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 producing a storage stable single-dose etanercept product comprising filling a syringe or injector pen with about 1 mL of a composition containing 25 to 75 mg/ml etanercept in an aqueous buffer that is stabilized with a stabilizing formulation 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 forming a filled syringe or injector pen containing a stable aqueous etanercept composition, wherein the stable aqueous etanercept composition is free of arginine.
A method of treating a subject suffering from rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, a psoriasis, or atopic dermatitis comprising administering a once weekly dose of about 50 mg/ml etanercept to the subject using a storage stable single-dose etanercept product comprising about 50 mg/ml etanercept in an aqueous buffer that is stabilized with a stabilizing formulation 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 product is free of arginine.
Dependencies are inferred from the claim text.