A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 49/10 (2006.01) C07D 257/02 (2006.01)
Patent
CA 2714118
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 C chl and/or of free lanthanide C lanl; d)adjustmentof C chl and/or of C lanl so as to obtain C chl = C tchl and C lanl = 0, wherein C t chl is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.
Linvention concerne un procédé de préparation dune formule pharmaceutique liquide qui contient un complexe dun chélate macrocyclique avec un lanthanide et une quantité mol/mol dun chélate macrocyclique libre comprise entre 0,002 % et 0,4 %, avantageusement entre 0,02 % et 0,3 % et très avantageusement entre 0,025 % et 0,25 %. Le chélate macrocyclique est avantageusement choisi parmi DOTA, NOTA, DOTAGA, DO3A, BT-DO3A, HP-DO3A et PCTA, et est de préférence DOTA. Le procédé selon linvention comprend les étapes successives suivantes : b) préparation dune composition pharmaceutique liquide contenant, premièrement, le complexe dun chélate macrocyclique avec un lanthanide et, deuxièmement, un chélate macrocyclique libre et/ou un lanthanide libre; c) mesure dans la formulation pharmaceutique obtenue à létape b) de la concentration du chélate macrocyclique libre C chl et/ou du lanthanide libre C lanl; d) ajustement de C chl et/ou de C lanl pour obtenir C chl = C tchl et C lanl = 0, C tchl étant la concentration cible du chélate macrocyclique libre dans la formulation pharmaceutique liquide finale.
Barbotin Vincent
Bonnemain Bruno
Corot Claire
Meyer Dominique
Port Marc
Guerbet
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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