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Claims for Patent: 8,993,520

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Claims 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 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.
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