Reducing viscosity of pharmaceutical formulations
AssigneeAmgen Inc.
InventorsHolly Zhuohong Huang, Dingjiang Liu, Christopher J. Sloey, Camille Gleason
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Abstract
A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from taurine, theanine, sarcosine, citrulline and betaine.
Claims17
A method for reducing the viscosity of a liquid pharmaceutical formulation comprising a therapeutic protein at a concentration of at least 70 mg/ml, comprising the step of combining the therapeutic protein with a viscosity-reducing concentration of an excipient selected from the group consisting taurine, theanine, sarcosine, citrulline, betaine and mixtures thereof.
A pharmaceutical composition comprising a therapeutic protein at a concentration of at least 70 mg/mL, and an excipient selected from the group consisting of taurine, theanine, sarcosine, citrulline, betaine and mixtures thereof.
A method of preparing a lyophilized powder comprising the step of lyophilizing a pharmaceutical formulation comprising a therapeutic protein at a concentration of at least 70 mg/mL, and an excipient selected from the group consisting of taurine, theanine, sarcosine, citrulline, betaine and mixtures thereof.
A lyophilized powder comprising a therapeutic protein and an excipient selected from the group consisting of taurine, theanine, sarcosine, citrulline, betaine and mixtures thereof, wherein the excipient is present at a weight:weight concentration effective to reduce viscosity upon reconstitution with a diluent.
Dependencies are inferred from the claim text.