Use of low molecular weight polyvinylpyrrolidone (PVP) to reduce viscosity of high concentration protein formulations
AssigneeAmgen Inc.
InventorChristopher James Sloey
Life of this patent
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Abstract
Disclosed herein are pharmaceutical compositions (formulations) having reduced viscosity, using a low molecular weight polyvinylpyrrolidone (povidone) in the case of high therapeutic protein concentration (≥70 mg/ml) formulations. The addition of arginine, such as arginine monohydrochloride or N-acetyl arginine, can further reduce viscosity. Appropriate therapeutic proteins include antibodies, such as monoclonal antibodies, and derivatives, fragments, and analogues thereof.
Claims15
A method of reducing the viscosity of a pharmaceutical formulation comprising a therapeutic protein at a concentration, wherein said concentration is at least 70 mg/mL, the method comprising combining the therapeutic protein with a viscosity-reducing concentration of polyvinylpyrrolidone (PVP), thereby producing a reduced viscosity formulation that comprises the therapeutic protein at said concentration, wherein the PVP has an average molecular weight of 2,000 Da to 25,000 Da.
A method of reducing the viscosity of a pharmaceutical formulation comprising a monoclonal antibody at a concentration, wherein said concentration is at least 70 mg/mL, the method comprising combining the monoclonal antibody with PVP, the PVP having a K value of 12-17, thereby producing a reduced viscosity formulation comprising the therapeutic protein at said concentration, wherein the viscosity of the reduced viscosity formulation is at least 10% lower than a control formulation lacking PVP.
Dependencies are inferred from the claim text.