Methods of producing a terminally sterilized topical patch preparation

Abstract

Methods of producing a terminally sterilized topical patch preparation are provided. In the subject methods, a topical patch preparation is exposed to electron beam radiation, preferably low level electron beam radiation, for a period of time sufficient to terminally sterilize the topical patch preparation. Also provided are the terminally sterilized topical patch preparations produced by the subject methods and methods of using the same.

What is claimed is:  
     
         1 . A method of producing a terminally sterilized topical patch preparation, said method comprising: 
 exposing a topical patch preparation to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation;    whereby a terminally sterilized topical patch preparation is produced.    
     
     
         2 . The method of  claim 1 , wherein said topical patch preparation is sealed in a packaging material containing an aluminum layer.  
     
     
         3 . The method of  claim 2 , wherein said sealed topical patch preparation is produced by: 
 (a) providing a topical patch preparation;    (b) packaging said topical patch preparation in packaging material comprising an aluminum layer; and    (c) sealing said packaged topical patch preparation.    
     
     
         4 . The method of  claim 1 , wherein said electron beam radiation is low level electron beam radiation.  
     
     
         5 . The method of  claim 4 , wherein said low level electron beam radiation ranges from about 5 to 19 kGy.  
     
     
         6 . The method of  claim 4 , wherein said low level electron beam radiation ranges from about 8 to 15 kGy.  
     
     
         7 . The method of  claim 1 , wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.  
     
     
         8 . A method of producing a sealed, terminally sterilized topical patch preparation, said method comprising: 
 (a) producing a sealed topical patch preparation by the method comprising: 
 (i) providing a topical patch preparation;  
 (ii) packaging said topical patch preparation in packaging material comprising an aluminum layer; and  
 (iii) sealing said packaged topical patch preparation; and  
   (b) exposing said sealed topical patch preparation to low level electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation;    whereby a sealed, terminally sterilized topical patch preparation is produced.    
     
     
         9 . The method of  claim 8 , wherein said low level electron beam radiation ranges from about 5 to 19 kGy.  
     
     
         10 . The method of  claim 8 , wherein said low level electron beam radiation ranges from about 8 to 15 kGy.  
     
     
         11 . The method of  claim 8 , wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.  
     
     
         12 . A terminally sterilized topical patch preparation produced according to the method of  claim 1 .  
     
     
         13 . A terminally sterilized topical patch preparation, said preparation comprising: 
 a fibrous material; and    an adhesive gel composition;    wherein said preparation contains nonviable microorganisms.    
     
     
         14 . The preparation of  claim 13 , wherein said adhesive gel composition comprises: 
 an active agent;    a water-soluble polymer gel;    water; and    a water holding agent.    
     
     
         15 . The preparation of  claim 14 , wherein said active agent is a local anesthetic.  
     
     
         16 . The preparation of  claim 13 , wherein said preparation is sealed in packaging material.  
     
     
         17 . The preparation of  claim 16 , wherein said packaging material comprises an aluminum layer.  
     
     
         18 . The preparation of  claim 14 , wherein said nonviable microorganisms are electron beam irradiated microorganisms.  
     
     
         19 . A method of delivering an active agent to a subject, said method comprising: 
 applying a terminally sterilized topical patch preparation comprising an active agent to a skin surface of said subject;    whereby said active ingredient is delivered to a subject.    
     
     
         20 . The method of  claim 19 , wherein said preparation is the preparation of  claim 14 .  
     
     
         21 . A kit for use in transdermal delivery of an active agent to a subject in need thereof, said kit comprising: 
 (a) a terminally sterilized topical patch preparation comprising an active agent; and    (b) instructions for using said preparation to practice the method of  claim 19 .    
     
     
         22 . A method of producing a terminally sterilized topical patch preparation, said method comprising: 
 exposing a water-containing topical patch preparation to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation, to produce a terminally sterilized topical patch preparation.    
     
     
         23 . The method of  claim 22 , wherein said topical patch preparation is sealed in a packaging material containing an aluminum layer.  
     
     
         24  The method of  claim 23 , wherein said sealed topical patch preparation is produced by: 
 (a) providing a topical patch preparation;  
 (b) packaging said topical patch preparation in packaging material comprising an aluminum layer; and  
 (c) sealing said packaged topical patch preparation.  
 
     
     
         25 . The method of  claim 22 , wherein said electron beam radiation is low level electron beam radiation.  
     
     
         26 . The method of  claim 22 , wherein said preparation is exposed for a period of time ranging from about 40 to 80 sec.  
     
     
         27 . The method according to  claim 22 , wherein said water-containing topical patch preparation comprises a water-soluble polymer, water and a water holding agent.  
     
     
         28 . A terminally sterilized topical patch preparation produced according to the method of  claim 22 .  
     
     
         29 . A method of producing a terminally heat sterilized adhesive gel composition, said method comprising: 
 exposing an adhesive gel composition to electron beam radiation for a period of time sufficient to terminally sterilize said topical patch preparation;    whereby a terminally sterilized adhesive gel composition is produced.    
     
     
         30 . The method of  claim 29 , wherein said adhesive gel composition comprises a pharmaceutically active agent.  
     
     
         31 . The method of  claim 30 , wherein said pharmaceutically active agent is present in said adhesive gel composition in an amount ranging from about 0.2 to about 10.0%.  
     
     
         32 . The method of  claim 30 , wherein said pharmaceutically active agent is a local anesthetic.  
     
     
         33 . The method of  claim 29 , wherein said adhesive gel composition comprises: 
 (a) a water-soluble polymer gel;    (b) water; and    (c) a water retaining agent.    
     
     
         34 . The method of  claim 29 , wherein said adhesive gel composition is sealed in a packaging material comprising an aluminum layer.  
     
     
         35 . The method of  claim 34 , wherein said sealed adhesive gel composition is produced by: 
 (a) providing an adhesive gel composition;    (b) packaging said adhesive gel composition in a packaging material comprising an aluminum layer; and    (c) sealing said packaged adhesive gel composition in said packaging material.    
     
     
         36 . The method of  claim 29 , wherein said electron beam radiation is low level electron beam radiation.  
     
     
         37 . The method of  claim 36 , wherein said low level electron beam radiation ranges from about 5 to about 19 kGy.  
     
     
         38 . The method of  claim 29 , wherein said preparation is exposed for a period of time ranging from about 40 to about 80 seconds.