Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
View Patent ↗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.
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 μm;
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 μm;
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.