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FORMULATIONS PHARMACEUTIQUES HAUTEMENT CONCENTRÉES
专利权人:
F. Hoffmann-La Roche AG
发明人:
申请号:
EP16156239.2
公开号:
EP3064196A1
申请日:
2010.09.10
申请国别(地区):
EP
年份:
2016
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. α,α-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.
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