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highly concentrated stable pharmaceutical formulations of a pharmaceutically active anti-her2 antibody, use of a formulation, injection device and kit

机译:药物活性抗her2抗体的高浓度稳定药物制剂,制剂,注射装置和试剂盒的用途

摘要

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPIN„¢), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ±,±-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.
机译:本发明涉及药物活性抗HER2抗体的高度浓缩,稳定的药物制剂,例如抗-HER2抗体。曲妥珠单抗(HERCEPIN™),帕妥珠单抗或T-DM1,或用于皮下注射的此类抗体分子的混合物。特别地,本发明涉及制剂,所述制剂除了包含合适量的抗HER2抗体之外,还包含有效量的至少一种透明质酸酶作为组合制剂或以共制剂形式使用。所述制剂还包含至少一种缓冲剂,例如,缓冲剂。组氨酸缓冲剂,稳定剂或两种或更多种稳定剂(例如,糖类,如±,±海藻糖二水合物或蔗糖,以及可选的蛋氨酸,作为第二种稳定剂)的混合物,非离子表面活性剂和有效量的至少一种透明质酸酶。还提供了制备这种制剂的方法及其用途。

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