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HIGHLY CONCENTRATED PHARMACEUTICAL FORMULATIONS COMPRISING ANTI-CD20 ANTIBODY
专利权人:
F. HOFFMANN-LA-ROCHE AG
发明人:
ADLER MICHAEL,MAHLER HANNS-CHRISTIAN,STAUCH OLIVER BORIS
申请号:
TN2012000101
公开号:
TN2012000101A1
申请日:
2012.03.01
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-CD20 antibody, such as e.g. Rituximab, Ocrelizumab or 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 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.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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