RAPIDLY DISINTERGRATING COMPOSTIONS AND METHODS (Nicotine)

Abstract

A rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and mannitol, and (b) active therapeutic ingredient (ATI). Preferred rapidly infusing compositions are those formulated with nicotine or a derivative/analog thereof as the ATI. A method of administering an ATI such as nicotine or a derivative/analog thereof, to a subject is also disclosed. The subject is administered the rapidly infusing composition via the oral mucosa, for example, to reduce the subject's usage of more harmful nicotine delivery methods and/or nicotine withdrawal symptoms.

1 . A rapidly infused composition, comprising:
 a pharmaceutically acceptable binder and/or excipient system comprising gelatin and mannitol, and   nicotine.   
     
     
         2 . The rapidly infusing composition of  claim 1 , which is lyophilized. 
     
     
         3 . The rapidly infusing composition of  claim 1 , which has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         4 . The rapidly infusing composition of  claim 1 , which has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         5 . The rapidly infusing composition of  claim 1 , wherein the gelatin is present in the rapidly infusing composition in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         6 . The rapidly infusing composition of  claim 1 , wherein the gelatin is mammalian gelatin. 
     
     
         7 . The rapidly infusing composition of  claim 6 , wherein the mammalian gelatin is bovine gelatin. 
     
     
         8 . The rapidly infusing composition of  claim 1 , wherein the mannitol is present in the rapidly infusing composition in an amount of 5 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         9 . The rapidly infusing composition of  claim 1 , wherein the nicotine is present in the rapidly infusing composition in an amount of 0.1 to 25 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         10 . The rapidly infusing composition of  claim 1 , wherein the nicotine is provided in the form of a nicotine salt or a nicotine complex. 
     
     
         11 . The rapidly infusing composition of  claim 10 , wherein the nicotine is provided in the form of the nicotine complex. 
     
     
         12 . The rapidly infusing composition of  claim 11 , wherein the nicotine complex is a nicotine cation exchange resin complex. 
     
     
         13 . The rapidly infusing composition of  claim 12 , wherein the nicotine cation exchange resin complex is nicotine polacrilex. 
     
     
         14 . The rapidly infusing composition of  claim 1 , wherein the nicotine has a purity between 95 and 100% by weight on a basis of nicotine free base. 
     
     
         15 . The rapidly infusing composition of  claim 1 , which is formulated with a solid form of nicotine. 
     
     
         16 . The rapidly infusing composition of  claim 1 , wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant. 
     
     
         17 . The rapidly infusing composition of  claim 16 , wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises a mixture of orange flavor and peppermint flavor. 
     
     
         18 . The rapidly infusing composition of  claim 16 , wherein the rapidly infusing composition comprises the sweetener, and the sweetener comprises a mixture of sucralose and acesulfame-K. 
     
     
         19 . A process for manufacturing the rapidly infusing composition of  claim 1 , comprising:
 dissolving gelatin and mannitol in water to form a solution;   adding the nicotine to the solution to form a drug product suspension; and   lyophilizing the drug product suspension to remove water and form the rapidly infusing composition.   
     
     
         20 . A method of administering nicotine to a subject, comprising administering to the subject in need thereof, via the oral mucosa, a therapeutically effective amount of the rapidly infusing composition of  claim 1 . 
     
     
         21 . The method of  claim 20 , wherein the rapidly infusing composition is administered buccally to the subject via the buccal mucosa. 
     
     
         22 . The method of  claim 20 , wherein the therapeutically effective amount of the rapidly infusing composition is that which provides from 0.1 to 10 mg of nicotine per dose. 
     
     
         23 . The method of  claim 20 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day. 
     
     
         24 . The method of  claim 20 , wherein the subject is a human. 
     
     
         25 . A method of reducing a subject's usage of more harmful nicotine delivery methods, comprising administering to the subject in need thereof, via the oral mucosa, a therapeutically effective amount of the rapidly infusing composition of  claim 1 . 
     
     
         26 . The method of  claim 25 , wherein the rapidly infusing composition is administered buccally to the subject via the buccal mucosa. 
     
     
         27 . The method of  claim 25 , wherein the therapeutically effective amount of the rapidly infusing composition is that which provides from 0.1 to 10 mg of nicotine per dose. 
     
     
         28 . The method of  claim 25 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day. 
     
     
         29 . The method of  claim 25 , wherein the subject is a human. 
     
     
         30 . A method of reducing nicotine withdrawal symptoms in a subject, comprising administering to the subject in need thereof, via the oral mucosa, a therapeutically effective amount of the rapidly infusing composition of  claim 1 . 
     
     
         31 . The method of  claim 30 , wherein the rapidly infusing composition is administered buccally to the subject via the buccal mucosa. 
     
     
         32 . The method of  claim 30 , wherein the therapeutically effective amount of the rapidly infusing composition is that which provides from 0.1 to 10 mg of nicotine per dose. 
     
     
         33 . The method of  claim 30 , wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day. 
     
     
         34 . The method of  claim 30 , wherein the subject is a human.