Zero-order prolonged release coaxial implants

• US 8,889,174 B1
• Filed: 08/20/2012
• Issued: 11/18/2014
• Est. Priority Date: 06/22/2001
• Status: Active Grant

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Gibson, John W., Tipton, Arthur J., Holl, Richard, Meador, Stacey
• Primary Examiner(s): Azpuru, Carlos
• Assistant Examiner(s): HAGOPIAN, CASEY SHEA
• Application Number:
  US13/589,847
• Time in Patent Office: 820 Days
• Field of Search: None
• US Class Current: 424/426
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 9/0002 Galenical forms characterised by the drug release technique; Application systems commanded by energy
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 29/02 without antiinflammatory effect
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

A coaxial implant has been developed using biodegradable polymeric materials. The coaxial implant has a core containing drug, surrounded by a semi-permeable membrane that controls the rate of release of material from the core. The core containing the drug and the polymer membrane(s) can be the same or different polymer. The core acts as a reservoir of drug, which partitions from the core polymer to form a saturated solution of drug at the polymer membrane.

Claims

1. A polymeric implant comprising a narcotic analgesic or a narcotic antagonist and a rate-controlling membrane, wherein the membrane is porous and has a pore volume ranging from about 5% to about 70%, wherein the implant comprises a rod, wherein the implant is a coaxial implant comprising a core containing the analgesic or antagonist and the rate controlling membrane, and wherein the analgesic or antagonist is released over a period of at least thirty days with zero order or near zero order release kinetics.

2. The implant of claim 1 wherein the analgesic or antagonist is selected from the group consisting of sufentanil, fentanyl, naltrexone, and naloxone.

3. The implant of claim 1 wherein the polymer is biodegradable.

4. The implant of claim 1 wherein the implant is a device selected from the group consisting of a matrix, prosthetic, graft, or coating.

5. The implant of claim 4 wherein the device is suitable for implantation intravascularly.

6. The implant of claim 5 wherein the device further comprises an active agent selected from the group consisting of heparin, taxol and other drugs for use in treating or preventing restenosis.

7. The implant of claim 4 suitable for implantation into a body lumen.

8. The implant of claim 4 suitable for implantation adjacent to a nerve plexus.

9. The implant of claim 1 wherein the core composition further comprises concentric layers having different compositions.

10. The implant of claim 1 wherein the core further comprises an excipient.

11. The implant of claim 1 wherein the rate-controlling membrane comprises pore forming agents.

12. The implant of claim 1 wherein the implant comprises a polymer selected from the group consisting of polyethylene glycol, polyhydroxyacid, caprolactone, or copolymer thereof.

13. The implant of claim 1 wherein the implant has sealed ends.

14. The implant of claim 1 wherein the implant is further processed by post-extrusion drawing or annealing.

15. A method of administering an analgesic or a narcotic antagonist thereof to a patient in need thereof comprising implanting the implant of claim 1 in the patient.

16. The implant of claim 1, wherein the rate-controlling membrane comprises pores ranging from about 1 micron to about 30 microns.

17. The implant of claim 1, wherein the rate controlling membrane comprises a polymer selected from the group consisting of polyhydroxyacids, polyanhydrides, polyorthoesters, polyetheresters, polyethylene glycol, polycaprolactone, polyesteramides, polyphosphazenes, polycarbonates, and copolymers and blends thereof.