FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions refers to pharmaceutical industry, namely to compositions and methods of treating ophthalmic disorders. Aqueous pharmaceutically stable ophthalmic composition for treating ptosis, comprising: a) 0.1 wt.% of oxymetazoline hydrochloride; b) from 0.2 to 1.0 wt.% of sodium chloride; c) from 0.05 to 0.10 wt.% of potassium chloride; d) from 0.02 to 0.06 wt.% of calcium chloride; e) from 0.01 to 0.05 wt.% of magnesium chloride; f) one or more suitable buffers; g) from 0.1 to 0.90 wt.% of hypromellose; and h) optionally a pH regulator; wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Aqueous pharmaceutically stable ophthalmic composition for increasing vertical separation of an upper eyelid and a lower eyelid in at least one eye in a subject, comprising said components in said amount, and wherein the composition is stable for a period of at least 24 months. Aqueous pharmaceutically stable ophthalmic composition for improving the upper part of the visual field in a subject, comprising the above substances in the above amount, wherein the composition has a pH in range of 5.8 to 6.8, and wherein the composition is stable for a period of at least 24 months. Disposable container containing any of the above compositions. Aqueous pharmaceutically stable ophthalmic composition for treating ptosis, consisting of said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Aqueous pharmaceutically stable ophthalmic composition for increasing vertical separation of an upper eyelid and a lower eyelid in at least one eye in a subject, consisting of said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Aqueous pharmaceutically stable ophthalmic composition for improving the upper part of the visual field in a subject, consisting of the above substances in the above amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Disposable container containing any of the above composition. Aqueous pharmaceutically stable ophthalmic preservative-free composition for treating ptosis, comprising said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Aqueous pharmaceutically stable ophthalmic preservative-free composition for increasing vertical separation of an upper eyelid and a lower eyelid in at least one eye in a subject, comprising said substances in a specified amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Method of treating ptosis in a subject, comprising administering into at least one eye of a subject a therapeutically effective amount of an aqueous pharmaceutically stable ophthalmic preservative-free composition comprising said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and wherein the composition is stable for a period of at least 24 months. Method for increasing vertical separation of upper eyelid and lower eyelid of at least one eye in a subject, comprising administering to at least one eye of a subject a therapeutically effective amount of an aqueous pharmaceutically stable ophthalmic preservative-free composition comprising said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and the composition is stable for a period of at least 24 months. Method for improving the Lester peripheral visual field test (LPFT) score in a subject, comprising administering to at least one eye of a subject a therapeutically effective amount of an aqueous pharmaceutically stable ophthalmic preservative-free composition comprising said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and wherein the composition is stable for a period of at least 24 months, and whereby the average LPFT score is increased by 5–10 points in 0.1–16 hours after administration. Method for improving the score of the marginal reflex distance 1 (MRD-1) test in a subject, comprising administering to at least one eye of a subject a therapeutically effective amount of an aqueous pharmaceutically stable ophthalmic preservative-free composition comprising said substances in said amount, wherein the composition has a pH in range of 5.8 to 6.8, and wherein the composition is stable for a period of at least 24 months and whereby the average score is increased by 0.2–1.5 points 1–20 minutes after administration or 0.1-16 hours after administration.
EFFECT: use of the group of inventions provides an ophthalmic composition stable for a period of at least 24 months, a disposable container for storing the composition, as well as effective treatment of ptosis, increased vertical separation of upper and lower eyelids, improved Lester peripheral visual field test (LPFT), improved marginal reflex distance test 1 (MRD-1).
52 cl, 5 dwg, 12 tbl, 6 ex
