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Claims for Patent: 6,375,978

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Claims for Patent: 6,375,978

Title: Rate controlling membranes for controlled drug delivery devices
Abstract:This invention provides rate controlling membranes for controlled drug delivery devices that are stable over time and exhibit more predictable and consistent membrane functionality. According to another aspect, the membranes have enhanced permeability. According to the invention, the rate controlling membrane of a controlled drug delivery device is subjected to a pre-treatment annealing process wherein it is subjected to an elevated temperature for a predetermined time period and subsequently cooled to ambient conditions before incorporation into a controlled drug delivery device.
Inventor(s): Kleiner; Lothar W. (Los Altos, CA), Gale; Robert M. (Los Altos, CA), Berggren; Randall G. (Livermore, CA), Tong; Gilbert T. (Union City, CA), Chen; Guohua (Sunnyvale, CA), Dionne; Keith E. (Cambridge, MA), Houston; Paul R. (Hayward, CA)
Assignee: ALZA Corporation (Mountain View, CA)
Application Number:09/213,213
Patent Claims: 1. A rate controlling membrane for a controlled drug delivery device characterized by being subjected to an elevated temperature of about 30.degree. C. to about 5.degree. C. below the melting temperature of the membrane polymer for a predetermined period of about 1-250 hours prior to combination with adnig containing component of said delivery device.

2. A rate controlling membrane according to claim 1 wherein the membrane material is selected from the group consisting of ethylene vinyl acetate copolymers, polyethylene, ethylene copolymers, ethylene oxide copolymers, polyamides, cellulosic materials, polyurethanes, polyether blocked amides copolymers, and polyvinyl acetate.

3. A rate controlling membrane according to claim 1 wherein the membrane comprises ethylene vinyl acetate copolymer.

4. A rate controlling membrane according to claim 3 wherein the vinyl acetate content is about 4-18%.

5. A rate controlling membrane according to claim 4 wherein the membrane is characterized by a DSC profile having a primary peak at about 94-99.degree. C. and a secondary peak at greater than about 50.degree. C.

6. A rate controlling membrane according to claim 5 wherein the vinyl acetate content is about 5-12%.

7. A rate controlling membrane according to claim 2 or 5 wherein the device is a transdermal drug delivery device comprising a drug reservoir layer between a backing layer and a contact adhesive layer, said rate controlling membrane is on the skin-proximal side of the drug reservoir layer.

8. A rate controlling membrane according to claim 7 wherein the drug reservoir comprises a drug selected from the group consisting of testosterone, estradiol, and fentanyl.

9. A rate controlling membrane according to claim 2 or 5 wherein the device is a transdermal drug delivery device comprising a backing layer, a permeation enhancer reservoir containing a permeation enhancer on the skin proximal side of the backing layer, a drug reservoir layer containing at least one drug to be transdermally administered on the skin proximal side of the permeation enhancer reservoir, and a means for maintaining said drug device in drug transmitting relation with the skin, wherein the rate controlling membrane is positioned between the permeation enhancer reservoir and the drug reservoir.

10. A rate controlling membrane according to claim 2 wherein the membrane comprises a material selected from the group consisting of polyurethanes or polyether blocked amides copolymers.

11. A rate controlling membrane according to claim 10 wherein the membrane is positioned in sealing relationship with an internal surface of one end of an impermeable reservoir of a fluid-imbibing drug delivery device, wherein said fluid imbibing drug delivery device comprises an impermeable reservoir containing a piston that divides the reservoir into a drug containing chamber and a water-swellable agent containing chamber, wherein the water-swellable agent containing chamber is provided with an outlet which accommodates said membrane.

12. A rate controlling membrane according to claim 11 wherein the drug containing chamber comprises leuprolide.

13. A rate controlling membrane according to claim 1 wherein the elevated temperature is about 45-80.degree. C. and the predetermined period is about 1-75 hours.

14. A rate controlling membrane according to claim 1 wherein the membrane is cooled to ambient conditions before being incorporated into the delivery device.

15. A rate controlling membrane according to claim 3 wherein the elevated temperature is about 52-72.degree. C. and the predetermined time is about 2-36 hours.

16. A rate controlling membrane according to claim 10 wherein the elevated temperature is about 55-75.degree. C. and the predetermined time is about 12-48 hours.

17. A method for processing rate controlling membranes used in controlled drug delivery devices comprising:

a) exposing the membrane to a predetermined temperature of from about 30.degree. C. to about 5.degree. C. below the melting temperature of the membrane polymer prior to combination with a drug containing component of said delivery device;

b) maintaining the membrane at the predetermined temperature for a period of time of from about 1 to 250 hours; and

c) incorporating said membrane into a controlled drug delivery device.

18. A method according to claim 17 wherein the predetermined temperature is from about 45.degree. C. to 80.degree. C.

19. A method according to claim 18 wherein the membrane is maintained at the predetermined temperature for a period of time of from about 1 to 75 hours.

20. A method according to claim 17 wherein the membrane is cooled to ambient conditions over a period of time of about 0.1-150 hours prior to incorporating the membrane into the device.

21. A method according to claim 17 wherein the membrane is incorporated into a transdermal drug delivery device and comprises an increased drug permeability compared to a non-annealed membrane of the same materials.

22. A method according to claim 17 wherein the membrane is formed from a material selected from the group consisting of ethylene vinyl acetate copolymers, polyethylene, ethylene copolymers, ethylene oxide copolymers, polyamides, cellulosic materials, polyurethanes, polyether blocked amides copolymers, and polyvinyl acetate.

23. A method according to claim 17 wherein the membrane is formed from ethylene vinyl acetate copolymer.

24. A method according to claim 23 wherein the membrane comprises 4-18% vinyl acetate.

25. A method according to claim 24 wherein the membrane comprises 5-12% vinyl acetate.

26. A method according to claim 24 wherein the predetermined temperature is about 52-72.degree. C. and the period of time is about 2-36 hours.

27. A method according to claim 17 wherein the membrane is formed from high density polyethylene.

28. A method according to claim 17 wherein the membrane is allowed to set at ambient conditions for a period of at least about 12 hours after processing prior to exposing the membrane to said predetermined temperature.

29. A method according to claim 28 wherein the membrane is allowed to set at ambient conditions for a period of at least 48 hours after processing prior to exposing the membrane to said predetermined temperature.

30. A method according to claim 17 wherein the membrane comprises polyurethane.

31. A method according to claim 30 wherein the predetermined temperature is about 55-75.degree. C. and the period of time is about 12-48 hours.

32. A method according to claim 31 wherein the membrane is positioned in sealing relationship with an internal surface of one end of an impermeable reservoir of a fluid-imbibing drug delivery device, wherein said fluid imbibing drug delivery device comprises an impermeable reservoir containing a piston that divides the reservoir into an active agent containing chamber and a water-swellable agent containing chamber, wherein the water-swellable agent containing chamber is provided with an outlet which accommodates said membrane.

33. A method according to claim 32 wherein the membrane is plug-shaped.

34. A rate controlling membrane for a controlled drug delivery device, wherein the membrane material consists of ethylene vinyl acetate copolymer having a vinyl acetate content of about 4-18%, and further wherein said membrane is characterized by a DSC profile having a primary peak at about 94-99.degree. C. and a secondary peak at greater than about 50.degree. C.

35. A rate controlling membrane for an osmotic pump of a fluid-imbibing drug delivery device characterized by being subjected to an elevated temperature of about 30.degree. C. to about 5.degree. C. below the melting temperature of the membrane polymer for a predetermined period of about 1-250 hours prior to combination with a drug containing component of said delivery device, wherein the membrane comprises a material selected from the group consisting of polyurethanes or polyether blocked amides copolymers, and further wherein fluid peimeability of said rate controlling membrane regulates imbibition of fluid into said osmotic pump.
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