Compositions and methods for sublingual delivery of nicotine

Abstract

Disclosed herein are compositions and methods for oral delivery of nicotine and nicotine derivatives. In one embodiment the nicotine is delivered in an oral packets, pouches, or sachets.

What is claimed is: 
     
         1 . A composition comprising:
 a) from about 0.25% to about 6% by weight of nicotine, a nicotine salt, nicotine in combination with a resin, or mixtures thereof;   b) from about 1% to about 20% by weight of an edible oil;   c) from about 5% to about 20% by weight of sodium bicarbonate; and   d) the balance one or more carriers.   
     
     
         2 . The composition according to  claim 1 , comprising nicotine. 
     
     
         3 . The composition according to  claim 1 , comprising a nicotine salt. 
     
     
         4 . The composition according to  claim 3 , wherein the nicotine salt is chosen from, and polymer resins of containing nicotine. Non-limiting examples of nicotine salts includes nicotine benzoate, nicotine lactate, nicotine malate, nicotine ditartrate, nicotine salicylate, nicotine citrate and nicotine levulinate. 
     
     
         5 . The composition according to  claim 1 , comprising nicotine in combination with a resin. 
     
     
         6 . The composition according to  claim 5 , wherein the nicotine in combination with a resin is nicotine polacrilex or nicotine resinate. 
     
     
         7 . The composition according to  claim 1 , wherein the edible oil is chosen from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, or peanut oil. 
     
     
         8 . The composition according to  claim 1 , wherein the carrier is chosen from inulin, microcrystalline cellulose, galactogen, cellulose, chitin, pectin, psyllium, guar, hemicellulose, potato starch, or partially hydrolyzed polysaccharides 
     
     
         9 . The composition according to  claim 1 , wherein the carrier is chosen from sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, or isomaltose. 
     
     
         10 . The composition according to  claim 1 , further comprising glycerol, propylene glycol, (3-cyclodextrin, propylene glycol 400 (PEG 400), or mixtures thereof. 
     
     
         11 . The composition according to  claim 1 , wherein the ratio of nicotine, a nicotine salt, nicotine in combination with a resin to the edible oil is from about 1:1 to about 1:4. 
     
     
         12 . A composition, comprising:
 a) from about 0.5 mg to about 50 mg by weight of nicotine, a nicotine salt, nicotine in combination with a resin, or mixtures thereof;   b) from about 10 mg to about 160 mg by weight of an edible oil; and   c) from about 25 mg to about 300 mg by weight of sodium bicarbonate.   
     
     
         13 . The composition according to  claim 12 , comprising from 15 mg to about 40 mg by weight of nicotine, a nicotine salt, nicotine in combination with a resin, or mixtures thereof. 
     
     
         14 . The composition according to  claim 12 , further comprising a carrier chosen from inulin, microcrystalline cellulose, galactogen, cellulose, chitin, pectin, psyllium, guar, hemicellulose, potato starch, partially hydrolyzed polysaccharides, from sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, or isomaltose. 
     
     
         15 . The composition according to  claim 12 , further comprising glycerol, propylene glycol, (3-cyclodextrin, propylene glycol 400 (PEG 400), or mixtures thereof. 
     
     
         16 . The composition according to  claim 12 , comprising:
 a) from about 8.6 mg to about 21.7 mg of nicotine, a nicotine salt, nicotine in combination with a resin, or mixtures thereof;   b) from about 25.8 to about 72.6 mg of sunflower oil; and   c) from about 76.1 mg to about 86.6 mg of sodium bicarbonate.   
     
     
         17 . A kit, comprising:
 A) a liquid permeable pouch comprising a non-nicotine composition comprising:
 a) one or more delivery control agents; and 
 b) a bulking agent; and 
   B) a base nicotine delivery composition comprising:
 a) nicotine, a nicotine salt, nicotine in combination with a resin, or mixtures thereof; 
 b) sunflower oil; 
 c) sodium bicarbonate; and 
 d) the balance one or more carriers. 
   
     
     
         18 . The kit according to  claim 17 , wherein the liquid permeable pouch comprises wheat fibers, oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fiber, powdered cellulose, bamboo fibers, bran fibers or combinations thereof. 
     
     
         19 . The kit according to  claim 17 , comprising:
 B) from about 70 mg to about 510 mg of an active base delivery system, comprising:
 a) from about 5 mg to about 50 mg by weight of nicotine benzoate; 
 b) from about 15 mg to about 160 mg by weight of sunflower oil; 
 c) from about 50 mg to about 300 mg by weight of sodium bicarbonate; 
 d) from about 350 mg to about 1500 mg of one or more carriers; and 
 e) the balance one or more delivery control agents 
   
     
     
         20 . The kit according to  claim 17 , wherein the carrier is chosen from inulin, microcrystalline cellulose, galactogen, cellulose, chitin, pectin, psyllium, guar, hemicellulose, potato starch, or partially hydrolyzed polysaccharides, sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, or isomaltose.