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Claims for Patent: 5,840,327

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Claims for Patent: 5,840,327

Title: Transdermal drug delivery device having enhanced adhesion
Abstract:A device for the transdermal administration of a drug to a sensitive body area such as the scrotum. Devices according to the invention provide an improved quality of adhesion to the body area while also providing patient comfort during use and upon removal of the device. Also disclosed are methods of transdermal delivery such as the transcrotal delivery of testosterone to hypogonadic males.
Inventor(s): Gale; Robert M. (Los Altos, CA), Campbell; Patricia S. (Palo Alto, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:08/704,426
Patent Claims: 1. A flexible and compliant device for the transdermal administration of a drug at a therapeutically effective rate through intact skin at sensitive body areas comprising:

a) a reservoir comprising a drug selected from the group consisting of testosterone, estradiol, and progesterone dispersed throughout a non-adhesive, polymeric carrier permeable to said drug, said reservoir having a skin-facing drug transfer surface and a skin-distal surface;

b) a discontinuous pattern of adhesive on the skin-facing surface of the reservoir, said adhesive covering about 8-16% of the surface area of said reservoir skin-facing surface, said pattern of adhesive having a skin-adhesion surface that lies in a different plane from that of said reservoir skin-facing drug transfer surface; and

c) a backing on the skin distal surface of the reservoir.

2. A device according to claim 1 wherein said polymeric carrier comprises an ethylene vinyl acetate copolymer having a vinyl acetate content of 40%.

3. A device according to claim 2 wherein the adhesive is a polyisobutylene adhesive.

4. A device according to claim 1 wherein the discontinuous pattern of adhesive covers about 12% of the surface area of said reservoir skin-facing surface.

5. A device according to claim 4 wherein said discontinuous pattern comprises 1-8 parallel, longitudinal stripes of adhesive separated a predetermined distance from each other.

6. A device according to claim 5 wherein said pattern comprises 5 stripes of adhesive and said predetermined distance is about 1.27 cm.

7. A flexible and compliant device for the transdermal administration of testosterone at a therapeutically effective rate through intact scrotal skin comprising:

a) a reservoir comprising testosterone dispersed throughout a non-adhesive, polymeric carrier permeable to said testosterone, said reservoir having a skin-contacting surface and a skin-distal surface;

b) a discontinuous pattern of adhesive on the skin-contacting surface of the reservoir, said adhesive covering about 8-16% of the surface area of said reservoir skin-contacting surface, said pattern of adhesive having a skin-contacting surface that lies in a different plane from that of said reservoir skin-contacting surface; and

c) a backing on the skin distal surface of the reservoir.

8. A device according to claim 7 wherein said polymeric carrier comprises an ethylene vinyl acetate copolymer having a vinyl acetate content of 40%.

9. A device according to claim 8 wherein the adhesive is a polyisobutylene adhesive.

10. A device according to claim 7 wherein the discontinuous pattern of adhesive covers about 12% of the surface area of said reservoir skin-facing surface.

11. A device according to claim 10 wherein said discontinuous pattern comprises 1-8 parallel, longitudinal stripes of adhesive separated a predetermined distance from each other.

12. A device according to claim 11 wherein said pattern comprises 5 stripes of adhesive and said predetermined distance is about 1.27 cm.
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