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PROCESS FOR PREPARING A PHARMACEUTICAL FORMULATION OF CONTRAST AGENTS
专利权人:
发明人:
Dominique MEYER,Claire COROT,Marc PORT,Vincent BARBOTIN,Bruno BONNEMAIN
申请号:
US13971672
公开号:
US20130336898A1
申请日:
2013.08.20
申请国别(地区):
US
年份:
2013
代理人:
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 offree 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, DO3A, BT-DO3A, HP-DO3A 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 Cch1 and/or of free lanthanide Clan1 d) adjustment of Cch1 and/or of Clan1 so as to obtain Cch1=Ct ch1 and Clan1=0, wherein Ct ch1 is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.
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