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US 12,178,874 B2Granted
Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
AssigneeJust-Evotec Biologics, Inc.
InventorsAlison J. Gillespie, Julee A. Floyd, Bruce A. Kerwin, Christine C. Siska
Life of this patent
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Abstract
Ophthalmic formulations comprising aflibercept and a lysine salt tonicifying agent are disclosed that are suitable for a method of treatment of an eye disorder or disease by intravitreal or topical administration.
Claims34
An ophthalmic formulation, comprising:
- (a) aflibercept in a concentration of 5-100 mg/ml;
- (b) a phosphate or acetate buffer at 5-50 mM concentration;
- (c) a non-ionic surfactant;
- and
- (d) a lysine salt as a tonicifying agent, in the range of 2-3% (w/v), wherein the ophthalmic formulation has a final osmolality of 300+50 mOsm/kg;
- wherein the pH of the ophthalmic formulation is about pH 5.0 to about pH 6.5.
3 more elements
An ophthalmic formulation, comprising:
- (a) aflibercept in a concentration of 20-80 mg/ml;
- (b) a phosphate or acetate buffer at 5-50 mM concentration;
- (c) a non-ionic surfactant selected from the group consisting of a polysorbate and a poloxamer;
- and
- (d) a lysine salt as a tonicifying agent, at a concentration of about 2-3% (w/v), wherein the ophthalmic formulation has a final osmolality of 300+50 mOsm/kg;
- wherein the pH of the ophthalmic formulation is about pH 5.0 to about pH 6.5.
3 more elements
An ophthalmic formulation, comprising:
- (a) aflibercept in a concentration of 5-100 mg/mL;
- (b) a phosphate buffer at 5-50 mM concentration;
- (c) a non-ionic surfactant selected from the group consisting of a polysorbate at about 0.001% (w/v) to about 0.1% (w/v) concentration and a poloxamer at about 0.01% (w/v) to about 1% (w/v) concentration;
- and
- (d) a lysine salt as a tonicifying agent, at a concentration of about 2-3% (w/v), wherein the ophthalmic formulation has a final osmolality of 300+50 mOsm/kg;
- wherein the pH of the ophthalmic formulation is about pH 6.0 to about pH 6.5.
3 more elements
An ophthalmic formulation, comprising:
- (a) aflibercept in a concentration of 5-100 mg/mL;
- (b) an acetate buffer at 5-50 mM concentration;
- (c) a non-ionic surfactant selected from the group consisting of a polysorbate at about 0.001% (w/v) to about 0.1% (w/v) concentration and a poloxamer at about 0.01% (w/v) to about 1% (w/v) concentration;
- and
- (d) a lysine salt as a tonicifying agent, at a concentration of about 2-3% (w/v), wherein the ophthalmic formulation has a final osmolality of 300+50 mOsm/kg;
- wherein the pH of the ophthalmic formulation is about pH 5.0 to about pH 5.5.
3 more elements
Dependencies are inferred from the claim text.