Etanercept Formulations Stabilized with Combinations of Sugars and Polyols
First Claim
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1. A stable aqueous pharmaceutical composition comprising(a) about 50 mg/mL etanercept,(b) about 1 to about 10 wt. % sugar, and(c) up to about 10 wt. % polyol,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 μ
- m.
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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.
1 Citation
1 Claim
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1. A stable aqueous pharmaceutical composition comprising
(a) about 50 mg/mL etanercept, (b) about 1 to about 10 wt. % sugar, and (c) up to about 10 wt. % polyol, 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 μ - m.
Specification