Claims for Patent: 10,045,943

Summary for Patent: 10,045,943

Title:	Implantable medical devices for extended release of therapeutic agents
Abstract:	The invention pertains to implantable medical devices for controlled delivery of therapeutic agents. Some devices according to the invention have a titanium reservoir, and a porous titanium oxide based membrane to control the rate of release of the therapeutic agent. The reservoir contains a formulation of the active agent, including a stabilizer for the active agent, wherein the stabilizer is provided in an extended release configuration.
Inventor(s):	Roorda; Wouter Erik (Emeryville, CA)
Assignee:	Nano Precision Medical, Inc. (Emeryville, CA)
Application Number:	15/094,936
Patent Claims:	1. An implantable drug delivery system, said implantable drug delivery system comprising: a titanium capsule suitable for implantation; a reservoir encapsulated by the capsule, at least one nanoporous membrane in fluid contact with the reservoir, wherein the reservoir contains a pharmaceutical composition including a water soluble therapeutic agent with an equilibrium solubility at room temperature of more than 1.0.times.10.sup.-3M; and a stability enhancing agent, wherein the stability enhancing agent is a biodegradable polymer which generates an acidic molecule upon degradation. 2. The implantable drug delivery system of claim 1, wherein the therapeutic agent is a protein or peptide. 3. The implantable drug delivery system of claim 2, wherein the protein or peptide is selected from the group consisting of beta-glucocerobrosidase, interferon a, interferon beta, agasidase alpha, agasidase beta, exenatide, octreotide, LHRH, LHRH analog, calcitonin, nutropin/somatropin, factor VIII, aldesleukin, forigerimod, NP fusion proteins, IL-12, a melanocyte stimulating hormone, and bapineuzumab. 4. The implantable drug delivery system of claim 1, wherein the therapeutic agent is a member selected from the group consisting of exenatide and octreotide. 5. The implantable drug delivery system of claim 1, wherein the therapeutic agent is exenatide. 6. The implantable drug delivery system of claim 5, wherein the amount of exenatide is about 60 .mu.g to about 50 mg. 7. The implantable drug delivery system of claim 1, wherein the biodegradable polymer is a member selected from the group consisting of a poly-ester, a poly-amide, a poly-anhydride, a poly-saccharide, a poly-orthoester, a poly-lactone and a combination thereof. 8. The implantable drug delivery system of claim 7, wherein the biodegradable polymer is a member selected from the group consisting of a homo-polymer of lactic acid, a homo-polymer of glycolic acid and a co-polymer of lactic acid and glycolic acid. 9. The implantable drug delivery system of claim 8, wherein the biodegradable polymer is a co-polymer of lactic acid and glycolic acid. 10. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid is in a ratio of 99:1 to 1:99 of lactic acid to glycolic acid. 11. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid is in a ratio selected from the group of 85:15, 75:25, 65:35, 50:50 and 45:55. 12. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid has a molecular weight of about 4000 to about 50,000. 13. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid has a molecular weight of about 6000 to about 30,000. 14. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid has a molecular weight of about 7000 to about 20,000. 15. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid is in a weight ratio of 0.1-100:1 of the therapeutic agent. 16. The implantable drug delivery system of claim 9, wherein the co-polymer of lactic acid and glycolic acid is in a weight ratio of 0.1-10:1 of the therapeutic agent. 17. The implantable drug delivery system of claim 1, wherein the pharmaceutical composition is a member selected from the group consisting of a solid, a powder, a granule, and a microsphere. 18. A method for treating a disease in a subject in need thereof, the method comprising: administering to the subject a therapeutically effective amount of a water soluble therapeutic agent, which has an equilibrium solubility at room temperature of more than 1.0.times.10.sup.-3M contained within an implantable drug delivery system, the drug delivery system including: a titanium capsule suitable for implantation; a reservoir encapsulated by the capsule, at least one nanoporous membrane in fluid contact with the reservoir, wherein the reservoir contains a pharmaceutical composition comprising the therapeutic agent and a stability enhancing agent, wherein the stability enhancing agent is a biodegradable polymer which generates an acidic molecule upon degradation.

Details for Patent 10,045,943

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	06/23/1987		2034-11-02
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10/16/1986		2034-11-02
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	02/04/1999		2034-11-02