Disintegrable Oral Films

Abstract

A water soluble film that is disintegrable in the oral cavity to deliver an active agent is provided. The disintegrable film includes at least one water soluble polymer and an active agent. Also provided are methods for preparing the disintegrable oral film and for using the disintegrable film to administer an effective dosage of an active agent into the oral cavity for absorption through the oral mucosa. According to certain embodiments, the disintegrable film includes at least one water soluble polymer and a nicotine active.

1 - 31 . (canceled) 
     
     
         32 . A disintegrable oral film having high mucoadhesivity to the oral mucosa and slow disintegration rate, comprising:
 (a) at least 45 weight percent of at least one water soluble film forming polymer, based on the total weight of the dry film;   (b) an active agent; and optionally   (c) one or more compounds selected from the group consisting of taste-modifying agents, bioadhesive agents, coloring agents, stabilizing agents, inert fillers, emulsifying agents, permeation enhancers, plasticizers, and preservatives;   wherein component (c) is not a pH adjusting agent or buffering agent, and   wherein said oral film maintains at least partial integrity and active agent release capability after in vitro exposure to artificial human saliva solution for at least 15 minutes.   
     
     
         33 . The disintegrable oral film of  claim 32 , wherein said disintegrable oral film comprises from about 45 to about 90 weight percent of said at least one water soluble polymer, based on the total weight of the dry film. 
     
     
         34 . The disintegrable oral film of  claim 32 , wherein said disintegrable oral film comprises a mixture of two different water soluble film forming polymers. 
     
     
         35 . The disintegrable oral film of  claim 34 , wherein said disintegrable oral film comprises a mixture of a polyalkylene oxide and a cellulose polymer. 
     
     
         36 . The disintegrable oral film of  claim 35 , wherein said polyalkylene oxide is polyethylene oxide and said cellulose polymer is hydroxypropyl methylcellulose. 
     
     
         37 . The disintegrable oral film of  claim 36 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is from about 1:2 to about 1:5. 
     
     
         38 . The disintegrable oral film of  claim 37 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:2. 
     
     
         39 . The disintegrable oral film of  claim 37 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:3. 
     
     
         40 . The disintegrable oral film of  claim 37 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:4. 
     
     
         41 . The disintegrable oral film of  claim 37 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:5. 
     
     
         42 . The disintegrable oral film of  claim 32  which additionally comprises a gum. 
     
     
         43 . The disintegrable oral film of  claim 42  which comprises hydroxypropyl methylcellulose and xanthan gum. 
     
     
         44 . The disintegrable oral film of  claim 42  which comprises hydroypropyl methylcellulose and arabic gum. 
     
     
         45 . The disintegrable oral film of  claim 32 , wherein said active agent is a nicotine active. 
     
     
         46 . A disintegrable oral film for delivery of nicotine comprising:
 (a) a mixture of a polyalkylene oxide and a cellulose polymer, wherein the ratio of said polyalkylene oxide to said cellulose polymer present in said film is about 1:2 to about 1:5;   (b) a nicotine active; and optionally   (c) one or more compounds selected from the group consisting of taste-modifying agents, bioadhesive agents, coloring agents, stabilizing agents, inert fillers, emulsifying agents, permeation enhancers, plasticizers, and preservatives;   wherein component (c) is not a pH adjusting agent or buffering agent.   
     
     
         47 . The disintegrable oral film of  claim 46 , wherein said polyalkylene oxide is polyethylene oxide said cellulose polymer is hydroxypropyl methylcellulose. 
     
     
         48 . The disintegrable oral film of  claim 47 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:2. 
     
     
         49 . The disintegrable oral film of  claim 47 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:3. 
     
     
         50 . The disintegrable oral film of  claim 47 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:4. 
     
     
         51 . The disintegrable oral film of  claim 47 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:5. 
     
     
         52 . The disintegrable oral film of  claim 46  wherein said film maintains at least partial integrity and active agent release capability after in vitro exposure to artificial human saliva solution for at least 15 minutes. 
     
     
         53 . A dry oral film having high mucoadhesivity to the oral mucosa and slow disintegration rate, comprising:
 (a) at least 45 weight percent of at least one water soluble film forming polymer, based on the total weight of the dry film; and   (b) an active agent;   wherein said dry oral film maintains at least partial integrity and active agent release capability after in vitro exposure to artificial human saliva solution for at least 15 minutes, and   wherein said dry oral film does not contain a buffer or pH adjusting agent.   
     
     
         54 . A method of administering an active agent comprising:
 providing a dry oral film of  claim 53 ; and   introducing said dry oral film into the oral cavity.