MEYER, DOMINIQUE,COROT, CLAIRE,PORT, MARC,BARBOTIN, VINCENT,BONNEMAIN, BRUNO
申请号：
CA2714118
公开号：
CA2714118C
申请日:
2009.02.18
申请国别(地区):
CA
年份:
2017
代理人:
摘要：
The invention relates to a process for preparing a liquid pharmaceuticalformulation containing a complex ofmacrocyclic chelate with a lanthanide and a mol/mol amount offree macrocyclicchelate of between 0.002% and 0.4%, advantageouslybetween 0.02% and 0.3% and very advantageously between 0.025% and 0.25%, themacrocyclic chelate advantageouslybeing chosen from DOTA, NOTA, DOTAGA, DO3A, BT-DO3A, HP-DO3A and PCTA, and ispreferably DOTA, the said processcomprising the following successive steps: b) preparation of a liquidpharmaceutical composition containing, firstly, the complexof macrocyclic chelate with a lanthanide, and, secondly, free macrocyclicchelate and/or free lanthanide c) measurement inthe pharmaceutical formulation obtained in step b) of the concentration offree macrocyclic chelate C chl and/or of free lanthanideC lanl d)adjustmentof C chl and/or of C lanl so as to obtain C chl = C tchland C lanl = 0, wherein C t chl is the target concentrationof free macrocyclic chelate in the final liquid pharmaceutical formulation.
