IL-1 antagonist formulations
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsDaniel Dix, Katherine Bowers, Chimanlall Goolcharran
Life of this patent
Estimating the term…
Abstract
Formulations of an interleukin-1 (IL-1) antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the IL-1 antagonist is an IL-1 trap composed of a dimer of two fusion protein having an amino acid sequence selected from the group consisting of SEQ ID NO:2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26. Most preferably, the fusion protein has the sequence of SEQ ID NO:10.
Claims19
A formulation of an interleukin-1 (IL-1) antagonist suitable for lyophilization, comprising an IL-1 protein antagonist capable of binding and inhibiting the biological action of IL-1, a buffer, and organic co-solvent or bulking agent, and one or more lyoprotectants.
A formulation of an interleukin-1 (IL-1) antagonist suitable for lyophilization, comprising an IL-1 protein antagonist capable of binding and inhibiting the biological action of IL-1, about 20 mM histidine, about 1.5% PEG 3350, about 0.5% glycine, about 25 mM arginine, about 1.0% sucrose, and about 5 to 50 mg/ml of an IL-1 antagonist, wherein the IL-1 antagonist is a dimer comprising two fusion proteins comprising an amino acid sequence selected from the group consisting of SEQ ID NO:2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26,
The method of claim 13, wherein the amino acid sequence is SEQ ID NO:10.
A stable liquid formulation of an IL-1 antagonist, comprising an IL-1 protein antagonist capable of binding and inhibiting the biological action of IL-1, a buffer, an organic co-solvent or bulking agent, and one or more thermal stabilizers.
The stable liquid formulation of claim 19, comprising 5-100 mM phosphate buffer, 0.5-3% PEG 3350, 25-150 mM NaCl, 5-30% sucrose and 10-120 mg/ml of an IL-1 protein antagonist.
Dependencies are inferred from the claim text.