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Claims for Patent: 6,579,865

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Claims for Patent: 6,579,865

Title: Penetration enhancing and irritation reducing systems
Abstract:This invention lies in the technology of transdermal and topical drug delivery. In particular, the present invention relates to enhancement of the penetration of transdermally or topically applied drugs and with the reduction of skin irritation that often accompanies transdermal and topical drug delivery.
Inventor(s): Mak; Vivien H. W. (Menlo Park, CA), Grayson; Stephen (San Rafael, CA)
Assignee: Cellegy Pharmaceuticals, Inc. (So. San Francisco, CA)
Application Number:09/963,287
Patent Claims: 1. A composition for topical application having penetration-enhancing properties consisting essentially of: a) an active agent, wherein said active agent is testosterone or derivatives thereof having a concentration of about 0.1% to about 2%; b) a penetration enhancing system consisting of (i) a membrane fluidizer comprising oleic acid; (ii) a C.sub.1 -C.sub.4 alcohol; and (iii) a glycol; and c) a gelling agent, said composition having a pH value of between about 5 to about 8.

2. A composition in accordance with claim 1, wherein said active agent is testosterone propionate.

3. A composition in accordance with claim 1, wherein said active agent is testosterone.

4. A composition in accordance with claim 1, wherein said active agent is present from about 1% to about 2% weight to weight of said composition.

5. A composition in accordance with claim 1, wherein said oleic acid is present from about 0.1% to about 10% weight to weight of said composition.

6. A composition in accordance with claim 5, wherein said oleic acid is present from about 0.1% to about 5% weight to weight of said composition.

7. A composition in accordance with claim 1, wherein said C.sub.1 -C.sub.4 alcohol is a member selected from the group consisting of ethanol, propanol, isopropanol and mixtures thereof.

8. A composition in accordance with claim 7, wherein said C.sub.1 -C.sub.4 alcohol is ethanol.

9. A composition in accordance with claim 7, wherein said C.sub.1 -C.sub.4 alcohol is propanol.

10. A composition in accordance with claim 7, wherein said C.sub.1 -C.sub.4 alcohol is isopropanol.

11. A composition in accordance with claim 7, wherein said C.sub.1 -C.sub.4 alcohol is a mixture of ethanol and isopropanol.

12. A composition in accordance with claim 1, wherein said C.sub.1 -C.sub.4 alcohol is present from about 5% to about 65% weight to weight of said composition.

13. A composition in accordance with claim 12, wherein said C.sub.1 -C.sub.4 alcohol is present from about 10% to about 40% weight to weight of said composition.

14. A composition in accordance with claim 12, wherein said C.sub.1 -C.sub.4 alcohol is present from about 25% to about 35% weight to weight of said composition.

15. A composition in accordance with claim 1, wherein said glycol is a member selected from the group consisting of ethylene glycol, propylene glycol, butylene glycol and mixtures thereof.

16. A composition in accordance with claim 15, wherein said glycol is ethylene glycol.

17. A composition in accordance with claim 15, wherein said glycol is butylene glycol.

18. A composition in accordance with claim 15, wherein said glycol is propylene glycol.

19. A composition in accordance with claim 15, wherein said glycol is a mixture of ethylene glycol and butylene glycol.

20. A composition in accordance with claim 15, wherein said glycol is a mixture of propylene glycol and butylene glycol.

21. A composition in accordance with claim 1, wherein said glycol is present from about 25% to about 55% weight to weight of said composition.

22. A composition in accordance with claim 21, wherein said glycol is present from about 30% to about 40% weight to weight of said composition.

23. A composition in accordance with claim 1, wherein said gelling agent is a member selected from the group consisting of Carbopol 1342, Carbopol 940, Klucel and Klucel HF.

24. A composition in accordance with claim 23, wherein said gelling agent is Carbopol 1342.

25. A composition in accordance with claim 1, wherein said gelling agent is present from about 0.1% to about 10% weight to weight of said composition.

26. A composition in accordance with claim 25, wherein said gelling agent is present from about 0.1% to about 5% weight to weight of said composition.

27. A composition in accordance with claim 25, wherein said gelling agent is present from about 1% to about 3% weight to weight of said composition.

28. A composition for topical application having penetration-enhancing properties consisting essentially of: a) an active agent, wherein said active agent is testosterone or derivatives thereof having a concentration of about 0.1% to about 2%; b) a penetration-enhancing system consisting of (i) a membrane fluidizer comprising oleic acid; (ii) a C.sub.1 -C.sub.4 alcohol; and (iii) a glycol; c) a gelling agent; and d) inert carriers, said composition having a pH value between about 5 to about 8.
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