Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing
First Claim
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1. A stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, a surfactant and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.
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Abstract
The present invention provides for improved compositions comprising a PEGsTNF-R1 which, in addition to having useful higher concentrations, demonstrate decreased viscosity (<400 cP) and improved stability.
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Citations
16 Claims
- 1. A stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, a surfactant and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.
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15. An article of manufacture comprising a container holding a stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.
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16. A method of making a stable pharmaceutical formulation comprising:
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a) admixing at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, and a buffer, and b) adjusting the pH to between pH 4.0 and 5.5, wherein said pharmaceutical formulation has a viscosity less than 400 cP.
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Specification