Oral Formulations of Kava

Abstract

Disclosed herein are oral formulations comprising a nicotine composition and a kava composition. Also disclosed herein are oral formulation comprising a kava composition and optionally, a kratom composition. The foregoing oral formulations may be formulated as a chewable tablet, a lozenge, a chewing gum, a dissolvable oral strip, or a pouch. Disclosed herein are methods for making the foregoing oral formulations and using the same. Further disclosed herein are oral formulations comprising a tobacco leaf composition and a kava composition, as well as methods of making and using the same.

1 . An oral formulation comprising:
 an amount of a nicotine composition; and   an amount of a kava composition;
 wherein the kava composition comprises at least one kavalactone selected from the group consisting of kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin. 
   
     
     
         2 . The oral formulation of  claim 1 , wherein the nicotine composition comprises one or more compounds selected from the group consisting of nicotine, nicotine acetate, nicotine benzoate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine citrate, nicotine dihydrochloride, nicotine formate, nicotine hydrochloride, nicotine lactate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine polacrilex, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine sulphate, nicotine tartrate, nicotine zinc chloride monohydrate, and any combination thereof. 
     
     
         3 . The oral formulation of  claim 2 , wherein the nicotine composition comprises nicotine bitartrate dihydrate. 
     
     
         4 . The oral formulation of  claim 3 , wherein the nicotine composition comprises between about 0.1 mg and about 20 mg of nicotine bitartrate dihydrate. 
     
     
         5 . The oral formulation of  claim 1 , wherein the kava composition comprises between about 100 mg and about 600 mg of total kavalactones. 
     
     
         6 . The oral formulation of  claim 5 , wherein the kava composition comprises between about 225 mg and about 300 mg of total kavalactones. 
     
     
         7 . The oral formulation of  claim 1 , wherein the oral formulation is formulated as a chewable tablet, a lozenge, a chewing gum, a dissolvable oral strip, or a pouch. 
     
     
         8 . An oral nicotine-free formulation comprising:
 an amount of a kratom composition; and   an amount of a kava composition;
 wherein the kratom composition comprises at least one kratom alkaloid selected from the group consisting of mitragynine, paynantheine, speciociliatine, and speciogynine; 
 wherein the kava composition comprises at least one kavalactone selected from the group consisting of kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin; and 
 wherein the oral nicotine-free formulation is formulated as a chewable tablet, a lozenge, a chewing gum, a dissolvable oral strip, or a pouch. 
   
     
     
         9 . The oral nicotine-free formulation of  claim 8 , wherein the kava composition comprises between about 100 mg and about 600 mg of total kavalactones. 
     
     
         10 . The oral nicotine-free formulation of  claim 9 , wherein the kava composition comprises between about 225 mg and about 300 mg of total kavalactones. 
     
     
         11 . The oral nicotine-free formulation of  claim 10 , wherein the kava composition is formulated as a paste. 
     
     
         12 . An oral tobacco formulation comprising:
 an amount of a tobacco leaf composition; and   an amount of a kava composition;
 wherein the kava composition comprises at least one kavalactone selected from the group consisting of kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin. 
   
     
     
         13 . The oral tobacco formulation of  claim 12 , wherein the kava composition comprises between about 100 mg and about 600 mg of total kavalactones. 
     
     
         14 . The oral tobacco formulation of  claim 13 , wherein the kava composition comprises between about 225 mg and about 300 mg of total kavalactones. 
     
     
         15 . The oral tobacco formulation of  claim 14 , wherein the kava composition is formulated as a paste.