ADLER MICHAEL,GRAUSCHOPF ULLA,MAHLER HANNS-CHRISTIAN,STAUCH OLIVER BORIS
申请号：
TN2012000023
公开号：
TN2012000023A1
申请日:
2012.01.16
申请国别(地区):
TN
年份:
2013
代理人:
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. ل,ل-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.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 antibodyAn 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.L, L - 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.
