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