Process for preparing a pharmaceutical formulation of contrast agents
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United States of America Patent
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app pub date -
Jun 12, 2008
filing date -
Feb 19, 2008
priority date (Note) -
Abandoned
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Abstract
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, DO3A, BT-DO3A, HP-DO3A and PCTA, and is preferably DOTA, the said process comprising the following successive steps: a) determination of a theoretical target concentration of free macrocyclic chelate C.sub.tcl in the final liquid pharmaceutical formulation; 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.sub.cl and/or of free lanthanide C.sub.ll; d) adjustment of C.sub.cl and/or of C.sub.ll so as to obtain C.sub.cl=C.sub.tcl and C.sub.ll=0.
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