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Details for Patent: 8,535,701

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Details for Patent: 8,535,701

Title:Sustained delivery of an active agent using an implantable system
Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.
Inventor(s): Peery; John R. (Stanford, CA), Dionne; Keith E. (Belmont, MA), Landrau; Felix A. (Punta Gorda, FL), Eckenhoff; James B. (Los Altos, CA), Lautenbach; Scott D. (San Mateo, CA), Magruder; Judy A. (Mountain View, CA), Wright; Jeremy C. (Los Altos, CA)
Assignee: Intarcia Therapeutics, Inc. (Hayward, CA)
Filing Date:Oct 04, 2012
Application Number:13/645,124
Claims:1. An implantable, fluid-imbibing device for delivering an active agent to a fluid environment of use, said device comprising the following components: an impermeable reservoir comprising an interior surface; a piston that divides the reservoir into a water-swellable agent chamber and an active agent formulation chamber, wherein the water-swellable agent chamber has an open end and the active agent formulation chamber has an open end; the active agent formulation chamber comprising an active agent formulation comprising the active agent; the water-swellable agent chamber comprising a water-swellable agent; a back diffusion regulating outlet received in the open end of the active agent formulation chamber of the reservoir for delivering fluid from the active agent formulation chamber to the fluid environment, the reservoir interior surface and back diffusion regulating outlet having surfaces in a mating relationship; and a water-swellable semipermeable plug received in sealing relationship with the interior surface of the open end of the water-swellable agent chamber of the reservoir, wherein the semipermeable plug imbibes between about 0.1% and about 200% by weight of water.

2. The implantable, fluid-imbibing device of claim 1, wherein the semipermeable plug has an aspect ratio of between 1:10 and 10:1 length to diameter.

3. The implantable, fluid-imbibing device of claim 2, wherein the semipermeable plug has an aspect ratio of between 7:10 and 2:1 length to diameter.

4. The implantable, fluid-imbibing device of claim 2, wherein the semipermeable plug has an aspect ratio of about 1:2 length to diameter.

5. The implantable, fluid-imbibing device of claim 1, wherein the reservoir interior surface and back diffusion regulating outlet have surfaces in the mating relationship, a helical flow path for the active agent formulation is formed between the surfaces in the mating relationship, a length of the helical flow path is sufficient to prevent back-diffusion of external fluid through the helical flow path, and the helical flow path has a length of about 2 to about 7 cm.

6. The implantable, fluid-imbibing device of claim 1, wherein the reservoir interior surface and back diffusion regulating outlet have surfaces in the mating relationship, a helical flow path for the active agent formulation is formed between the surfaces in the mating relationship, a length of the helical flow path is sufficient to prevent back-diffusion of external fluid through the helical flow path, and the helical flow path has a diameter of about 0.001 to about 0.020 inches.

7. The implantable, fluid-imbibing device of claim 1, wherein the semipermeable plug comprises a material selected from the group consisting of plasticized cellulosic materials, polyurethanes, hydroxyethylmethacrylate, polyether-polyamide copolymers, and polyamides.

8. The implantable, fluid-imbibing device of claim 1, wherein the water-swellable agent comprises two tablets comprising sodium chloride.

9. The implantable, fluid-imbibing device of claim 8, wherein the water-swellable agent chamber further comprises an additive to exclude air from spaces around the water-swellable agent.

10. The implantable, fluid-imbibing device of claim 9, wherein the additive is polyethylene glycol.

11. The implantable, fluid-imbibing device of claim 1, wherein the reservoir comprises a material selected from the group consisting of a non-reactive polymer, a biocompatible metal, and a biocompatible metal alloy.

12. The implantable, fluid-imbibing device of claim 11, wherein the reservoir comprises a non-reactive polymer selected from the group consisting of acrylonitrile polymers and halogenated polymers.

13. The implantable, fluid-imbibing device of claim 11, wherein the reservoir comprises a non-reactive polymer selected from the group consisting of acrylonitrile-butadiene-styrene terpolymers; polytetrafluoroethylenes; polychlorotrifluoroethylenes; copolymer tetrafluoroethylenes; hexafluoropropylenes; polyimides; polysulfones; polycarbonates; polyethylenes; polypropylenes; polyvinylchloride-acrylic copolymers; polycarbonate-acrylonitrile-butadiene-styrenes; and polystyrenes.

14. The implantable, fluid-imbibing device of claim 11, wherein the reservoir comprises a biocompatible metal or a biocompatible metal alloy selected from the group consisting of stainless steel, titanium, platinum, tantalum, gold, stainless steel alloys, titanium alloys, platinum alloys, tantalum alloys, gold alloys, gold-plated ferrous alloys, platinum-plated ferrous alloys, cobalt-chromium alloys, and titanium nitride coated stainless steel.

15. The implantable, fluid-imbibing device of claim 14, wherein the reservoir comprises titanium or a titanium alloy.

16. The implantable, fluid-imbibing device of claim 15, wherein the reservoir comprises greater than 60% titanium or the titanium alloy.

17. The implantable, fluid-imbibing device of claim 16, wherein the reservoir comprises greater than 85% titanium or the titanium alloy.

18. The implantable, fluid-imbibing device of claim 1, wherein the piston comprises an elastomeric material.

19. The implantable, fluid-imbibing device of claim 1, wherein the piston comprises a material selected from the group consisting of polypropylene, EPDM, silicone rubber, butyl rubber, plasticized polyvinylchloride, and polyurethanes.

20. The implantable, fluid-imbibing device of claim 1, wherein the back diffusion regulating outlet is made of an insert, biocompatible material.

21. The implantable, fluid-imbibing device of claim 20, wherein the inert, biocompatible material of the back diffusion regulating outlet comprises a polymer.

22. The implantable, fluid-imbibing device of claim 21, wherein the inert, biocompatible material of the back diffusion regulating outlet comprises a polymer selected from the group consisting of polyethylene, polypropylene, polycarbonate and polymethylmethacrylate.

23. The implantable, fluid-imbibing device of claim 20, wherein the inert, biocompatible material of the back diffusion regulating outlet comprises a metal.

24. The implantable, fluid-imbibing device of claim 1, wherein the active agent is selected from the group consisting of a peptide and a protein.

25. The implantable, fluid-imbibing device of claim 1, wherein one or more component is sterilized.

26. The implantable, fluid-imbibing device of claim 25, wherein the one or more component is sterilized using a method selected from the group consisting of gamma radiation, steam sterilization, and sterile filtration.
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