CARBONIC ANHYDRASE INHIBITOR SUSTAINED RELEASE INTRAOCULAR DRUG DELIVERY SYSTEMS

• US 20110034448A1
• Filed: 10/31/2007
• Published: 02/10/2011
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Devries, Gerald W., Chang, James N., Hughes, Patrick M.
• Granted Patent: US 8,591,885 B2
• Time in Patent Office: Days
• US Class Current: 514/226.5
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61K 48/0041 the non-active part being polymeric
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• 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 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Biocompatible intraocular drug delivery systems include a carbonic anhydrase inhibitor therapeutic agent and a polymeric component in the form of an implant, a microparticle, a plurality of implants or microparticles, and combinations thereof. The therapeutic agent is released in a biologically active form, for example, the therapeutic agent may retain its three dimensional structure when released into an eye of a patient, or the therapeutic agent may have an altered three. The implants may be placed in an eye to treat or reduce the occurrence of one or more ocular conditions, such as retinal damage, including glaucoma and proliferative vitreoretinopathy among others.

Claims

1. A sustained release intraocular drug delivery system comprising:

a therapeutic component which is a carbonic anhydrase inhibitor, and;

a polymeric component associated with the therapeutic component to permit the therapeutic component to be released into the interior of an eye of an individual at a therapeutically effective dosage for a period of time after the drug delivery system is placed in the eye.

2. The system of claim 1, wherein the polymeric component comprises a biodegradable polymer or biodegradable copolymer, the therapeutic component being associated with the polymeric component as a plurality of biodegradable particles.

3. The system of claim 1, wherein the polymeric component comprises a biodegradable polymer or biodegradable copolymer, the therapeutic component being associated with the polymeric component as a biodegradable implant.

4. The system of claim 1 wherein said system is formulated to release at least 10% of its active ingredient in the first two weeks following administration to the posterior chamber of a human eye.

5. The system of claim 1 wherein said system is formulated to release at least 20% of its active ingredient in the first two weeks following administration to the posterior chamber of a human eye.

6. The system of claim 1 wherein said system is formulated to release at least 30% of its active ingredient in the first two weeks following administration to the posterior chamber of a human eye.

7. The system of claim 1 wherein said system is formulated to release at least 40% of its active ingredient in the first two weeks following administration to the posterior chamber of a human eye.

8. The system of claim 1 in which said therapeutic component is present in a viscous aqueous medium.

9. The system of claim 11 wherein the polymeric component comprises hyaluronic acid.

10. The system of claim 1, wherein the polymeric component comprises a polymer selected from the group consisting of biodegradable polymers, non-biodegradable polymers, biodegradable copolymers, non-biodegradable copolymers, and combinations thereof.

11. The system of claim 1, wherein the polymeric component comprises a polymer selected from the group consisting of poly-lactic acid (PLA), poly-glycolic acid (PGA), poly-lactide-co-glycolide (PLGA), polyesters, poly (ortho ester), poly(phosphazine), poly (phosphate ester), polycaprolactones, gelatin, collagen, derivatives thereof, and combinations thereof.

12. The system of claim 1, wherein the therapeutic component and the polymeric component are associated in the form of an implant selected from the group consisting of solid implants, semisolid implants, and viscoelastic implants.

13. The system of claim 1, wherein the therapeutic component and the polymeric component are associated with each other so that the release of the therapeutic component into the eye is by a method selected from the group consisting of diffusion, erosion, dissolution, osmosis, and combinations thereof.

14. The system of claim 1, wherein the therapeutic component and the polymeric component are associated with each other so that the therapeutic component is released into the eye for a time period from about four weeks to about 16 weeks after the system is administered to the interior of the eye.

15. The system of claim 1, wherein the therapeutic component and the polymeric component are associated with each other so that the therapeutic component is released into the eye for a time period greater than one year after the system is placed in the interior of the eye.

16. The system of claim 1, further comprising an excipient component.

17. The system of claim 1, wherein the drug delivery system is in the form of an extruded composition.

18. The system of claim 1 wherein the system is structured to be placed in the vitreous of the eye.

19. The system of claim 1 wherein the system is structured to be placed subconjunctivally.

20. The system of claim 1 wherein the system is structured to be placed subretinally.

21. The system of claim 1 which is formed as at least one of a rod, a wafer, and a particle.

22. A composition comprising the system of claim 1 and a ophthalmically acceptable carrier component.

23. The method of claim 1, wherein the drug delivery system is a biodegradable implant placed into the interior of the eye that provides treatment of an ocular condition selected from the group consisting of uveitis, macular edema, macular degeneration, proliferative retinopathy, diabetic retinopathy, retinitis pigmentosa and glaucoma.