A kind of injection composition containing cabazitaxel and its preparation method

A cabazitaxel and composition technology, which is applied in the field of injection compositions, can solve problems such as large irritation, reduce ethanol, etc., and achieve the effects of simple production process, reduced solvent residual amount and related substance content, and easy industrialized operation.
CN103961345BInactive Publication Date: 2016-04-27JIANGSU AOSAIKANG PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
JIANGSU AOSAIKANG PHARMA CO LTD
Publication Date
2016-04-27
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a Jevtana-containing injection composition and a preparation method thereof. A mass ratio of Jevtana, polysorbate to citric acid in the Jevtana-containing injection composition is 1: 20-30: 0.05-0.25 and a tert-butyl alcohol residual quantity ratio is less than 0.5%. The preparation method utilizes tert-butyl alcohol as a solvent and a mass ratio of Jevtana to tert-butyl alcohol is 1: 20-45. The preparation method comprises the following steps of adding polysorbate-80 and citric acid into tert-butyl alcohol, carrying out stirring for dissolution, adding Jevtana into the solution for dissolution, carrying out sterilization filtration, carrying out split charging and carrying out vacuum removal of tert-butyl alcohol.
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Description

technical field

[0001] The invention relates to an injection composition with cabazitaxel as an active ingredient and a preparation method thereof. Background technique

[0002] Cabazitaxel belongs to taxane antineoplastic drugs, which is prepared by semi-synthesis of precursors extracted from Taxus chinensis. The FDA of the United States and the EMA of the European Union successively approved the marketing of this product in June 2010 and March 2011 respectively. It is used in combination with prednisone to treat hormone-refractory metastatic prostate cancer previously treated with docetaxel-containing regimens. Cabazitaxel is white to off-white powder with molecular formula C 45 h 57 NO 14 , molecular weight 835.93, its lipophilicity, insoluble in water, soluble in ethanol, the structural formula is as follows:

[0003]

[0004] Cabazitaxel injection (Jevtana TM ) is a combined package of two vials, one of which contains 1.5ml of concentrated drug solution, and the...

Claims

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