Etanercept formulations stabilized with xylitol
First Claim
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1. A method of reducing formation of etanercept aggregates or fragments in an aqueous composition containing 25 to 75 mg/ml etanercept, the method comprising combininga) etanercept,b) buffer, andc) stabilizer comprising 6 to 10 weight % (wt. %) xylitol,wherein the aqueous composition has a pH of 6.0 to 6.6, or a pH within 10 percent of 6.0 and 6.6, wherein the aqueous composition is free or essentially free of arginine, thereby preparing the aqueous composition.
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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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15 Claims
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1. A method of reducing formation of etanercept aggregates or fragments in an aqueous composition containing 25 to 75 mg/ml etanercept, the method comprising combining
a) etanercept, b) buffer, and c) stabilizer comprising 6 to 10 weight % (wt. %) xylitol, wherein the aqueous composition has a pH of 6.0 to 6.6, or a pH within 10 percent of 6.0 and 6.6, wherein the aqueous composition is free or essentially free of arginine, thereby preparing the aqueous composition.
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15. A vial, syringe, or injector pen containing a aqueous composition comprising 25 to 75 mg/ml etanercept and 6 to 10 wt. % xylitol in an aqueous pharmaceutical composition having a pH of 6.0 to 6.6 or a pH within 10 percent of 6.0 and 6.6, wherein the composition is free or essentially free of arginine.
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