US2007202057A1PendingUtilityA1

Disintegrable oral films

63
Individually held — no corporate assignee on recordPriority: Feb 17, 2006Filed: Feb 16, 2007Published: Aug 30, 2007
Est. expiryFeb 17, 2026(expired)· nominal 20-yr term from priority
Inventors:Christopher Edward FankhauserGreg SlominskiStephan Meyer
A61K 9/7007A61P 25/34A61K 9/006A61K 47/36A61K 47/10A61K 47/38A61K 9/0056A61K 31/465
63
PatentIndex Score
0
Cited by
0
References
0
Claims

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.

Claims

exact text as granted — not AI-modified
1 . A disintegrable oral film having high mucoadhesivity to the oral mucosa and slow disintegration rate, comprising: 
 at least 45 weight percent of at least one water soluble film forming polymer, based on the total weight of the dry film; and    an active agent,    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.    
   
   
       2 . The disintegrable oral film of  claim 1 , 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.  
   
   
       3 . The disintegrable oral film of  claim 1 , wherein said disintegrable oral film comprises a mixture of two different water soluble film forming polymers.  
   
   
       4 . The disintegrable oral film of  claim 3 , wherein said disintegrable oral film comprises a mixture of a polyalkylene oxide and a cellulose polymer.  
   
   
       5 . The disintegrable oral film of  claim 4 , wherein said polyalkylene oxide is polyethylene oxide and said cellulose polymer is hydroxypropyl methylcellulose.  
   
   
       6 . The disintegrable oral film of  claim 5 , wherein the ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is from about 1:2 to about 1:5 (wt/wt).  
   
   
       7 . The disintegrable oral film of  claim 6 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:2.  
   
   
       8 . The disintegrable oral film of  claim 6 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:3.  
   
   
       9 . The disintegrable oral film of  claim 6 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:4.  
   
   
       10 . The disintegrable oral film of  claim 6 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:5.  
   
   
       11 . The disintegrable oral film of  claim 1  which additionally comprises a gum.  
   
   
       12 . The disintegrable oral film of  claim 2  which comprises hydroxypropyl methylcellulose and xanthan gum.  
   
   
       13 . The disintegrable oral film of  claim 2  which comprises hydroypropyl methylcellulose and arabic gum.  
   
   
       14 . The disintegrable oral film of  claim 5 , wherein said active agent is a nicotine active.  
   
   
       15 . The disintegrable oral film of  claim 11 , wherein said nicotine active comprises free nicotine base, nicotine derivatives, nicotine complexes, nicotine salts, or mixtures thereof.  
   
   
       16 . The disintegrable oral film of  claim 12 , wherein said nicotine active is nicotine bitartrate.  
   
   
       17 . A disintegrable oral film for delivery of nicotine comprising: 
 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 (wt/wt); and    a nicotine active.    
   
   
       18 . The disintegrable oral film of  claim 17 , wherein said polyalkylene oxide is polyethylene oxide said cellulose polymer is hydroxypropyl methylcellulose.  
   
   
       19 . The disintegrable oral film of  claim 18 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:2.  
   
   
       20 . The disintegrable oral film of  claim 18 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:3.  
   
   
       21 . The disintegrable oral film of  claim 18 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:4.  
   
   
       22 . The disintegrable oral film of  claim 18 , wherein said ratio of polyethylene oxide to hydroxypropyl methylcellulose in the film is about 1:5.  
   
   
       23 . The disintegrable oral film of  claim 17 , wherein said nicotine active comprises free nicotine base, nicotine derivatives, nicotine complexes, nicotine salts, or mixtures thereof.  
   
   
       24 . The disintegrable oral film of  claim 23 , wherein said nicotine active is nicotine bitartrate.  
   
   
       25 . The disintegrable oral film of  claim 17  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.  
   
   
       26 . A disintegrable oral film for delivery of nicotine comprising: 
 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; and    nicotine bitartrate,    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.    
   
   
       27 . A method for preparing a disintegrable oral film comprising: 
 mixing together at least one water soluble film forming polymer, and an active agent to form a mixture; and    forming a film from the mixture, wherein said film comprises at least 45 weight percent of said water soluble polymer based on the total weight of the dry film.    
   
   
       28 . A method for preparing a disintegrable oral film comprising: 
 mixing together at least one polyalkylene oxide polymer, at least one cellulose polymer, and an active agent to form a mixture, wherein the ratio of said polyalkylene oxide polymer to said cellulose polymer present in said film is about 1:2 to about 1:5 (wt/wt); and    forming a film from the mixture.    
   
   
       29 . A method of administering an active agent comprising: 
 providing a disintegrable oral film comprising least 45 weight percent of at least one water soluble film forming polymer, based on the total weight of the dry film, and an active agent; and    introducing said film into the oral cavity.    
   
   
       30 . A method of administering an active agent comprising: 
 providing a disintegrable film comprising 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 (wt/wt) and an active agent; and    introducing said film into the oral cavity.    
   
   
       31 . A method of administering an active agent comprising: 
 providing a disintegrable oral film comprising at least one water soluble film forming polymer, 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; and    introducing said film into the oral cavity.

Join the waitlist — get patent alerts

Track US2007202057A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.