Amgen Inc.
THE USE OF LOW MOLECULAR WEIGHT POLYVINYLPYRROLIDONE (PVP) TO REDUCE VISCOSITY OF HIGH CONCENTRATION PROTEIN FORMULATIONS

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 (.gtoreq.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.