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Details for Patent: 6,071,531

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Details for Patent: 6,071,531

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.
Inventor(s): Jona; Janan (Sunnyvale, CA), Audett; Jay (Mountain View, CA), Singh; Noel (San Francisco, CA)
Assignee: Ortho-McNeil Pharmaceutical, Inc. (Raritan, NJ)
Filing Date:Jun 28, 1999
Application Number:09/340,859
Claims:1. A method for fabricating a laminated structure capable of being used in a contraceptive transdermal patch, the method comprising:

a) formulating a matrix comprising a nonacrylate polymer, 17-deacetyl norgestimate, an enhancer, and a solvent;

b) casting the matrix onto a backing layer;

c) removing the solvent from the matrix; and

d) applying a release liner to the matrix to form a laminated structure,

wherein the nonacrylate polymer is selected from the group consisting of polyisobutylene and silicone, and wherein the enhancer is selected from the group consisting of lactate esters of C.sub.12 to C.sub.18 aliphatic alcohols, propylene glycol monolaurate (PGML) and combinations thereof.

2. The method of claim 1, wherein the matrix further comprises polyvinyl pyrrolidone.

3. The method of claim 1, wherein the matrix further comprises an estrogen.

4. The method of claim 3, wherein the estrogen is selected from the group consisting of 17-.beta.-estradiol, ethinyl estradiol, estradiol valerate, estradiol cypionate, estradiol acetate, and estradiol benzoate.

5. The method of claim 4, wherein the estrogen comprises ethinyl estradiol.

6. The method of claim 5, wherein the lactate ester of C.sub.12 to C.sub.18 aliphatic alcohol enhancer comprises lauryl lactate.

7. The method of claim 6, wherein the matrix further comprises polyvinyl pyrrolidone.

8. A method for fabricating a laminated structure capable of being used in a contraceptive transdermal patch, the method comprising:

a) formulating a matrix comprising a nonacrylate polymer, 17-deacetyl norgestimate, an enhancer, and a solvent;

b) casting the matrix onto a release liner;

c) removing the solvent from the matrix; and

d) applying a backing layer to the matrix to form a laminated structure

wherein the nonacrylate polymer is selected from the group consisting of polyisobutylene and silicone, and wherein the enhancer its selected from the group consisting of lactate esters of C.sub.12 to C.sub.18 aliphatic alcohols, propylene glycol monolaurate (PGML), and combinations thereof.

9. The method of claim 8 wherein the matrix further comprises polyvinyl pyrrolidone.

10. The method of claim 8 wherein the matrix further comprises an estrogen.

11. The method of claim 10, wherein the estrogen is selected from the group consisting of 17-.beta.-estradiol, ethinyl estradiol, estradiol valerate, estradiol cypionate, estradiol acetate, and estradiol benzoate.

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

13. The method of claim 12, wherein the lactate esters of C.sub.12 to C.sub.18 aliphatic alcohol enhancer comprises lauryl lactate.

14. The method of claim 13, wherein the matrix further comprises polyvinyl pyrrolidone.

15. A method for fabricating a laminated structure capable of being used in a contraceptive transdermal patch, the method comprising:

a) formulating a matrix comprising a nonacrylate polymer, 17-deacetyl norgestimate, and an enhancer, wherein the nonacrylate polymer is selected from the group consisting of polyisobutylene and silicone, and wherein the enhancer is selected from the group consisting of lactate esters of C.sub.12 to C.sub.18 aliphatic alcohols, propylene glycol monolaurate (PGML), and combinations thereof;

b) applying a backing layer to the matrix; and

c) applying a release liner to the matrix,

wherein the backing layer, the matrix, and the release liner form a laminated structure.

16. The method of claim 15, wherein step c) precedes step b).

17. The method of claim 15, wherein the matrix further comprises polyvinyl pyrrolidone.

18. The method of claim 15 wherein the matrix further comprises an estrogen.

19. The method of claim 18, wherein the estrogen is selected from the group consisting of 17-.beta.estradiol, ethinyl estradiol, estradiol valerate, estradiol cypionate, estradiol acetate, and estradiol benzoate.

20. The method of claim 19, wherein the estrogen comprises ethinyl estradiol.

21. The method of claim 20, wherein the lactate esters of C.sub.12 to C.sub.18 aliphatic alcohol enhancer comprises lauryl lactate.

22. The method of claim 21, wherein the matrix further comprises polyvinyl pyrrolidone.

23. The laminated structure as prepared by the method of claim 1.

24. The laminated structure as prepared by the method of claim 8.

25. The laminated structure as prepared by the method of claim 15.
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