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Claims for Patent: 5,876,746

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Claims for Patent: 5,876,746

Title: Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen
Abstract:Compositions and methods for preventing ovulation in a woman are provided, as well as compositions and methods for female hormone replacement therapy. The compositions can be administered by the use of a transdermal patch. The patch will administer 17-deacetyl norgestimate alone or in combination with an estrogen such as ethinyl estradiol to women via an adhesive matrix of a silicone and/or polyisobutylene.
Inventor(s): Jona; Janan (Sunnyvale, CA), Audett; Jay (Mountain View, CA), Singh; Noel (San Francisco, CA)
Assignee: Cygnus, Inc. (Redwood City, CA)
Application Number:08/660,024
Patent Claims: 1. A transdermal patch for preventing ovulation in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, lauryl lactate, and a pressure sensitive adhesive comprising at least one of a silicone and polyisobutylene, and being adapted to be in diffusional communication with the skin of the woman and to administer an ovulation-inhibiting amount of 17-deacetyl norgestimate.

2. The patch of claim 1 wherein said amount is 150 to 350 .mu.g/day.

3. The patch of claim 1 wherein the pressure sensitive adhesive consists essentially of polyisobutylene and an aliphatic tackifier.

4. A transdermal patch for preventing ovulation in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, an estrogen selected from the group consisting of ethinyl estradiol and 17-.beta.-estradiol, lauryl lactate, and a pressure sensitive adhesive consisting essentially of polyisobutylene and an aliphatic tackifier, and being adapted to be in diffusional communication with the skin of a woman and to co-administer an ovulation inhibiting amount of 17-deacetyl norgestimate and estrogen to said woman.

5. The patch of claim 4 wherein the estradiol is ethinyl estradiol.

6. The patch of claim 5 wherein said amount is 150 to 350 .mu.g/day of 17-deacteyl norgestimate and from 10 to 35 .mu.g/day of ethinyl estradiol.

7. The patch of claim 4 where the estradiol is 17-.beta.-estradiol.

8. The patch of claim 7 wherein said amount is 150 to 350 .mu.g/day of 17-deacetyl norgestimate and from 30-150 .mu.g/day of 17-.beta.-estradiol.

9. A method of preventing ovulation in a woman comprising affixing to the skin of the woman the transdermal patch of claim 1.

10. The method of claim 9 wherein said amount is 150 to 350 .mu.g/day.

11. A method of preventing ovulation in a woman comprising affixing to the skin of the woman the transdermal patch of claim 7.

12. The method of claim 11 wherein the estrogen is ethinyl estradiol.

13. The method of claim 12, wherein said amount is 150 to 350 .mu.g/day of 17 deacteyl norgestimate and from 10 to 35 .mu.g/day of ethinyl estradiol.

14. A transdermal patch for providing hormone replacement therapy in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, an estrogen selected from the group consisting of ethinyl estradiol and 17-.beta.-estradiol, lauryl lactate, and a pressure sensitive adhesive consisting essentially of polyisobutylene and an aliphatic tackifier, and being adapted to be in diffusional communication with the skin of a woman and to co-administer a therapeutic amount of 17-deacetyl norgestimate and estrogen to said skin.

15. The patch of claim 14 wherein the estradiol is ethinyl estradiol.

16. The patch of claim 14 wherein the estradiol is 17-.beta.-estradiol.

17. A method of providing hormone replacement therapy in a woman comprising affixing to the skin of the woman the transdermal patch of claim 14.

18. The method of claim 17 wherein the estrogen is ethinyl estradiol.

19. The method of claim 17 wherein said amount of 17 deacetyl norgestimate is about 150 to 350 .mu.g/day and the amount of ethinyl estradiol is from about 10 to 35 .mu.g/day.

20. The patch of claim 3 wherein the tackifier comprises polybutene oil.

21. The patch of claim 3 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

22. The patch of claims 2 or 3 wherein the patch transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate for 7 consecutive days.

23. The patch of claim 4 wherein the tackifier comprises polybutene oil.

24. The patch of claim 4 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

25. The patch of claim 4 wherein the patch transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate and a therapeutically effective amount of estrogen for 7 consecutive days.

26. The method of claim 10 wherein the pressure sensitive adhesive consists essentially of polyisobutylene and an aliphatic tackifier.

27. The method of claims 10 or 26 wherein the matrix transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate for 7 consecutive days.

28. The method of claim 11 wherein the matrix transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate and a therapeutically effective amount of estrogen for 7 consecutive days.

29. The patch of claim 14 wherein the tackifier comprises polybutene oil.

30. The patch of claim 14 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

31. A transdermal patch comprising:

a backing layer; and

a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, crosslinked polyvinyl pyrrolidone, and a pressure sensitive adhesive consisting essentially of polyisobutylene and an aliphatic resin tackifier, wherein the matrix is adapted to be in diffusional communication with skin to transdermally administer a therapeutically effective amount of 17-deacetyl norgestimate for 7 consecutive days.

32. The patch of claim 31 wherein the therapeutically effective amount of 17-deacetyl norgestimate prevents ovulation.

33. The patch of claim 31 wherein the matrix administers from 150 to 350 .mu.g/day of 17-deacetyl norgestimate.

34. The patch of claim 31 wherein the tackifier comprises polybutene oil.

35. The patch of claim 31 wherein the matrix further comprises a skin permeation enhancer.

36. The patch of claim 35 wherein the skin permeation enhancer comprises lauryl lactate.

37. The patch of claim 31 wherein the matrix further comprises an estrogen.

38. The patch of claim 37 wherein the estrogen comprises ethinyl estradiol.

39. A method for transdermally administering 17-deacetyl norgestimate by applying the transdermal patch of claim 31 to the skin of a patient such that the matrix is in diffusional communication with the skin.

40. The method of claim 39 wherein the transdermal administration of 17-deacetyl norgestimate is effective to prevent ovulation.

41. The method of claim 39 wherein the transdermal administration of 17-deacetyl norgestimate is effective to provide hormone therapy.
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