dosage form of  claim 1 , comprising sodium bicarbonate. 
     
     
         5 . The oral dosage form of  claim 1 , comprising sodium carbonate. 
     
     
         6 . The oral dosage form of  claim 1 , comprising silicon dioxide. 
     
     
         7 . The oral dosage form of  claim 1 , comprising cellulose. 
     
     
         8 . The oral dosage form of  claim 1 , wherein the menthol extract is menthol oil (0.3 mg). 
     
     
         9 . The oral dosage form of  claim 1 , wherein the active ingredient comprises an ingredient selected from the group consisting of THC extract, CBD extract, tetrahydrocannabinolic acid (THCa) extract, and cannabidiolic acid (CBDa) extract. 
     
     
         10 . The oral dosage form of  claim 9 , wherein the active ingredients comprises THC extract. 
     
     
         11 . The oral dosage form of  claim 1 , comprising:
 (a) about 3% wt/wt mannitol;   (b) about 15% wt/wt citric acid;   (c) about 15% wt/wt sodium bicarbonate;   (d) about 5% wt/wt sodium carbonate;   (e) about 25% wt/wt silicon dioxide;   (f) about 5% wt/wt cellulose;   (g) about 25% wt/wt dibasic calcium phosphate anhydrous;   (h) about 0.75% wt/wt menthol oil (0.3 mg);   (i) about 5% wt/wt potassium hydrogen tartrate; and,   (j) about 1.25% wt/wt THC extract.   
     
     
         12 . The oral dosage form of  claim 1 , wherein the oral dosage form is a solid tablet or powder. 
     
     
         13 . The oral dosage form of  claim 12 , wherein the oral dosage form is a solid tablet. 
     
     
         14 . The oral dosage form of  claim 1 , wherein the oral dosage form is effervescent when dissolved in an aqueous solution. 
     
     
         15 . An orally disintegrating, sublingual or buccal dosage form, consisting of:
 (a) 3% wt/wt mannitol;   (b) 15% wt/wt citric acid;   (c) 15% wt/wt sodium bicarbonate;   (d) 5% wt/wt sodium carbonate;   (e) 25% wt/wt silicon dioxide;   (f) 5% wt/wt cellulose;   (g) 25% wt/wt dibasic calcium phosphate anhydrous;   (h) 0.75% wt/wt menthol extract;   (i) 5% wt/wt potassium hydrogen tartrate; and,   (j) 1.25% wt/wt THC extract.   
     
     
         16 . The dosage form of  claim 15 , wherein the menthol extract is menthol oil (0.3 mg). 
     
     
         17 . The dosage form of  claim 15 , wherein the dosage form is a solid tablet. 
     
     
         18 . The dosage form of any one of  claim 15 , wherein the dosage form is effervescent when dissolved in an aqueous solution.