Lyophilized VEGF antagonist formulations for intravitreal administration
First Claim
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1. 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;
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(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.
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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.
48 Citations
9 Claims
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1. A method of making a lyophilized formulation, comprising:
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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. - View Dependent Claims (2, 3, 4)
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5. A method of making a lyophilized formulation, comprising:
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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. - View Dependent Claims (6, 7, 8, 9)
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Specification