Method of Reducing Formation of Etanercept Aggregates or Fragments
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 about 25 to about 75 mg/ml etanercept, comprising combining about 25 to about 75 mg/ml etanercept with about 1 to about 10 wt. % sugar and up to about 10 wt. % polyol, in an aqueous pharmaceutical composition having a pH of about 6.0 to 6.6, wherein the aqueous pharmaceutical composition is free or essentially free of arginine, and wherein said sugar and said polyol are different from each other and the combination of said sugar and said polyol stabilizes said etanercept in said stable aqueous pharmaceutical composition, thereby preparing a stable aqueous etanercept composition.
A method of treating a subject in need of treatment for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Wegener's disease (granulomatosis), Crohn's disease (or inflammatory bowel disease), chronic obstructive pulmonary disease (COPD), Hepatitis C, endometriosis, asthma, cachexia, psoriasis, or atopic dermatitis comprising administering to the subject an aqueous pharmaceutical composition comprising about 25 to about 75 mg/ml etanercept, about 1 to about 10 wt. % sugar, up to about 10 wt. % polyol, an aqueous buffer, the aqueous pharmaceutical composition having a pH of about 6.0 to 6.6, wherein the aqueous pharmaceutical composition is free or essentially free of arginine, and wherein said sugar and said polyol are different from each other and the combination of said sugar and said polyol stabilizes said etanercept in said aqueous pharmaceutical composition.
A vial, syringe, or injector pen containing a stable aqueous etanercept composition comprising about 25 to about 75 mg/ml etanercept, about 1 to about 10 wt. % sugar, up to about 10 wt. % polyol, an aqueous buffer, the composition having a pH of about 6.0 to 6.6, wherein the composition is free or essentially free of arginine, and wherein said sugar and said polyol are different from each other and the combination of said sugar and said polyol stabilizes said etanercept in said stable aqueous etanercept composition.
Dependencies are inferred from the claim text.