Etanercept formulations stabilized with metal ions
First Claim
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1. A stable aqueous pharmaceutical composition containing no arginine or essentially free of arginine comprising about 50 mg/mL etanercept and 5 to 10 mM magnesium, wherein the composition has a pH of about 6.0 to 6.6.
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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.
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Citations
24 Claims
- 1. A stable aqueous pharmaceutical composition containing no arginine or essentially free of arginine comprising about 50 mg/mL etanercept and 5 to 10 mM magnesium, wherein the composition has a pH of about 6.0 to 6.6.
- 11. A stabilized etanercept composition containing no arginine, or essentially free of arginine, comprising about 50 mg/mL etanercept, 5 to 10 mM magnesium chloride, optionally up to about 6 wt. % sucrose, about 25 to 150 mM NaCl, and about 1 to about 30 mM sodium phosphate, wherein the composition has a pH from about 6.0 to 6.6.
Specification