Method and composition for treating ocular hypertension and glaucoma
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.
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.