ADLER, Michael,MAHLER, Hanns-Christian,STAUCH, Oliver Boris
申请号：
AU2013266987
公开号：
AU2013266987B2
申请日:
2013.12.03
申请国别(地区):
AU
年份:
2016
代理人:
摘要：
#$%^&*AU2013266987B220161110.pdf#####Abstract The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab or 5 HuMab<；CD20>；, 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-CD20 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 10 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. 4924725_1 (GHMatters) P89561.AU.1
