ANTI HER2 ANTIBODY FORMULATION

To provide a pharmaceutical formulation comprising a therapeutically effective amount of an antibody, an acetate buffer, and pharmaceutically acceptable excipients.SOLUTION: A pharmaceutical formulation comprises an anti-HER2 antibody or a fragment thereof, one or more pharmaceutically acceptable excipients, and an acetate buffer. The pharmaceutical formulation is a liquid formulation, a lyophilized formulation or a reconstituted formulation. The anti-HER2 antibody or fragment thereof is present within the pharmaceutical formulation in an amount of 10-40 mg/ml. The pharmaceutically acceptable excipient is one or more surfactants, lyoprotectants, bulking agents, inorganic or organic salts, stabilizers, diluents, solubilizers, reducing agents, antioxidants, chelating agents and/or preservatives.SELECTED DRAWING: None 【課題】治療上有効量の抗体、酢酸緩衝液、薬学的に許容可能な賦形剤を含む医薬製剤。【解決手段】抗ＨＥＲ２抗体、又はその断片、１又は複数の薬学的に許容可能な賦形剤及び酢酸緩衝液を含む医薬製剤。医薬製剤が、液体製剤、凍結乾燥製剤または再構成製剤であり、抗ＨＥＲ２抗体またはその断片が、医薬製剤内に１０〜４０ｍｇ／ｍｌの量で存在する。薬学的に許容可能な賦形剤としては、１又は複数の界面活性剤、凍結乾燥保護剤、充填剤、無機もしくは有機塩、安定化剤、希釈剤、可溶化剤、還元剤、抗酸化剤、キレート剤及び／又は保存剤。【選択図】なし