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Patent Searching and Data


Title:
CABAZITAXEL COMPOSITION FOR INJECTION AND PREPARATION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2019/136817
Kind Code:
A1
Abstract:
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 povidone (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 H2 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.

Inventors:
TONG KEQIN (CN)
CHENG JINLAN (CN)
Application Number:
PCT/CN2018/078567
Publication Date:
July 18, 2019
Filing Date:
March 09, 2018
Export Citation:
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Assignee:
BIKA BIOTECHNOLOGY GUANGZHOU CO LTD (CN)
International Classes:
A61K47/69; A61K9/08; A61K9/19; A61K31/337; A61K47/02; A61K47/10; A61K47/12; A61K47/32; A61P35/00; A61P35/04
Foreign References:
CN101484137A2009-07-15
CN105142671A2015-12-09
CA2900508A12014-08-14
US20150325321A12015-11-12
Other References:
See also references of EP 3698812A4
Attorney, Agent or Firm:
LEADING INTELLECTUAL PROPERTY FIRM (CN)
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