Biodegradable non-opthalmic implants and related methods

• US 20070178138A1
• Filed: 02/01/2006
• Published: 08/02/2007
• Est. Priority Date: 02/01/2006
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Pal, Steven, Brin, Mitchell
• Application Number:
  US11/345,178
• Publication Number:
  US 20070178138A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61K 31/498 Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• 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: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/0087 Galenical forms not covered by A61K9/02 - A61K9/7023
• CPC Class Codes: A61K 9/146 with organic macromolecular compounds
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

Biodegradable non-ophthalmic implants include one or more agents dispersed within a biodegradable polymer component. The implants release the agents from the biodegradable polymer component to a target site of a patient as the implant degrades. The agents provided in the implants can be therapeutic agents or diagnostic agents and are useful in medical treatments of non-ocular regions of a patient.

Claims

1. A biodegradable non-ophthalmic implant, comprising:

a multi-extruded body member comprising a poly (lactide-co-glycolide) (PLGA) copolymer and a medically useful agent distributed throughout the PLGA copolymer in the form of a non-ophthalmic implant and releasable therefrom to a non-ophthalmic target site of a patient, the PLGA copolymer comprising about 75% by weight acid end PLGA and about 25% by weight ester end PLGA, and comprising about 50% lactide and about 50% glycolide.

2. The implant of claim 1, wherein the body member is a double extruded body member of the PLGA copolymer and the medically useful agent.

3. The implant of claim 1, wherein the medically useful agent is selected from the group of therapeutic agents and diagnostic agents.

4. The implant of claim 1, wherein the medically useful agent is a therapeutic agent homogenously distributed in a PLGA copolymer matrix and is releasable therefrom to provide a therapeutic effect at a non-ophthalmic target site that persists for a time beyond which the therapeutic agent is detectable at the target site.

5. The implant of claim 1, wherein the medically useful agent is selected from the group consisting of chemotherapeutic agents, anti-inflammatory agents, analgesic agents, anti-spasmodic agents, neuroprotective agents, and combinations thereof.

6. The implant of claim 5, wherein the medically useful agent is an anti-inflammatory agent selected from the group consisting of steroids and non-steroidal anti-inflammatory drug.

7. The implant of claim 5, wherein the medically useful agent is an alpha 2 adrenergic receptor agonist.

8. The implant of claim 7, wherein the medically useful agent is selected from the group consisting of brimonidine, salts thereof, and combinations thereof.

9. The implant of claim 1 provided in an implant injecting device.

10. The implant of claim 9, wherein the injecting device comprises a fiber optic system.

11. The implant of claim 1, wherein the body member is a neural implant.

12. The implant of claim 11, wherein the body member is an implant selected from the group consisting of intrathecal implants, intracranial implants, and intraspinal implants.

13. The implant of claim 1, wherein the body member is a cardiac implant.

14. The implant of claim 1, wherein the body member is a joint implant.

15. The implant of claim 1, wherein the body member is selected from the group consisting of pancreatic implants, kidney implants, liver implants, prostate implants, and breast implants.

16. The implant of claim 15, wherein the medically useful agent is a chemotherapeutic agent.

17. The implant of claim 1, wherein the medically useful agent is a therapeutic agent, and the implant releases the therapeutic agent with at least one of reduced side effects, enhanced dosing precision, and reduced frequency of administration relative to systemic administration of an identical therapeutic agent.

18. A method of treating a patient, comprising:

administering a biodegradable non-ophthalmic implant comprising a poly (lactide-co-glycolide) (PLGA) copolymer and a medically useful agent distributed throughout the PLGA copolymer in the form of a non-ophthalmic implant to a non-ophthalmic target site of a patient, the PLGA copolymer comprising about 75% by weight acid end PLGA and about 25% by weight ester end PLGA, and comprising about 50% lactide and about 50% glycolide, wherein the implant releases the medically useful agent to the target site for extended periods of time.

19. The method of claim 18, wherein the implant is administered to a cancerous target site.

20. The method of claim 19, wherein the implant is administered to an organ selected from the group consisting of the brain, the pancreas, the kidneys, the liver, the prostate gland, and the breasts to treat localized cancer tumors or pre-cancerous tissue of the organ.

21. The method of claim 18, wherein the implant is administered to a joint selected from the group consisting of arthritic joints and injured joints to relieve joint pain, joint inflammation, or joint disease.

22. The method of claim 18, wherein the implant is administered to a cardiac target site selected from the group consisting of heart muscle and cardiac arteries to enhance cardiac or vascular function in a patient in need thereof.

23. The method of claim 18, wherein the implant is administered to a target site in the central nervous system of the patient.

24. The method of claim 23, wherein the implant is administered into the spine of the patient, and the implant releases an analgesic or antispasmodic agent to provide long lasting pain or spasticity relief, respectively.

25. The method of claim 18, wherein the medically useful agent is an alpha 2 adrenergic agonist, and the implant is administered intrathecally to provide extended release of low doses of the alpha 2 adrenergic agonist and provide enhanced brain function.

26. The method of claim 18, wherein the implant comprises a steroid and the implant is administered to a central nervous system target site, and the method further comprises administering an implant comprising a chemotherapeutic agent into a different target site to treat a cancerous tumor of the different target site.

27. The method of claim 18, wherein the implant is injected into a target site using an implant injection device.