Oral composition comprising encapsulated ph adjusting agent

Abstract

The disclosure provides a composition configured for oral use, the composition including at least one filler; a nicotine component; and an encapsulated pH adjusting agent. The composition is typically formulated to have an initial pH in the acidic range to reduce initial throat burn associated with the product.

What is claimed is: 
     
         1 . A composition configured for oral use, the composition comprising:
 at least one filler;   a nicotine component; and   an encapsulated pH adjusting agent.   
     
     
         2 . The composition of  claim 1 , wherein the encapsulated pH adjusting agent is selected from the group consisting of an alkali metal hydroxide, alkali metal carbonate, alkali metal bicarbonate, alkali metal acetate, alkali metal glycinate, alkali metal phosphate, alkali metal gluconate, alkali metal glycerophosphate, alkali metal citrate, alkali metal glutamate, alkali metal borate, alkali metal lactate, and mixtures thereof. 
     
     
         3 . The composition of  claim 1 , wherein the encapsulated pH adjusting agent is an alkali metal carbonate, alkali metal bicarbonate, or a mixture thereof. 
     
     
         4 . The composition of  claim 1 , wherein the encapsulated pH adjusting agent has a pKa greater than 7. 
     
     
         5 . The composition of  claim 4 , wherein the encapsulated pH adjusting agent has a pKa of about 8 to about 11. 
     
     
         6 . The composition of  claim 1 , wherein an initial pH of the composition is below about 5. 
     
     
         7 . The composition of  claim 1 , wherein an initial pH of the composition is between about 4 and about 5. 
     
     
         8 . The composition of  claim 1 , wherein a water content of the composition is about 20% by weight or less. 
     
     
         9 . The composition of  claim 8 , wherein the water content of the composition is about 15% by weight or less. 
     
     
         10 . The composition of  claim 1 , wherein the encapsulated pH adjusting agent comprises an encapsulant selected from the group consisting of gelatin, acacia (gum arabic), polyvinyl acetate, potassium alginate, carob bean gum, potassium citrate, carrageenan, potassium polymetaphosphate, citric acid, potassium tripolyphosphate, dextrin, polyvinyl alcohol, povidone, dimethylpolysiloxane, mannitol, dimethyl silicone, refined paraffin wax, ethylcellulose, bleached shellac, modified food starch, sodium alginate, guar gum, sodium carboxymethylcellulose, hydroxypropyl cellulose, sodium citrate, hydroxypropylmethylcellulose, sodium ferrocyanide, sodium polyphosphates, locust bean gum, methylcellulose, sodium trimetaphosphate, methyl ethyl cellulose, sodium tripolyphosphate, microcrystalline wax, tannic acid, petroleum wax, terpene resin, tragacanth, polyethylene, xanthan gum, and polyethylene glycol. 
     
     
         11 . The composition of  claim 1 , wherein the encapsulated pH adjusting agent comprises an encapsulant selected from maltodextrin, gum arabic, and hydroxypropylmethylcellulose. 
     
     
         12 . The composition of  claim 1 , wherein the nicotine component is present in an amount of from about 0.001 to about 10% by weight of the composition, calculated as the free base and based on the total weight of the composition. 
     
     
         13 . The composition of  claim 1 , wherein the nicotine component is selected from nicotine free base, a nicotine salt, a nicotine-polymer complex, or combinations thereof. 
     
     
         14 . The composition of any one of  claim 1 , wherein the at least one filler comprises a cellulose material. 
     
     
         15 . The composition of  claim 14 , wherein the cellulose material comprises microcrystalline cellulose. 
     
     
         16 . The composition of  claim 1 , further comprising an additional active ingredient selected from the group consisting of botanical materials, stimulants, amino acids, vitamins, antioxidants, nutraceuticals, cannabinoids, cannabimimetics, terpenes, pharmaceutical agents, and combinations thereof. 
     
     
         17 . The composition of  claim 1 , further comprising one or more flavoring agents, one or more salts, one or more sweeteners, one or more binding agents, one or more humectants, one or more gums, a tobacco material, or combinations thereof. 
     
     
         18 . The composition of  claim 1 , wherein the composition is substantially free of tobacco material. 
     
     
         19 . The composition of  claim 1 , comprising:
 the filler in an amount of at least 50% by weight;   the nicotine component in an amount of about 0.1 to about 10% by weight; and   the encapsulated pH adjusting agent in an amount of about 0.1 to about 5% by weight, all based on the total weight of the composition.   
     
     
         20 . The composition of  claim 19 , further comprising one or more of:
 sodium chloride in an amount of about 0.1 to about 10% by weight;   a sugar alcohol in an amount of about 0.1 to about 5% by weight;   a sweetener in an amount of about 0.1 to about 5% by weight; and   a humectant in an amount of about 0.1 to about 5% by weight, all based on the total weight of the composition.   
     
     
         21 . The composition of  claim 1 , enclosed in a pouch to form a pouched product. 
     
     
         22 . The composition of  claim 1 , in the form of a gel, pastille, gum, chew, melt, tablet, lozenge, granular material, or powder. 
     
     
         23 . A method for preparing a composition configured for oral use, the method comprising:
 mixing at least one filler with at least one additional powder component to form a dry powder mixture;   mixing water with one or more water-miscible or water-soluble components to form an aqueous solution, wherein at least one of the dry powder mixture and the aqueous solution comprise a nicotine component;   adding the aqueous solution to the dry powder mixture to form a wet powder mixture comprising the nicotine component;   adjusting the pH of the wet powder mixture into an acidic pH range; and   adding an encapsulated pH adjusting agent to the wet powder mixture to form the composition configured for oral use.