Solvent cast film sustained release latanoprost implant

• US 9,161,929 B2
• Filed: 03/20/2014
• Issued: 10/20/2015
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Ghebremeskel, Alazar N., Spada, Lon T.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Singh, Randeep
• Application Number:
  US14/220,945
• Publication Number:
  US 20140205649A1
• Time in Patent Office: 579 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• 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 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

Abstract

The present invention provides a sustained release latanoprost implant in the form of a thin film comprising latanoprost incorporated in a biodegradable polymer matrix. Preferably, said implant is an intraocular implant comprising a thin film comprising latanoprost incorporated in a biodegradable polymer matrix wherein said implant is configured as a disc or a rolled film that can be inserted into the eye and unrolls to provide a film having a high surface area to volume ratio.

Claims

1. A method of treating open-angle glaucoma or ocular hypertension comprising

(1) inserting into an eye of a patient in need of such treatment a rolled biodegradable film, wherein the film is rolled into a cylindrical shape, and wherein the insertion of the film is performed using a needle and syringe;

(2) allowing the rolled film, once inserted into the eye, to unfurl to its original shape to thereby expose its entire surface to provide for drug diffusion out of the film and into the eye;

thereby lowering the intraocular pressure of the eye;

wherein the film consists of about 30% by weight latanoprost, about 35% by weight R208, which is an ester terminated poly(D,L-lactide) having an inherent viscosity of about 1.8-2.2 dl/g, and about 35% by weight RG755, which is an ester terminated poly(D,L-lactide-co-glycolide) having an inherent viscosity of about 0.50-0.70 dl/g and a D,L-lactide;

glycolide ratio of about 75;

25.

2. The method of claim 1, wherein the film releases latanoprost continuously for at least 30 days after insertion in the eye of the patient.

3. The method of claim 1, wherein the original shape of the film is circular.

4. The method of claim 1, wherein the film is about 100 micron to about 500 micron thick and about 2 mm to 6 mm in diameter.

5. A method of treating open-angle glaucoma or ocular hypertension comprising

(1) inserting into an eye of a patient in need of such treatment a rolled biodegradable film, wherein the film is rolled into a cylindrical shape, and wherein the insertion of the film is performed using a needle and syringe;

(2) allowing the rolled film, once inserted into the eye, to unfurl to its original shape to thereby expose its entire surface to provide for drug diffusion out of the film and into the eye;

thereby lowering the intraocular pressure of the eye;

wherein the film consists of about 30% by weight latanoprost, about 35% by weight R208, which is an ester terminated poly(D,L-lactide) having an inherent viscosity of about 1.8-2.2 dl/g, and about 35% by weight R203S, which is an ester terminated poly(D,L-lactide) having an inherent viscosity of about 0.25-0.35 dl/g.

6. The method of claim 5, wherein the implant releases latanoprost continuously for at least 30 days after insertion in the eye of the patient.

7. The method of claim 5, wherein the original shape of the film is circular.