Compositions and products for improved oral delivery of nicotine and methods of making and using same

Abstract

The present disclosure provides improved compositions for wet nicotine pouches with improved stability and user experiences, along with methods of their production and use.

What is claimed is: 
     
         1 . A moistened nicotine powder composite comprising
 a. an encapsulated hydrophobic nicotine powder mixture comprising
 i. an encapsulated nicotine powder comprising supercritical CO2 processed nicotine complexed with at least one polymer and at least one cyclodextrin, and 
 ii. a bulking agent, and 
   b. a water-entrapped powder complex comprising
 i. a water-absorbing powder blend comprising microcrystalline cellulose, a gelling agent, and an anti-caking agent, and 
 ii. an aqueous solution comprising water, a water soluble sweetener, and a pH adjuster. 
   
     
     
         2 . The moistened nicotine powder composite of  claim 1 , wherein the encapsulated hydrophobic nicotine powder mixture further comprises at least one flavoring agent. 
     
     
         3 . The moistened nicotine powder composite of  claim 1 , wherein the encapsulated nicotine powder further comprises a lipophilic sweetener. 
     
     
         4 . The moistened nicotine powder composite of  claim 1 , wherein the aqueous solution further comprises at least one humectant. 
     
     
         5 . The moistened nicotine powder composite of  claim 1 , wherein the aqueous solution further comprises at least one flavoring agent. 
     
     
         6 . The moistened nicotine powder composite of  claim 1 , wherein moisture content is from about 5% to about 65%. 
     
     
         7 . The moistened nicotine powder composite of  claim 1 , wherein the stability of the nicotine content is 70% or greater after being subjected to accelerated storage conditions of 40° C. and 75% relative humidity for 1 week, 2 weeks, 3 weeks, or 4 weeks. 
     
     
         8 . The moistened nicotine powder composite of  claim 1 , further comprising a pouch, wherein the pouch is permeable for saliva. 
     
     
         9 . A method of administering the pouch of  claim 8  to a subject, the method comprising contacting the pouch with the subject's mouth. 
     
     
         10 . A method of making a moistened nicotine powder composite, said method comprising
 a. preparing an encapsulated nicotine powder mixture by encapsulating nicotine with at least one polymer and at least one cyclodextrin under supercritical CO2 conditions,   b. preparing an encapsulated hydrophobic nicotine powder mixture by mixing the encapsulated nicotine powder mixture with a bulking agent,   c. preparing a water-absorbing powder blend by blending microcrystalline cellulose, a gelling agent, and an anti-caking agent,   d. preparing an aqueous solution by dissolving a sweetener and a pH adjuster in water,   e. preparing a water-entrapped powder complex by mixing the water-absorbing powder blend with the aqueous solution, and   f. preparing the moistened nicotine powder composite by mixing the encapsulated hydrophobic nicotine powder mixture with the water-entrapped powder complex.   
     
     
         11 . The method of  claim 10 , wherein the at least one cyclodextrin is α-cyclodextrin and/or β-cyclodextrin. 
     
     
         12 . The method of  claim 10 , wherein the at least one polymer is a poloxamer. 
     
     
         13 . The method of  claim 10 , wherein the bulking agent is microcrystalline cellulose (MCC). 
     
     
         14 . The method of  claim 10 , wherein the encapsulated hydrophobic nicotine powder mixture further comprises at least one flavoring agent. 
     
     
         15 . The method of  claim 10 , wherein the encapsulated nicotine powder further comprises a lipophilic sweetener. 
     
     
         16 . The method of  claim 10 , wherein the aqueous solution further comprises at least one humectant. 
     
     
         17 . The method of  claim 10 , wherein the aqueous solution further comprises at least one flavoring agent. 
     
     
         18 . The method of  claim 10 , wherein moisture content of the moistened nicotine powder composite is from about 5% to about 65%. 
     
     
         19 . The method of  claim 10 , further comprising adding the moistened nicotine powder composite to a pouch, wherein the pouch is permeable for saliva. 
     
     
         20 . The method of  claim 19 , wherein additional water is added to the pouch.