Method and composition for treating ocular hypertension and glaucoma

• US 9,999,593 B2
• Filed: 05/28/2009
• Issued: 06/19/2018
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: AGC, Inc., Santen Pharmaceutical Company Limited
• Original Assignee: Asahi Glass Company, Limited (AGC, Inc.), Santen Pharmaceutical Company Limited
• Inventors: Reunamaki, Timo, Pellinen, Pertti, Oksala, Olli, Lehmussaari, Kari
• Primary Examiner(s): Huang, Gigi
• Application Number:
  US12/995,351
• Publication Number:
  US 20110152264A1
• Time in Patent Office: 3,309 Days
• Field of Search: None
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates to an ophthalmic aqueous composition containing PGF2α analogs for treating ocular hypertension and glaucoma, to a method for treating ocular hypertension and glaucoma by administering said composition to a subject in need of such treatment, and to a method for increasing aqueous solubility and stability of PGF2α analogs in an aqueous composition.

Claims

1. An aqueous ophthalmic solution consisting of:

0.0015% w/v tafluprost;

0.075% w/v polysorbate 80;

0.05% w/v disodium edetate;

2.25% w/v glycerol;

0.2% w/v sodium dihydrogen phosphate dihydrate;

pH adjusters; and

water

wherein the solution is filled in a unit dose container and wherein the container is a low density polyethylene container which contains no more than 10% of any material other than polyethylene.

2. The aqueous ophthalmic solution according to claim 1, wherein the container is filled with 0.3 mL of the aqueous ophthalmic solution.

3. The aqueous ophthalmic solution according to claim 1, wherein the container is manufactured by extrusion blow moulding method.

4. The aqueous ophthalmic solution according to claim 1, wherein an amount of the aqueous ophthalmic solution in the container falls within a range of from 0.2 to 0.5 mL.

5. The aqueous ophthalmic solution according to claim 1, wherein less than 10% of said tafluprost is absorbed when the aqueous solution is stored at 40 degree Celsius for four weeks in the container.

6. The aqueous ophthalmic solution according to claim 1, wherein the container contains no material other than polyethylene.

7. The aqueous ophthalmic solution according to claim 6, wherein the material other than polyethylene is selected from the group consisting of polypropylene, polyethylene terephthalate, polyvinyl chloride, acrylic resins, polystyrene, polymethyl methacrylate and nylon 6.