Nicotine-containing pharmaceutical composition

Abstract

A composition intended to be employed for therapeutic purposes incorporates a nicotinic compound, a sugar substitute, and a sugar alcohol syrup. Representative forms of nicotine include free base (e.g., as a mixture of nicotine and microcrystalline cellulose), a nicotine salt (e.g., as nicotine bitartrate) or nicotine polacrilex. The composition is useful for treatment of central nervous system conditions, diseases, and disorders, and as a nicotine replacement therapy.

1 . A nicotine-containing pharmaceutical composition, comprising:
 a. a nicotinic compound;   b. a sugar substitute in an amount of at least about 80% by weight; and   c. a sugar alcohol syrup,   wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix and wherein the composition is in a pharmaceutically acceptable form adapted for oral delivery of the composition.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein at least a portion of the nicotinic compound is in the form of a free base, a salt, a complex, or a solvate. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein the nicotinic compound is nicotine polacrilex. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the nicotinic compound is sorbed onto a porous particulate carrier. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the porous particulate carrier comprises microcrystalline cellulose. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the sugar substitute is isomalt. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the sugar alcohol syrup is in an amount sufficient to slow recrystallization of the sugar substitute in melted form. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the sugar alcohol syrup is maltitol syrup or xylitol syrup. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the composition comprises at least about 85% by weight of the sugar substitute. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the composition comprises at least about 4.0% by weight of sugar alcohol syrup. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the composition comprises at least about 4.5% by weight of sugar alcohol syrup. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the composition is in the form of a lozenge or tablet. 
     
     
         13 . The pharmaceutical composition of  claim 1 , wherein the composition is translucent. 
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein the composition further comprises one or more flavorants. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the amount of flavorant is from about 0.1 to about 0.5 percent by weight of the pharmaceutical composition. 
     
     
         16 . The pharmaceutical composition of  claim 14 , wherein the flavorant is vanillin and/or mint flavor. 
     
     
         17 . The pharmaceutical composition of  claim 1 , further comprising at least one sweetener. 
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the at least one sweetener comprises sucralose. 
     
     
         19 . The pharmaceutical composition of  claim 1 , further comprising NaCl. 
     
     
         20 . The pharmaceutical composition of  claim 19 , wherein the amount of NaCl is from about 0.5 to about 1 percent by weight of the pharmaceutical composition. 
     
     
         21 .- 47 . (canceled)