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Etanercept formulations stabilized with combinations of sugars and polyols

  • US 9,302,002 B2
  • Filed: 10/18/2012
  • Issued: 04/05/2016
  • Est. Priority Date: 10/18/2011
  • Status: Active Grant
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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