Sublethal formulations of injections with high concentrations of anti-HER2 antigens, including antigens, shock absorbers, stabilizers, non-ionizing surfactants and hyaluronidase； syringes； toolkits and formulations for the treatment of such diseases It's like cancer.
MAHLER, HANNS-CHRISTIAN,ADLER, MICHAEL,GRAUSCHOPF, ULLA,STAUCH, OLIVER BORIS
申请号：
CL2012000269
公开号：
CL2012000269A1
申请日:
2012.01.31
申请国别(地区):
CL
年份:
2012
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. ±,±-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.FORMULACION FARMACEUTICA INYECTABLE SUBCUTANEA ALTAMENTE CONCENTRADA DE UN ANTICUERPO ANTI-HER2 QUE COMPRENDE DICHO ANTICUERPO, UN AMORTIGUADOR, UN ESTABILIZADOR, UN TENSIOACTIVO NO IONICO Y UNA ENZIMA HIALURONIDASA； DISPOSITIVO DE INYECCION； KIT Y USO DE LA FORMULACION PARA TRATAR ENFERMEDADES TALES COMO CANCER.
