Claims for Patent: 8,435,944

Summary for Patent: 8,435,944

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:	11/445,463
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,435,944
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 non-occlusive transdermal drug delivery composition consisting of: (a) a pharmaceutically effective amount of testosterone; (b) one or more lower alkyl alcohols, wherein the combined volume of the lower alkyl alcohols is more than 60% (v/v) of the composition; (c) one or more penetration enhancers selected from the group consisting of glycols, oleic acid, isopropyl myristate, cyclopentadecanone, sorbitan monooleate, octisalate, octyldimethyl-para-aminobenzoate, octyl para-methoxycinnamate, and combinations thereof; (d) one or more viscosity modulating agents; (e) optionally, an activator for the viscosity modulating agent; (f) optionally, an antiperspirant and/or deodorant agent; and (g) optionally, water wherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL. 2. The method of claim 1, wherein the adult male subject is suffering from androgen deficiency. 3. The method of claim 1, wherein the lower alkyl alcohol is selected from the group consisting of ethanol, isopropanol, and mixtures thereof, and wherein the combined volume of the lower alkyl alcohol(s) is more than 70% (v/v) of the composition. 4. The method of claim 3, wherein the combined volume of lower alkyl alcohol(s) is more than 80% (v/v) of the composition. 5. The method of claim 1, wherein the penetration enhancer is one or more selected from the group consisting of octyl dimethyl-para-aminobenzoate, octyl para-methoxycinnamate and octisalate. 6. The method of claim 1, wherein the penetration enhancer is octisalate. 7. The method of claim 1, wherein the viscosity modulating agent is selected from the group consisting of polyvinyl pyrrolidone and hydroxypropyl methyl cellulose. 8. The method of claim 1, wherein the viscosity modulating agent is polyvinyl pyrrolidone and is present in an amount of from 1% to 3% (w/v) of the composition. 9. The method of claim 1, wherein the amount of viscosity modulating agent is effective to increase the viscosity of the composition to within the range of from greater than the viscosity of water to less than 300 centipoise. 10. The method of claim 1, wherein the penetration enhancer is present in an amount of from 0.01 to 15% (w/v) of the composition. 11. The method of claim 1, wherein the penetration enhancer is isopropyl myristate. 12. The method of claim 11, wherein the lower alkyl alcohol is selected from the group consisting of ethanol, isopropanol, and mixtures thereof, and wherein the combined volume of lower alkyl alcohol(s) is more than 70% (v/v) of the composition. 13. 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 consisting of: (a) a pharmaceutically effective amount of testosterone; (b) one or more lower alkyl alcohols, wherein the combined volume of the lower alkyl alcohol(s) is more than 60% (v/v) of the composition; (c) one or more penetration enhancers selected from the group consisting of octisalate, octyldimethyl-para-aminobenzoate and octyl para-methoxycinnamate; (d) one or more viscosity modulating agents, in an amount effective to increase the viscosity of the composition to within the range of from greater than the viscosity of water to less than 300 centipoise; and (e) optionally, water wherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL. 14. The method of claim 13 wherein the penetration enhancer is present in an amount of from 0.01% to 15% (w/v) of the composition. 15. The method of claim 14 wherein the penetration enhancer is octisalate. 16. The method of claim 15, wherein the lower alkyl alcohol is selected from the group consisting of ethanol, isopropanol, and mixtures thereof. 17. The method of claim 16 wherein the combined volume of lower alkyl alcohol(s) is more than 70% (v/v). 18. The method of claim 17 wherein the combined volume of lower alkyl alcohols(s) is more than 80% (v/v). 19. The method of claim 18 wherein the viscosity modulating agent is polyvinyl pyrrolidone. 20. The method of claim 19 wherein the polyvinyl pyrrolidone is present in an amount of from 1% to 3% (w/v) of the composition. 21. The method of claim 13, wherein the adult male subject is suffering from androgen deficiency.