Ocular implant made by a double extrusion process

• US 8,034,366 B2
• Filed: 10/31/2007
• Issued: 10/11/2011
• Est. Priority Date: 01/09/2003
• Status: Expired due to Fees

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Nivaggioli, Thierry, Shiah, Jane-Guo, Blanda, Wendy M., Weber, David A., Peng, Lin, Bhagat, Rahul, Chou, David
• Primary Examiner(s): Foley; Shanon A
• Application Number:
  US11/932,101
• Publication Number:
  US 20080286334A1
• Time in Patent Office: 1,441 Days
• Field of Search: None
• US Class Current: 424/426
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61K 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• 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 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• 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

Abstract

The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.

Claims

1. A bioerodible implant for treating a medical condition of the eye comprising a continuous, double extruded rod including an active agent homogeneously dispersed within a biodegradable polymer matrix, wherein the biodegradable polymer matrix comprises a mixture of PLGA having hydrophilic end groups and PLGA having hydrophobic end groups, and wherein the bioerodible implant is sized for implantation in an ocular region.

2. The bioerodible implant of claim 1 wherein the active agent is selected from the group consisting of ace-inhibitors, endogenous cytokines, agents that influence basement membrane, agents that influence the growth of endothelial cells, adrenergic agonists or blockers, cholinergic agonists or blockers, aldose reductase inhibitors, analgesics, anesthetics, antiallergics, anti-inflammatory agents, antihypertensives, pressors, antibacterials, antivirals, antifungals, antiprotozoals, anti-infective agents, antitumor agents, antimetabolites, and antiangiogenic agents.

3. The bioerodible implant of claim 1 wherein the active agent comprises an anti-inflammatory agent or any derivative thereof.

4. The bioerodible implant of claim 3 wherein the active agent comprises a steroidal anti-inflammatory agent or any derivative thereof.

5. The bioerodible implant of claim 4 wherein the active agent is selected from the group consisting of cortisone, dexamethasone, fluocinolone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone, and any derivative thereof.

6. The bioerodible implant of claim 5 wherein the active agent comprises dexamethasone.

7. The bioerodible implant of claim 6 wherein said hydrophilic end group is carboxyl, hydroxyl, polyethylene glycol, or a combination thereof.

8. A method for treating a medical condition of the eye in a subject comprising implanting into an ocular region of the subject the bioerodible implant of claim 1 and delivering a therapeutic amount of an active agent to the ocular region.

9. A bioerodible implant for treating a medical condition of the eye comprising a continuous, double extruded rod including dexamethasone homogeneously dispersed within a PLGA polymer matrix, wherein the bioerodible implant comprises approximately 60% by weight dexamethasone, approximately 30% by weight PLGA polymers having end groups consisting of —

COOH, and approximately 10% by weight PLGA polymers having end groups consisting of the formula —

COOR wherein R=alkyl, and wherein the bioerodible implant is sized for implantation in an ocular region.