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Last Updated: April 26, 2024

Claims for Patent: 6,348,210


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Summary for Patent: 6,348,210
Title: Methods for transdermal drug administration
Abstract:Adhesive transdermal drug delivery devices may be removed and subsequently reapplied to an area of skin if the adhesive has an initial adhesive/skin bond strength sufficient to maintain said transdermal drug delivery device on the skin to which it is applied for the entire predetermined administration period; and an adhesive/skin bond strength upon replacement on the skin after removal therefrom which is adequate to retain the device on the skin for the balance of the administration period.
Inventor(s): Gale; Robert Martin (Los Altos, CA)
Assignee: Alza Corporation (Mountain View, CA)
Application Number:09/438,574
Patent Claims: 1. A method for transdermal administration of a drug through non-scrotal skin over a predetermined administration period comprising:

a) placing a transdermal drug delivery device containing the drug and having an adhesive surface for maintaining the device on non-scrotal skin of an individual;

b) removing said device from the skin prior to the expiration of said period; and

c) reapplying said device on the non-scrotal skin of the individual;

d) wherein said adhesive surface is formed from an adhesive formulation that provides (i) an initial adhesive/skin bond strength sufficient to maintain said transdermal drug delivery device on the non-scrotal skin to which it is applied for the entire predetermined administration period and (ii) an adhesive/skin bond strength upon replacement on non-scrotal skin sufficient to retain said device for the balance of said administration period.

2. The method of claim 1 wherein said initial bond strength is less than 195 gm/cm.

3. The method of claim 2 wherein the initial bond strength is at least about 95 gm/cm.

4. The method of claim 2 wherein said adhesive formulation is a non-cross-linked adhesive formulation.

5. The method of claim 4 wherein the non-cross-linked adhesive polymer is polyisobutylene (PIB).

6. The method according to claim 1 wherein the adhesive surface comprises a mixture of low molecular weight polyisobutylene (LMW PIB) and high molecular weight polyisobutylene (HMW PIB).

7. A method according to claim 6 wherein the low molecular weight polyisobutylene (LMW PIB) has a molecular weight of about 15,000-50,000 and the high molecular weight polyisobutylene (HMW PIB) has a molecular weight of about 990,000-1,6000,000.

8. A method according to claim 7 wherein the adhesive further comprises a plasticizer.

9. A method according to claim 8 wherein high molecular weight polyisobutylene (HMW PIB)/low molecular weight polyisobutylene (LMW PIB)/plasticizer ratio is: 0.75-1.25/1-1.5/1.5-2.5.

10. The method of claim 2 wherein the adhesive/skin bond strength on replacement is at least 72% of said initial bond strength.

11. The method of claim 10 when the adhesive/skin bond strength on replacement is at least 85% of said initial bond strength.

12. The method of claim 3 wherein said adhesive/skin bond strength on replacement is at least 72% of said initial bond strength.

13. The method of claim 12 wherein the adhesive/skin bond strength on replacement is at least 85% of said initial bond strength.

14. The method of claim 9 wherein the plasticizer is selected from the group consisting of mineral oil and polybutene.

15. The method of claim 1 wherein said drug is testosterone.

16. The method of claim 3 wherein said drug is testosterone.

17. The method of claim 13 wherein said drug is testosterone.

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