Sustained release intraocular implants and related methods

• US 8,263,110 B2
• Filed: 02/14/2008
• Issued: 09/11/2012
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Nivaggioli, Thierry, Huang, Glenn T
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US12/031,656
• Publication Number:
  US 20080131486A1
• Time in Patent Office: 1,671 Days
• Field of Search: None
• US Class Current: 424/428
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/14 Decongestants or antiallergics

Abstract

Biocompatible intraocular implants include a steroid and a polymer associated with each other to facilitate release of the steroid into an eye for a period of time greater than about two months. The steroid may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the steroid may be associated with a polymeric coating having one or more openings effective to permit the steroid to be released into an external environment. The implants may be placed in an eye to treat one or more ocular conditions. The steroid is released from the implant for more than about two months, and may be release for more than several years.

Claims

1. A method of making a biodegradable intraocular implant, comprising the step of:

extruding a mixture of a steroid and a biodegradable polymer to form a biodegradable material that releases drug at a rate effective to sustain release of a therapeutically effective amount of the steroid from the implant for a time greater than about two months from a time in which the implant is placed in an ocular site or region of an eye, wherein the biodegradable polymer comprises a mixture of first and second biodegradable polymers, wherein the first biodegradable polymer is a poly(D,L-lactide-co-glycolide) having terminal acid groups and an inherent viscosity of about 0.16 dl/g to about 0.24 dl/g, and the second biodegradable polymer is a poly(D L-lactide) having terminal acid groups and an inherent viscosity of about 0.16 dl/g to about 0.24 dl/g.

2. The method of claim 1, wherein the steroid is a corticosteroid.

3. The method of claim 1, wherein the steroid is a fluocinolone or a triamcinolone.

4. The method of claim 1, further comprising a step of mixing the steroid with the first and second polymers before the extrusion step.

5. The method of claim 1, wherein the steroid and the first and second polymers are in a powder form.

6. A method of making an intraocular implant, comprising the steps of:

forming a polymeric coating over a core comprising a steroid; and

forming a plurality of holes in the coating, the holes being sized to permit a liquid to pass therethrough, and to permit the steroid to pass from the implant to an external environment at a rate of less than 2 μ

g/day for a period of time at least about 2 months after the implant is placed in an eye of a patient.

7. The method of claim 6, wherein the holes are formed to permit the steroid to pass from the implant at a rate of about 0.5 μ

g/day.