Method and composition for transdermal drug delivery

Abstract

The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.

1 .- 20 . (canceled) 
     
     
         21 . A method of treatment of androgen deficiency in an adult male subject, comprising topically administering to at least one axilla of the subject a composition comprising:
 (a) testosterone;   (b) from 40 to 99% v/v of a volatile solvent carrier selected from ethanol, ethyl acetate, isopropanol and mixtures thereof; and   (c) from 0.1% to 15% w/v of at least one sunscreen ester penetration enhancer.   
     
     
         22 . A method according to  claim 21 , wherein the sunscreen ester penetration enhancer is selected from the group consisting of octyl dimethyl-para-aminobenzoate, octyl paramethoxycinnamate, octyl salicylate and mixtures thereof. 
     
     
         23 . A method according to  claim 21 , wherein the sunscreen ester penetration enhancer is octyl salicylate 
     
     
         24 . A method according to  claim 21 , wherein the composition is administered without covering the composition with a physical barrier bonded to the administration area. 
     
     
         25 . A method according to  claim 21 , wherein the volatile solvent carrier is ethanol, isopropanol or a mixture thereof. 
     
     
         26 . A method according to  claim 21 , wherein the composition is administered in an amount to provide a serum testosterone level of 300-1000 ng/dL. 
     
     
         27 . A method according to  claim 21 , wherein the composition further comprises from 1-5% w/v of a thickener. 
     
     
         28 . A method according to  claim 27 , wherein the thickener is polyvinylpyrrolidone. 
     
     
         29 . A method according to  claim 21 , wherein the composition has an in vitro drying time of less than three minutes. 
     
     
         30 . A method of treatment of androgen deficiency in an adult male subject comprising topically administering to at least one axilla of the subject a composition comprising:
 (a) testosterone;   (b) from 40 to 99% v/v of a volatile solvent carrier selected from ethanol, ethyl acetate, isopropanol and mixtures thereof;   (c) from 0.1% to 15% w/v of at least one sunscreen ester penetration enhancer; and   (d) from 1-5% w/v polyvinylpyrrolidone.   
     
     
         31 . A method according to  claim 30 , wherein the sunscreen ester penetration enhancer is selected from the group consisting of octyl dimethyl-para-aminobenzoate, octyl paramethoxycinnamate, octyl salicylate and mixtures thereof. 
     
     
         32 . A method according to  claim 31 , the wherein the sunscreen ester penetration enhancer is octylsalicylate. 
     
     
         33 . A composition for transdermal delivery of testosterone to at least one axilla of a subject comprising:
 (a) testosterone;   (b) from 40% to 99% v/v of a volatile solvent carrier selected from ethanol, ethyl acetate, isoproponol and mixtures thereof; and   (c) from 0.1% to 15% w/v of at least one sunscreen ester penetration enhancer; and   (d) from 1-5% w/v polyvinylpyrrolidone.   
     
     
         34 . A composition according to  claim 33 , wherein the sunscreen ester penetration enhancer is selected from the group consisting of octyl dimethyl-para-aminobenzoate, octyl paramethoxycinnamate, octyl salicylate and mixtures thereof. 
     
     
         35 . A composition according to  claim 33 , wherein the sunscreen ester penetration enhancer is octyl salicylate 
     
     
         36 . A composition according to  claim 34 , wherein the volatile solvent carrier is ethanol, isopropanol or a mixture thereof. 
     
     
         37 . A composition according to  claim 33 , wherein the composition has an in vitro drying time of less than three minutes. 
     
     
         38 . A composition according to  claim 33 , wherein the volatile solvent carrier is selected from ethanol, isoproponol and a mixture thereof, and the sunscreen ester penetration enhancer is octyl salicylate.