MEYER, DOMINIQUE,COROT, CLAIRE,PORT, MARC,BARBOTIN, VINCENT,BONNEMAIN, BRUNO
申请号：
ES09712403
公开号：
ES2477541T3
申请日:
2009.02.18
申请国别(地区):
ES
年份:
2014
代理人:
摘要：
Process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and mol / mol amount of free macrocyclic chelate of between 0.002% and 0.4%, said process comprising the following successive steps: b) preparation of a liquid pharmaceutical composition containing the complex of macrocyclic chelate with a lanthanide chelate free macrocyclic that is not in the form of an X excipient [X , L] in which L is the macrocyclic chelate and X and X are a metal ion, in particular chosen independently from calcium, sodium, zinc and magnesium, and free lanthanide mixing a solution of free macrocyclic chelate and of free lanthanide, for complexing lanthanide by the macrocyclic chelate, the quantities of macrocyclic chelate free and free lanthanide such that not all the lanthanide complexes c) measurement in the pharmaceutical formulation obtained in step b) the concentration of free lanthanide Clan l the concentration of free macrocyclic chelate Cch l equal to 0 d) setting Cch l of Clan l by adding to the formulation obtained in step b) the amount of free macrocyclic chelate necessary, firstly, to complete the complexation of the free lanthanide for Clan l> = 0, and, secondly , to obtain Cch l> = Ct ch l, wherein Ct ch l is the concentration of free macrocyclic target chelate in the final liquid pharmaceutical formulation and is selected in the range of between 0.002% and 0.4% mol / mol wherein the amount of free macrocyclic chelate in the final liquid pharmaceutical formulation corresponds to the proportion of free macrocyclic chelate relative to the amount of macrocyclic chelate complexed in the final liquid pharmaceutical formulation.Proceso para preparar una formulación farmacéutica líquida que contiene un complejo de quelato macrocíclico con un lantánido y una cantidad mol/mol de quelato macrocíclico libre de entre el 0,002% y el 0,4%, comprendiendo dicho proceso las siguientes etapas sucesivas: b) preparación de una compo
