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Claims for Patent: 5,508,038

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Claims for Patent: 5,508,038

Title: Polyisobutylene adhesives for transdermal devices
Abstract:An in-line adhesive, useful for transdermal delivery devices comprising a mixture of high and low molecular weighted polyisobutylene having a ratio HMW PIB:LMW PIB in the range of about 5-40:95-60 which is substantially free of plasticizers and tackifiers is disclosed. The adhesive finds particular use as a component of a transdermal delivery device for delivering oily non-polar agents such as nicotine, benztropine, secoverine, dexsecoverine, and arecoline.
Inventor(s): Wang; Karly S. (Newark, CA), Osborne; James L. (Mountain View, CA), Hunt; James A. (Fremont, CA), Nelson; Melinda K. (Sunnyvale, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:07/509,644
Patent Claims: 1. A polyisobutylene (PIB) adhesive composition for use in a transdermal active agent delivery device, said adhesive composition comprising an oily, non-polar liquid active agent dissolved in a polymeric component consisting essentially of a mixture of high molecular weight (HMW) PIB having an average molecular weight in the range of about 450,000-about 1,600,000 and low molecular weight (LMW) PIB having an average molecular weight in the range of about 1,000-about 450,000, the ratio HMW PIB:LMW PIB being in the range of 5-40:95-60; said adhesive composition being substantially free of plasticizers and tackifiers.

2. A polyisobutylene adhesive composition for use in a transdermal nicotine delivery device, said adhesive composition comprising nicotine dissolved in a polymeric component consisting essentially of a mixture of HMW PIB having an average molecular weight in the range of about 450,000-about 1,600,000 and LMW PIB having an average molecular weight in the range of about 1,000-about 450,000, the ratio HMW PIB:LMW PIB being in the range of 5-40:95-60; said adhesive composition being substantially free of plasticizers and tackifiers.

3. The composition of claim 1 or 2, wherein said HMW PIB has an average molecular weight in the range of about 990,000-about 1,600,000 and said LMW PIB has an average molecular weight in the range of about 35,000-about 50,000.

4. The composition of claim 3, wherein the ratio of HMW PIB:LMW PIB is in the range of 10-25:90-75.

5. The composition of claim 4, wherein the HMW PIB has an average molecular weight of about 1,200,000 and said LMW PIB has an average molecular weight of about 35,000.

6. The composition of claim 1 or 2 wherein said ratio is in the range of 10-20:90-80.

7. The composition of claim 3 wherein said ratio is in the range of 10-20:90-80.

8. The composition of claim 5 wherein said ratio is in the range of 10-20:90-80.

9. A transdermal delivery device for delivering an oily, non-polar active agent comprising:

a) reservoir means containing said active agent;

b) an in-line adhesive comprising:

(i) a polymeric component consisting essentially of a mixture of high molecular weight (HMW) PIB having an average molecular weight in the range of about 450,000-about 1,600,000 and low molecular weight (LMW) PIB having an average molecular weight in the range of about 1,000-about 450,000, the ratio HMW PIB:LMW PIB being in the range of 5-40:95-60; and

(ii) said active agent;

said adhesive being substantially free of plasticizers and tackifiers; and

c) active agent release rate controlling means disposed between said reservoir means and said in-line adhesive.

10. A transdermal nicotine delivery device comprising:

a) reservoir means containing nicotine as active agent;

b) an in-line adhesive comprising:

(i) a polymeric component consisting essentially of a mixture of HMW PIB having an average molecular weight in the range of about 450,000-about 1,600,000 and LMW PIB having an average molecular weight in the range of about 1,000-about 450,000, the ratio HMW PIB:LMW PIB being in the range of 5-40:95-60; and

(ii) nicotine;

said adhesive being substantially free of plasticizers and tackifiers; and

c) nicotine release rate-controlling means disposed between said reservoir means and said in-line adhesive.

11. The device of claim 9, wherein said active agent is selected from the group consisting of nicotine, benztropine, secoverine, dexsecoverine and arecoline.

12. The device of claim 9, 10 or 11 wherein said adhesive contains no more than about 50% of said active agent in the device.

13. A device for the transdermal administration of nicotine as an active agent, said device comprising:

a) a subsaturated nicotine reservoir containing up to about 40 wt % nicotine; and

b) an adhesive disposed in the path of nicotine migration from said nicotine reservoir to the skin, said adhesive comprising nicotine dissolved in a polymeric component consisting essentially of HMW PIB having an average molecular weight in the range of about 450,000-about 1,600,000 and LMW PIB having an average molecular weight in the range of about 1,000-about 450,000, the ratio of HMW PIB:LMW PIB being in the range of about 5-40:95-60, said adhesive being substantially free of plasticizers and tackifiers.

14. The device of claim 9, 10 or 13 wherein said ratio is in the range of 10-25:90-75.

15. The device of claim 9, 10 or 13 wherein said ratio is in the range of 10-20:90-80.

16. A device according to claim 10, wherein said nicotine release rate-controlling means is high density polyethylene.

17. A device according to claim 15, wherein said active agent reservoir comprises from about 5-40 wt % said active agent.

18. A device according to claim 10, wherein said nicotine reservoir comprises from about 60-95 wt % ethylene vinyl acetate copolymer having a vinyl acetate content of about 40%.

19. A device according to claim 15, wherein said adhesive contains no more than about 15 wt % said active agent.

20. The device of claims 9, 10, 11, 13, 16, or 18 wherein said HMW PIB has an average molecular weight of about 1,200,000 and said LMW PIB has an average molecular weight of about 35,000.
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