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Claims for Patent: 8,211,880

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Claims for Patent: 8,211,880

Title:Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
Abstract: Triamcinolone acetonide suspension compositions are disclosed. The suspension compositions have a relatively low viscosity and are easy to extrude through a 27- or 30-guage needle but are highly flocculated and easily redispersed. The compositions are particularly suitable for intravitreal injection.
Inventor(s): Kabra; Bhagwati P. (Euless, TX), Sarkar; Ruma (Fort Worth, TX)
Assignee: Alcon Research, Ltd. (Fort Worth, TX)
Application Number:13/352,009
Patent Claims: 1. A method of treating an ophthalmic disorder comprising administering by intravitreal injection an aqueous suspension composition, wherein the suspension composition does not contain a preservative, has a pH from 6-7.5, a viscosity from 2-12 cps, and a Degree of Flocculation of 9.5 or greater, and wherein the suspension composition consists essentially of: a) 4% (w/v) triamcinolone acetonide having a mean volume diameter of 3-10 .mu.m; b) 0.5% (w/v) sodium carboxymethylcellulose; c) 0.002-0.015% (w/v) polysorbate 80; d) one or more pharmaceutically acceptable chloride salts selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, and magnesium chloride as tonicity-adjusting agents in a total amount sufficient to cause the suspension composition to have an osmolality from 250-350 mOsm; e) water for injection; f) a buffering agent; and g) optionally a pH-adjusting agent.

2. A method of enhancing visualization of the vitreous during vitrectomy procedures comprising administering by intravitreal injection an aqueous suspension composition, wherein the suspension composition does not contain a preservative, has a pH from 6-7.5, a viscosity from 2-12 cps, and a Degree of Flocculation of 9.5 or greater, and wherein the suspension composition consists essentially of: a) 4% (w/v) triamcinolone acetonide having a mean volume diameter of 3-10 .mu.m; b) 0.5% (w/v) sodium carboxymethylcellulose; c) 0.002-0.015% (w/v) polysorbate 80; d) one or more pharmaceutically acceptable chloride salts selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, and magnesium chloride as tonicity-adjusting agents in a total amount sufficient to cause the suspension composition to have an osmolality from 250-350 mOsm; e) water for injection; f) a buffering agent; and g) optionally a pH-adjusting agent.
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