Multi-polymer compositions for transdermal drug delivery

Abstract

Multi-polymer compositions for the transdermal delivery of drugs, such as amine-functional drugs, in a flexible, finite form are described. The compositions comprise a polymer matrix that includes a drug or a pharmaceutically acceptable salt thereof and a polymer matrix comprising acrylic polymer(s), polyisobutylene polymer(s) and styrene-isoprene-styrene block copolymer(s). Methods of manufacturing and methods of using the compositions also are described.

What is claimed is: 
     
         1 . A multi-polymer composition for the transdermal delivery of an amine-functional drug in the form of a flexible finite system for topical application, comprising a polymer matrix comprising (i) a therapeutically effective amount of an amine-functional drug; (ii) an acrylic polymer; (iii) a polyisobutylene polymer, and (iv) a styrene-isoprene-styrene block copolymer. 
     
     
         2 . The composition of  claim 1 , wherein the amine-functional drug comprises clonidine. 
     
     
         3 . The composition of  claim 1 , wherein the polymer matrix comprises two or more acrylic polymers. 
     
     
         4 . The composition of  claim 1 , wherein the polymer matrix comprises a non acid-functional acrylic polymer. 
     
     
         5 . The composition of  claim 1 , wherein the polymer matrix comprises about 1% to 10% w/w clonidine. 
     
     
         6 . The composition of  claim 1 , wherein the polymer matrix comprises about 85% to 95% w/w acrylic polymer. 
     
     
         7 . The composition of  claim 1 , wherein the polymer matrix comprises about 3% to 5% w/w polyisobutylene polymer. 
     
     
         8 . The composition of  claim 1 , wherein the polymer matrix comprises about 1% to 2% w/w styrene-isoprene-styrene block copolymer. 
     
     
         9 . The composition of  claim 1 , wherein the polymer matrix has a coat weight of about 10 to 15 mg/cm 2 . 
     
     
         10 . The composition of  claim 1 , wherein the system achieves delivery of the amine-functional drug over a period of time of about 24 hours. 
     
     
         11 . The composition of  claim 1 , wherein the system achieves delivery of the amine-functional drug over a period of time of about 7 days. 
     
     
         12 . The composition of  claim 1 , further comprising a backing layer. 
     
     
         13 . The composition of  claim 1 , further comprising a release liner. 
     
     
         14 . A method for the transdermal delivery of an amine-functional drug, comprising topically applying a composition according to  claim 1  to the skin or mucosa of a subject in need thereof. 
     
     
         15 . A method for the manufacture of a composition as claimed in  claim 13 , comprising:
 optionally, drying one or more of an acrylic polymer, a polyisobutylene polymer, and a styrene-isoprene-styrene block copolymer to remove any solvent;   dissolving an acrylic polymer, a polyisobutylene polymer, and a styrene-isoprene-styrene block copolymer in a solvent miscible with the amine-functional drug and polymer components and mixing to form a polymer blend;   adding the amine-functional drug to the polymer blend and mixing to form a polymer matrix;   applying the polymer matrix to a release liner;   removing solvent from the polymer matrix; and   providing the polymer matrix with a backing layer.   
     
     
         16 . The method of  claim 15 , wherein the amine-functional drug is clonidine and the solvent is toluene.