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US 10,376,588 B2Granted
Etanercept formulations stabilized with combinations of sugars and polyols
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.
Claims13
A stable aqueous pharmaceutical composition comprising
- (a) about 50 mg/mL etanercept,
- (b) about 1 to about 10 wt. % sugar,
- (c) up to about 10 wt. % polyol, and
- (d) an aqueous carrier,
- wherein said composition
- (i) is free or essentially 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 the combination of said sugar and said polyol stabilizes said etanercept in said stable aqueous pharmaceutical composition.
6 more elements
Dependencies are inferred from the claim text.