Ocular implant made by a double extrusion process

• US 8,318,070 B2
• Filed: 09/01/2011
• Issued: 11/27/2012
• Est. Priority Date: 01/09/2003
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Shiah, Jane-Guo, Bhagat, Rahul, Blanda, Wendy M., Nivaggioli, Thierry, Peng, Lin, Chou, David, Weber, David A.
• Primary Examiner(s): Foley, Shanon A
• Application Number:
  US13/224,041
• Publication Number:
  US 20110309546A1
• Time in Patent Office: 453 Days
• Field of Search: None
• US Class Current: 264/266
• 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 method for making an ocular bioerodible implant for treating a medical condition of the eye, the method comprising:

a) milling a hydrophilic ended poly(D,L-lactide-co-glycolide) (PLGA) polymer;

b) milling a hydrophobic ended poly(D,L-lactide-co-glycolide) (PLGA) polymer;

c) blending the milled polymers together with particles of dexamethasone to form a blended mixture comprising a hydrophilic ended PLGA, a hydrophobic ended PLGA, and dexamethasone, wherein at least about 75% of the particles of the dexamethasone have a diameter of less than about 20 μ

m;

d) performing a plurality of heat extrusions of the blended mixture, thereby forming a filament including a homogenous distribution of the dexamethasone, wherein the ocular bioerodible implant has a reduced in-batch variability relative to a single extrusion implant.

2. The method of claim 1, wherein the bioerodible implant is sized for implantation in the vitreous cavity.

3. The method of claim 2, wherein the dexamethasone constitutes from about 10% to about 90% by weight of the implant.

4. The method of claim 3, wherein the dexamethasone constitutes from about 40% to about 80% by weight of the implant.

5. The method of claim 4, wherein the dexamethasone constitutes about 60% by weight of the implant.