Etanercept formulations stabilized with xylitol
First Claim
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1. A stabilized aqueous pharmaceutical composition comprisinga) etanercept,b) buffer, andc) stabilizer comprising 6 to 10 weight % xylitol,wherein the composition has a pH of 6.0 to 6.6, or a pH within 10 percent of 6.0 and 6.6 and is free or essentially free of arginine.
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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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24 Claims
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1. A stabilized aqueous pharmaceutical composition comprising
a) etanercept, b) buffer, and c) stabilizer comprising 6 to 10 weight % xylitol, wherein the composition has a pH of 6.0 to 6.6, or a pH within 10 percent of 6.0 and 6.6 and is free or essentially free of arginine.
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14. A stabilized aqueous pharmaceutical composition comprising
a) 25 to 75 mg/mL of etanercept, b) buffer, and c) stabilizer comprising xylitol in an amount of 6 to 10 wt. % of the composition, wherein the composition has a pH of 6.3 or a pH within 10 percent of 6.3, and is free or essentially free of arginine.
Specification