Etanercept Formulations Stabilized with Sodium Chloride
AssigneeCoherus Biosciences, Inc.
InventorsMark MANNING, Brian MURPHY
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Abstract
The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.
Claims20
A method of reducing formation of etanercept aggregates or fragments in a composition containing 25 to 75 mg/ml etanercept, the method comprising about 25 to about 75 mg/ml of etanercept with a stabilizing composition comprising about 3 to 5 wt. % of sucrose, sodium chloride, sodium citrate, and one or more amino acids selected from the group consisting of L-serine, sodium glutamic acid, alanine, glycine, and lysine, thereby preparing a stable aqueous etanercept composition, wherein the stable aqueous etanercept composition is free of arginine.
A method of treating a subject with an etanercept-containing composition comprising administering to the subject a stable aqueous pharmaceutical composition containing 25 to 75 mg/ml of an etanercept-containing protein mixture wherein the etanercept-containing protein mixture comprises greater than 90 wt. % correctly folded etanercept, and the stable aqueous pharmaceutical is stabilized with a stabilizing composition comprising about 3 to 5 wt. % of sucrose, sodium chloride, sodium citrate, and one or more amino acids selected from the group consisting of L-serine, sodium glutamic acid, alanine, glycine, and lysine, wherein the stable aqueous etanercept composition is free of arginine, wherein the stable aqueous pharmaceutical composition has less immunogenicity than commercially available etanercept.
Dependencies are inferred from the claim text.