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US 2010/0075903 A1Published application
Lyophilized VEGF Antagonist Formulations for Intravitreal Administration
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsEric FURFINE, Daniel Dix, Kenneth S. Graham, Kelly Frye
Life of this patent
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Abstract
Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has the amino acid sequence shown in SEQ ID NO:4.
Claims9
A method of making a lyophilized formulation, comprising:
- lyophilizing a VEGF antagonist formulation, wherein the VEGF antagonist formulation comprises
- (a) 5-50 mg/ml of the VEGF antagonist of SEQ ID NO:4;
- (b) 5-25 mM of sodium phosphate buffer, pH about 5.8-7.0;
- (c) 0.01-0.15% of an organic co-solvent, selected from the group consisting of polysorbate, polyethylene glycol (PEG), propylene glycol, and a combination thereof;
- and,
- (d) 1-10% of a stabilizing agent selected from the group consisting of sucrose, sorbitol, glycerol, trehalose, and mannitol.
3 more elements
A method of making a lyophilized formulation, comprising:
- lyophilizing a VEGF antagonist formulation, wherein the VEGF antagonist formulation comprises
- (a) 5-50 mg/ml of the VEGF antagonist of SEQ ID NO:4;
- (b) 5-25 mM of a phosphate buffer, pH about 5.8-7.0;
- (c) 0.01-0.15% of an organic co-solvent, selected from the group consisting of polysorbate, polyethylene glycol (PEG), propylene glycol, and a combination thereof;
- and
- (d) 20-150 mM of a tonicity agent.
3 more elements
Dependencies are inferred from the claim text.