ADLER MICHAEL,GRAUSCHOPF ULLA,MAHLER HANNS CHRISTIAN,STAUCH OLIVER BORIS
申请号：
IN961/CHENP/2012
公开号：
IN2012CN00961A
申请日:
2012.01.31
申请国别(地区):
IN
年份:
2013
代理人:
摘要：
Abstract 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. a a-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.
