Etanercept formulations stabilized with combinations of sugars and polyols
First Claim
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1. A stable aqueous pharmaceutical composition comprising about 25 to about 75 mg/ml etanercept in combination with a stabilizer to reduce instability, aggregation misfolding and/or fragmentation of the etanercept during storage of the formulation;
- said stabilizer consisting of about 1 to about 10 wt. % sugar, about 1 mM to about 30 mM sodium phosphate and up to about 10 wt. % polyol, wherein said sugar and said polyol are different from each other, and wherein said formulation 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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Citations
8 Claims
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1. A stable aqueous pharmaceutical composition comprising about 25 to about 75 mg/ml etanercept in combination with a stabilizer to reduce instability, aggregation misfolding and/or fragmentation of the etanercept during storage of the formulation;
- said stabilizer consisting of about 1 to about 10 wt. % sugar, about 1 mM to about 30 mM sodium phosphate and up to about 10 wt. % polyol, wherein said sugar and said polyol are different from each other, and wherein said formulation is free or essentially free of arginine.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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