发明授权
- 专利标题： PROCESS FOR PREPARING A PHARMACEUTICAL FORMULATION OF CONTRAST AGENTS
- 专利标题（中）： 方法制备药物染料制剂
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申请号： EP09712403.6申请日： 2009-02-18
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公开(公告)号： EP2242515B9公开(公告)日： 2014-10-01
- 发明人: MEYER, Dominique , COROT, Claire , PORT, Marc , BARBOTIN, Vincent , BONNEMAIN, Bruno
- 申请人： GUERBET
- 申请人地址： 15, Rue des Vanesses 93420 Villepinte FR
- 专利权人： GUERBET
- 当前专利权人： GUERBET
- 当前专利权人地址： 15, Rue des Vanesses 93420 Villepinte FR
- 代理机构： Regimbeau
- 优先权： FR0851055 20080219; EP08154745 20080417; US155997 20080612
- 国际公布： WO2009103744 20090827
- 主分类号： A61K49/10
- IPC分类号： A61K49/10
摘要：
The invention relates to a process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4%, advantageously between 0.02% and 0.3% and very advantageously between 0.025% and 0.25%, the macrocyclic chelate advantageously being chosen from DOTA, NOTA, DOTAGA, D03A, BT-D03A, HP-D03A and PCTA, and is preferably DOTA, the said process comprising the following successive steps: b) preparation of a liquid pharmaceutical composition containing, firstly, the complex of macrocyclic chelate with a lanthanide, and, secondly, free macrocyclic chelate and/or free lanthanide; c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate C ch1 and/or of free lanthanide C lan 1 ; d) adjustment of C ch 1 and/or of C lan 1 so as to obtain C ch 1 = Ct ch 1 and C lan 1 = 0, wherein C t ch 1 is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.
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