HSA-FREE FORMULATION OF INTERFERON-&bgr;

摘要

PROBLEM TO BE SOLVED: To provide an additional IFN-β pharmaceutical composition which improves the solubility of IFN-β protein, stabilizes IFN-β protein against aggregation formation, enhances its pharmaceutical utility, and contains a physiologically suitable stabilizer.

SOLUTION: The stabilized HSA-free pharmaceutical composition includes: a substantially monomeric interferon (IFN-β) solubilized in a low-ionic strength formulation or its biologically active modification. The low-ionic strength formulation is a solution which contains a buffer fluid in an amount sufficient to maintain the pH of the composition in ±0.5 unit of a specific pH. The specific pH is about 3.0 to about 5.0. The formulation has an ionic strength not higher than about 60 mM.

COPYRIGHT: (C)2013,JPO&INPIT