Etanercept formulations stabilized with xylitol
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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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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3 Claims
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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 by
SEC (size exclusion chromatography) analysis at T2 of: - monomer content greater than 90%.
- View Dependent Claims (3)
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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 T2 of greater than 90 wt. % monomer content.
- 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
Specification