Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions

Abstract

The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.

What is claimed is: 
     
         1 . An edible film for delivery of an active comprising:
 an edible, water-soluble polymer;   at least one anti-tacking agent selected from the group consisting of lubricants, antiadherants, glidants and combinations thereof; and   an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof,   wherein said film is self-supporting.   
     
     
         2 . The film of  claim 1 , wherein said anti-tacking agent comprises Vitamin E TPGS. 
     
     
         3 . The film of  claim 1 , wherein said anti-tacking agent comprises magnesium stearate. 
     
     
         4 . The film of  claim 3 , wherein said anti-tacking agent further comprises silica. 
     
     
         5 . The film of  claim 1 , wherein said anti-tacking agent is present in amounts of about 0.01% to about 20% by weight of said delivery system. 
     
     
         6 . The film of  claim 1 , wherein said anti-tacking agent comprises:
 magnesium stearate present in amounts of about 0.1% to about 2.5% by weight of said delivery system; and   silica present in amounts of about 0.1% to about 1.5% by weight of said delivery system.   
     
     
         7 . The film of  claim 1 , wherein said water-soluble polymer comprises polyethylene oxide and a cellulosic polymer. 
     
     
         8 . The film of  claim 7 , wherein said cellulosic polymer comprises hydroxypropyl cellulose. 
     
     
         9 . The film of  claim 7 , wherein said cellulosic polymer comprises hydroxypropylmethyl cellulose. 
     
     
         10 . The film of  claim 1 , wherein said active component comprises dextromethorphan. 
     
     
         11 . The film of  claim 1 , further comprising polydextrose. 
     
     
         12 . The film of  claim 1 , wherein said film is applied to an oral cavity of a mammal. 
     
     
         13 . The film of  claim 13 , wherein said film adheres to the tongue of the mammal. 
     
     
         14 . An edible film for delivery of an active comprising:
 an edible, water-soluble polymer component comprising at least one polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, polyethylene oxide and combinations thereof;   an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof; and   an anti-tacking agent comprising Vitamin E TPGS present in amounts of about 0.01% to about 20% by weight of said film.   
     
     
         15 . An edible film for delivery of an active comprising:
 an edible, water-soluble polymer component comprising polyethylene oxide in combination with a polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose and combinations thereof; and   Vitamin E TPGS present in amounts sufficient to provide anti-tacking and therapeutic properties,   wherein said film is self-supporting.   
     
     
         16 . An edible film for delivery of an active comprising:
 an edible, water-soluble polymer comprising polyethylene oxide and hydroxypropyl cellulose;   polydextrose, wherein said polyethylene oxide, hydroxypropyl cellulose and polydextrose are present in a ratio of about 45:45:10;   an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof; and   at least one anti-tacking agent.   
     
     
         17 . An edible film for delivery of an active comprising:
 (a) a self-supporting film having at least one surface, said film comprising:
 (i) an edible, water-soluble polymer; and 
 (ii) an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof; and 
   (b) a coating on said at least one surface of said self-supporting film, said coating comprising at least one anti-tacking agent.   
     
     
         18 . A multi-layer film for delivery of an active comprising:
 (a) at least one first film layer comprising:
 (i) an edible, water-soluble polymer; and 
 (ii) an anti-tacking agent; and 
   (b) a second film layer comprising:
 (i) an edible, water-soluble polymer; and 
 (ii) an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof, 
   wherein said first film layer is substantially in contact with said second film layer.   
     
     
         19 . The multi-layer film of  claim 18 , wherein said first film layer is laminated to said second film layer. 
     
     
         20 . A process for making a self-supporting film having a substantially uniform distribution of components comprising:
 (a) combining an edible, water-soluble polymer, a solvent, an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent to form a matrix with a uniform distribution of said components;   (b) forming a self-supporting film from said matrix;   (c) providing a surface having top and bottom sides;   (d) feeding said film onto said top side of said surface; and   (e) drying said film by applying heat to said bottom side of said surface.   
     
     
         21 . The process of  claim 20 , wherein said anti-tacking agent comprises Vitamin E TPGS. 
     
     
         22 . The process of  claim 20 , wherein said anti-tacking agent comprises magnesium stearate and silica. 
     
     
         23 . The process of  claim 20 , wherein said matrix further comprises polydextrose. 
     
     
         24 . The process of  claim 20 , wherein said film is ingestible. 
     
     
         25 . The process of  claim 20 , wherein said film is flexible when dried. 
     
     
         26 . The process of  claim 20 , wherein step (e) comprises applying hot air currents to said bottom side of said surface with substantially no top air flow.