Back to results
US 2019/0290766 A1Published application
Stable Aqueous Etanercept Composition
AssigneeCoherus Biosciences, Inc.
InventorsMark Manning, Brian Murphy
Life of this patent
Estimating the term…
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.
Claims20
A stable aqueous pharmaceutical composition comprising:
- (a) about 25 to about 75 mg/mL etanercept;
- (b) about 1 to about 10 wt. % sugar;
- (c) up to about 10 wt. % polyol or an amino acid;
- and
- (d) an aqueous carrier;
- wherein said composition
- (i) is free of arginine,
- (ii) has a pH of about 6.0 to about 6.6, and
- (iii) has at M3 or T2 or T4 no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 μm, and
- wherein said sugar and said polyol are different from each other and wherein said amino acid is not cysteine and is not arginine, and the combination of said sugar and said polyol or amino acid stabilizes said etanercept in said stable aqueous pharmaceutical composition.
7 more elements
Dependencies are inferred from the claim text.