Viscosity-reducing excipient compounds for protein formulations

摘要

The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions.

主权项

1. A liquid pharmaceutical formulation comprising a therapeutic antibody and a viscosity-reducing amount of caffeine, wherein (i) the viscosity of the formulation is at least about 50% less than the viscosity of a control formulation and is less than about 50 cP, (ii) the formulation contains at least about 100 mg/mL of the antibody, and (iii) the viscosity reducing amount of caffeine is about 15 mg/ml or less;
wherein the control formulation does not contain the caffeine but is otherwise identical on a dry weight basis to the liquid pharmaceutical formulation.