MAHLER, Hanns-Christian,STAUCH, Oliver Boris,ADLER, Michael,GRAUSCHOPF, Ulla
申请号：
MX2013009895
公开号：
MX355450B
申请日:
2010.07.28
申请国别(地区):
MX
年份:
2018
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 (HERCEPINâ„¢), 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.La presente invención se refiere a una formulación líquida farmacéutica estable, altamente concentrada, de un anticuerpo anti-HER2 farmacéuticamente activo para inyección subcutánea que comprende: a. 120+/- 18 mg/ml de anticuerpo anti-HER2； b. 1 a 50 mM de un tampón histidina proporcionando un pH de 5.5 ± 2.0； c. 15 a 250 mM de a,a-trehalosa-dihidrato o sacarosa, y 5 a 25 mM de metionina； d. 0.01 a 0.08% de un tensiactivo no iónico, en donde dicho anticuerpo anti-HER2 es Trastuzumab para la reconstitución con 150 a 16´000 U/ml, 2000 U/ml o 12´000 U/ml de una enzima de hialuronidasa.
