Etanercept formulations stabilized with xylitol
View Patent ↗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.
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 T 2 of: monomer content greater than 90%.
2. A stabilized aqueous pharmaceutical composition comprising: 50 mg/ml of etanercept, but no arginine, and a stabilizer to inhibit instability, misfolding, aggregation and/or fragmentation of the etanercept, wherein the stabilizer comprises 6 weight by volume xylitol; and 10-30 mM sodium phosphate; and optionally up to 100 mM NaCl, wherein the formulation is characterized by an SEC analysis at T 2 of greater than 90 wt. % monomer content.
3. The composition of claim 1 or 2 having no more than, on average, 10,000 subvisible particles per mL having a size greater than 5 μm.