STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF IGG ANTIBODIES

摘要

This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more,of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5,about 0.005 % - 0.03 % polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, andis suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal,or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.