Etanercept formulations stabilized with meglumine
First Claim
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1. A stable aqueous stabilized formulation of etanercept comprising:
- about 50 mg/ml etanercept;
a buffer selected from the group consisting of phosphate, histidine, citrate, maleate, tartrate, succinate, acetate, tris-(hydroxymethyl)-aminomethane and bicarbonate;
0.5-5 wt. % meglumine; and
optionally sucrose, sodium chloride, or sucrose and sodium chloride, wherein the formulation is free or essentially free of arginine, wherein the formulation has a monomer content greater than 85 wt. % after two weeks of storage.
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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.
21 Citations
7 Claims
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1. A stable aqueous stabilized formulation of etanercept comprising:
- about 50 mg/ml etanercept;
a buffer selected from the group consisting of phosphate, histidine, citrate, maleate, tartrate, succinate, acetate, tris-(hydroxymethyl)-aminomethane and bicarbonate;
0.5-5 wt. % meglumine; and
optionally sucrose, sodium chloride, or sucrose and sodium chloride, wherein the formulation is free or essentially free of arginine, wherein the formulation has a monomer content greater than 85 wt. % after two weeks of storage. - View Dependent Claims (3, 4, 5, 6)
- about 50 mg/ml etanercept;
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2. A stable aqueous stabilized formulation of etanercept comprising:
- about 50 mg/mi etanercept;
about 0.5 wt % megiumine;
about 10 to 30 mM phosphate;
about 1% sucrose; and
about 100 mM sodium chloride, wherein the formulation is free or essentially free of arginine, wherein the formulation has a monomer content greater than 85 wt. % after two weeks of storage. - View Dependent Claims (7)
- about 50 mg/mi etanercept;
Specification
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Current AssigneeCoherus BioSciences Inc.
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Original AssigneeCoherus BioSciences Inc.
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InventorsManning, Mark, Murphy, Brian
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Primary Examiner(s)Ford, Vanessa L.
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Assistant Examiner(s)Dillahunt, Sandra E
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Application NumberUS13/654,903Publication NumberTime in Patent Office2,595 DaysField of SearchNoneUS Class CurrentCPC Class CodesA61K 38/1793 for cytokines; for lymphoki...A61K 39/39591 Stabilisation, fragmentationC07K 2319/30 Non-immunoglobulin-derived ...
