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Claims for Patent: 5,770,219

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Claims for Patent: 5,770,219

Title: Solid matrix system for transdermal drug delivery
Abstract:A matrix for containing drugs for transdermal delivery systems is disclosed. The matrix, formed of a skin-adhesive acrylate copolymer, attains high rates of drug delivery without the addition of drug delivery rate enhancers. In preferred embodiments the matrix is used to administer steroids, in particular estradiol. Water-soluble polymers may be added as well.
Inventor(s): Chiang; Chia-Ming (Foster City, CA), Tenzel; Renee Ann (Mountain View, CA)
Assignee: Cygnus Inc. (Redwood City, CA)
Application Number:08/311,914
Patent Claims: 1. A drug-containing matrix for use in a transdermal drug delivery device for administering at least one estrogen to an area of skin or mucosa comprising the estrogen dispersed in a body of a pressure sensitive adhesive, said pressure-sensitive adhesive comprising an acetate acrylate copolymer and polyvinylpyrrolidone, said matrix being essentially free of a skin permeation enhancer.

2. The matrix of claim 1, wherein the estrogen is dispersed in the pressure sensitive adhesive in an amount at or below saturation.

3. The matrix of claim 1, wherein the acrylate copolymer comprises 2-ethylhexyl acrylate.

4. The matrix of claim 1, wherein the copolymer comprises at least one comonomer selected from the group consisting of vinyl acetate, acrylic acid and methyl acrylate.

5. The matrix of claim 4, wherein the copolymer comprises 2-ethylhexyl acrylate and vinyl acetate.

6. The matrix of claim 5, wherein the copolymer comprises approximately 72 wt % 2-ethylhexyl acrylate and approximately 28 wt % vinyl acetate.

7. The matrix of claim 3, wherein the copolymer comprises approximately 70 wt % 2-ethylhexyl acrylate and approximately 28 wt % vinyl acetate.

8. The matrix of claim 3, wherein the copolymer comprises approximately 85 wt % 2-ethylhexyl acrylate and approximately 10 wt % methyl acrylate, approximately 3 wt % acrylic acid and approximately 2 wt % vinyl acetate.

9. The matrix of claim 1, wherein the estrogen is selected from the group consisting of estradiol, ethinyl estradiol, esters of estradiol or a combination thereof.

10. The matrix of claim 1, further comprising a progestogen.

11. The matrix of claim 9 or 10, wherein the estrogen is estradiol.

12. The matrix of claim 9, wherein the estradiol ester is selected from the group consisting of estradiol valerate, estradiol cyprionate, estradiol decanoate and estradiol acetate.

13. The matrix of claim 11, wherein the progestogen is selected from the group consisting of norethindrone, norethindrone acetate, desogestrel, 3-keto desogestrel, gestadene and levonorgestrel.

14. The matrix of claim 13, wherein the progestogen is norethindrone acetate.

15. The matrix of claim 1, wherein the estrogen is estradiol.

16. The matrix of claim 10, wherein the estrogen is estradiol and the progestogen is norethindrone acetate.

17. The matrix of claim 1, wherein the copolymer comprises approximately 70 wt % 2-ethylhexyl acrylate and approximately 28 wt % vinyl acetate and the estrogen is estradiol.

18. The matrix of claim 10, wherein the copolymer comprises approximately 70 wt % 2-ethylhexyl acrylate and approximately 28 wt % vinyl acetate, the estrogen is estradiol and the progestogen is norethindrone acetate.

19. A transdermal or transmucosal drug delivery device for administering at least one steroid drug to an area of skin or mucosa comprising:

(a) a layer of backing material which is substantially impermeable to the drug and laminated thereto; and

(b) an adhesive drug-containing matrix as defined in any of claims 1, 10, 17 or 18.

20. A method for delivering a estrogen comprising applying the matrix of the device of claim 19 to the skin or mucosa of said patient.
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