Claims for Patent: 8,993,520

Summary for Patent: 8,993,520

Title:	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.
Inventor(s):	Dipietro; Tony (Victoria, AU), Humberstone; Andrew (Victoria, AU), Gonda; Igor (South Yarra, AU), Watkinson; Adam (Victoria, AU), Setiawan; Kerrie (Victoria, AU), Wilkins; Nina (Victoria, AU)
Assignee:	Acrux DDS Pty Ltd (West Melbourne, Victoria, AU)
Application Number:	12/823,448
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,993,520
Patent Claims:	1. A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla of the subject, without occlusion by a patch device, a transdermal drug delivery composition comprising: (a) a pharmaceutically effective amount of testosterone; (b) one or more lower alkyl alcohols, wherein the combined amount of lower alkyl alcohols is more than 60% v/v of the composition; (c) one or more penetration enhancers selected from the group consisting of oleic acid, fatty acid esters, fatty alcohols, glycols, glycol esters, 1,3-dioxolanes, 1,3-dioxanes, macrocyclic ketones containing at least 12 carbon atoms, oxazolidinones, alkyl-2-(N,N-disubstituted amino)-alkanoate esters, (N,N-disubstituted amino)-alkanol alkanoates, sunscreen esters and mixtures thereof; and (d) a viscosity modulating agent for increasing the viscosity of the composition. 2. A method according to claim 1 wherein the penetration enhancer is one or more selected from the group consisting of octyl dimethyl-para-aminobenzoate, octyl para-methyoxycinnamate and octyl salicylate. 3. A method according to claim 1 wherein the penetration enhancer is octyl salicylate. 4. A method according to claim 1 wherein the penetration enhancer is present in an amount of from 0.01% to 15% w/v based on the total volume of the composition. 5. A method according to claim 4 wherein the lower alkyl alcohol is selected from the group consisting of ethanol, isopropanol, and mixtures thereof. 6. A method according to claim 5 wherein the lower alkyl alcohol is present in an amount of more than 80% v/v of the composition. 7. A method according to claim 1 wherein the adult male subject is suffering from androgen deficiency. 8. A method according to claim 1 wherein the viscosity modulating agent increases the viscosity of the composition to within the range of from greater than the viscosity of water to 300 cps. 9. A method according to claim 1 wherein the viscosity modulating agent is polyvinyl pyrrolidone and is present in an amount between 1% and 3% w/v. 10. A method according to claim 1 wherein the composition is applied once a day. 11. A method according to claim 1 wherein the testosterone is present in an amount of at least 1% w/v of the composition. 12. A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla of the subject, without occlusion by a patch device, a non-occlusive transdermal drug delivery composition comprising: (a) a pharmaceutically effective amount of testosterone; (b) a lower alkanol selected from the group consisting of ethanol, isopropanol and mixtures thereof in a total amount of more than 60% by weight of the composition; (c) one or more penetration enhancers selected from the group consisting of octyl dimethyl para-aminobenzoate, octyl para-methoxycinnamate and octyl salicylate; and (d) a viscosity modulating agent for increasing the viscosity of the composition. 13. A method according to claim 12 wherein the penetration enhancer is octyl salicylate. 14. A method according to claim 13 wherein the total amount of the one or more penetration enhancers is in the range of from 0.01% w/v to 15% w/v. 15. A method according to claim 13 wherein the thickening agent provides a viscosity of the composition in the range of from the viscosity of water to 300 cps. 16. A method according to claim 15 wherein the thickening agent is polyvinyl pyrrolidone. 17. A method according to claim 16 wherein the polyvinyl pyrrolidone is present in an amount of from 1% w/v to 3% w/v of the composition. 18. A method according to claim 12 wherein the testosterone is present in an amount of at least 1% w/v of the composition. 19. A method according to claim 12 wherein the adult male subject is suffering from androgen deficiency.