Packaging materials for transdermal drug delivery systems

Abstract

Compositions and methods for producing laminate materials in packaging a transdermal drug delivery system comprising a rubber modified acrylonitrile methyl acrylate copolymer film, alone or in combination with a polyester film, wherein the active drug incorporated in the transdermal system remains substantially solubilized and stable in the system during storage prior to use. The packaging laminate is preferably translucent to allow visual inspection of its contents, and has sufficient tear resistance to substantially provide child resistant and/or proof properties.

What is claimed is:  
     
         1 . A method of inhibiting the loss of the active enantiomers of a chiral drug in a carrier composition of a transdermal system, comprising the steps of: 
 providing a laminate package material comprising: 
 (i) an inner layer comprising a thermoplastic polymer film, wherein said layer is free of polyolefins, metal foil and vinyl acetate; and  
 (ii) an outer layer affixed to said inner layer;  
   providing a non-aqueous carrier composition of a transdermal system comprising a chiral drug or active enantiomers thereof that degrades or is unstable when exposed to vinyl acetate and metal foil materials;    placing said carrier composition within a pouch of the laminate packaging material; and    sealing said pouch along one or more edges of the inner layer, wherein the chiral drug or active enantiomers thereof excludes nicotine.    
     
     
         2 . A method according to  claim 1 , wherein the inner layer of the laminate packaging material is self-sealing.  
     
     
         3 . A method according to  claim 1 , wherein the inner layer is a film of rubber modified acrylonitrile methyl acrylate copolymers.  
     
     
         4 . A method according to  claim 3 , wherein the outer layer comprises at least one polyester film affixed to the inner layer.  
     
     
         5 . A method according to  claim 4 , wherein the outer layer is affixed to the inner layer by means of an adhesive.  
     
     
         6 . A method according to  claim 1 , wherein the laminate packaging material is child resistant.  
     
     
         7 . A method according to  claim 1 , wherein the laminate packaging material is translucent.  
     
     
         8 . A method according to  claim 1 , wherein the chiral drug is selected from the group consisting of methylphenidate, a pharmaceutically acceptable salt or base of methylphenidate, and active enantiomers thereof.