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发明授权
EP2799089B1 Process for preparing a pharmaceutical formulation of contrast agents 有权
Verfahren zur Herstellung einer pharmazeutischen Formulierung aus Kontrastmitteln

  • 专利标题： Process for preparing a pharmaceutical formulation of contrast agents
  • 专利标题（中）： Verfahren zur Herstellung einer pharmazeutischen Formulierung aus Kontrastmitteln
  • 申请号： EP14165006.9
    申请日： 2009-02-18
  • 公开(公告)号： EP2799089B1
    公开(公告)日： 2016-08-03
  • 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
  • 主分类号： A61K49/10
  • IPC分类号： A61K49/10 ;  A61K51/04
Process for preparing a pharmaceutical formulation of contrast agents
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.
摘要（中）：

本发明涉及制备含有大环螯合物与镧系元素络合物和摩尔/摩尔量的游离大环螯合物的液体药物制剂的方法，其中0.002％至0.4％之间，有利地在0.02％至0.3％之间，非常有利地介于 0.025％和0.25％，大环螯合物有利地选自DOTA，NOTA，DOTAGA，D03A，BT-D03A，HP-D03A和PCTA，并且优选为DOTA，所述方法包括以下连续步骤：b） 液体药物组合物首先含有大环螯合物与镧系元素的复合物，其次是游离的大环螯合物和/或游离的镧系元素; c）在步骤b）中获得的药物制剂中测量游离大环螯合物C ch1和/或游离镧​​系元素的浓度C lan 1; d）调节C ch 1和/或C lan 1，以获得C ch 1 = Ct ch 1和C lan 1 = 0，其中C t ch 1是游离大环螯合物在最终液体药物中的目标浓度 公式。

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