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CABAZITAXEL COMPOSITION FOR INJECTION AND PREPARATION METHOD THEREFOR
专利权人:
BIKA BIOTECHNOLOGY (GUANGZHOU) CO.; LTD.
发明人:
Keqin TONG,Jinlan CHENG
申请号:
US16652356
公开号:
US20200268705A1
申请日:
2018.03.09
申请国别(地区):
US
年份:
2020
代理人:
摘要:
The present invention relates to a cabazitaxel composition for injection and a preparation method therefor. The composition comprises the following components in parts by weight: 1 part of cabazitaxel, 1 to 100 parts of cyclodextrin, 10 to 200 parts of a cosolvent, 1 to 60 parts of polyvidone (PVP), and 0.02 to 1.0 part of an additive. The composition does not contain polysorbate and ethanol. The composition of the present invention contains no polysorbate and ethanol, has low histamine release, and does not require the use of antihistamines, corticosteroids and H antagonists before administration. The composition is provided in a single ready-to-use vial, and serves as a new composition preparation that does not require two-step dilution. The preparation has characteristics of cabazitaxel, including high solubility and high stability. The preparation remains stable long after redissolution and is convenient to use clinically. Since the composition does not contain polysorbate and ethanol, side effects such as an allergic reaction, skin irritation, or addiction are reduced. Further disclosed is a preparation method of the cabazitaxel composition for injection.
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