Etanercept formulations stabilized with xylitol

摘要

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.

主权项

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 by
SEC (size exclusion chromatography) analysis at T2 of: monomer content greater than 90%.