Patent ID: 8580246
Filing Date: 2013-11-12
Classification: A61K,A61P,C07K

Abstract:
1. A stable pharmaceutical composition of non-glycosylated granulocyte-colony stimulating factor (G-CSF), wherein the composition has a pH in the range from 4.2 to 4.8 and comprises: sorbitol in an amount of from about 1% to about 10% (m/v), a therapeutically effective amount of G-CSF, an acid, a pH buffering system, and optionally, one or more pharmaceutical-acceptable excipients, wherein the acid is acetic acid and the pH buffering system is acetic acid/acetate, wherein the concentration of acetic acid is in a range from about 0.15 mM to about 15 mM, and wherein the composition is free of surfactants.