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Etanercept formulations stabilized with xylitol

  • US 9,393,305 B2
  • Filed: 10/18/2012
  • Issued: 07/19/2016
  • Est. Priority Date: 10/18/2011
  • Status: Active Grant
First Claim
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1. A stabilized aqueous pharmaceutical composition comprising 50 mg/ml etanercept, but no arginine, and a stabilizer to inhibit instability, misfolding, aggregation and/or fragmentation of the etanercept, wherein the stabilizer comprises 10% weight by volume xylitol, 10-30 mM sodium phosphate, and optionally up to 100 mM NaCl, and eliciting long term storage stability as characterized bySEC (size exclusion chromatography) analysis at T2 of:

  • monomer content greater than 90%.

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