Stable Aqueous Etanercept Composition
AssigneeCoherus Biosciences, Inc.
InventorsMark Manning, Brian Murphy
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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.
Claims20
A stable aqueous pharmaceutical composition comprising
- (a) about 25 to about 75 mg/mL etanercept,
- (b) about 1 to about 10 wt. % sucrose,
- (c) up to about 10 wt. % polyol or an amino acid, wherein the sucrose has a ratio of between 5:1 to 1:5 to the polyol or the 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 amino acid is not cysteine and is not arginine, and the combination of said sucrose and said polyol or amino acid stabilizes said etanercept in said stable aqueous pharmaceutical composition.
A vial, syringe, or injector pen containing a stable aqueous etanercept composition comprising about 25 to about 75 mg/ml etanercept, about 1 to about 10 wt. % sugar, about 0.1 to 2 wt. % polyol or amino acid, wherein the polyol or amino acid is mannitol, sorbitol, lysine, or a combination thereof, the aqueous pharmaceutical composition having a pH of about 6.0 to 6.6, wherein the aqueous pharmaceutical composition is free or essentially free of arginine, and wherein said sugar and said polyol are different from each other and the combination of said sugar and said polyol or amino acid stabilizes said etanercept in said aqueous pharmaceutical composition.
Dependencies are inferred from the claim text.