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,(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 μ
- m, andwherein 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.
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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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13 Claims
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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, (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 μ - m, 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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Specification