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Formulation of contrast product and its associated preparation procedure
专利权人:
Guerbet
发明人:
MEDINA, Christelle,SABATOU, Monique,PETIT, Anne,PORT, Marc
申请号:
ES14723750
公开号:
ES2626582T3
申请日:
2014.04.28
申请国别(地区):
ES
年份:
2017
代理人:
摘要:
Liquid pharmaceutical composition comprising a complex of formula (I): ** Formula ** in which R1, R2 and R3 represent -COOH, X1, X2 and X3 independently represent each other LY in which L represents an alkylene group C1-C3, preferably (CH2) n with n>; = 1 to 3, Y represents -CONH2, -CO-NR7R8 or -NR7-CO-R8, where R7 represents H or a C1-10 C6 alkyl group or a C1-C6 hydroxyalkyl group, in particular C2-C4, advantageously - CH2-CH2OH, -CHOH-CH2OH, -CH- (CH2OH) 2, - (CH2) m- (CHOH) p-CH2OH with m>; = 1 at 3, p>; = 1 to 4 and m + p>; = 2 to 5 or -C- (CH2OH) 3 and R8 represents a C1-C6 alkyl or C1-C6 hydroxyalkyl group, in particular C2-C4, advantageously - CH2-CH2OH, -CHOH-CH2OH, -CH- (CH2OH) 2, - (CH2) m- (CHOH) p-CH2OH with m>; = 1 to 3, p>; = 1 to 4 and m + p>; = 2 a 5 or -C- (CH2OH) 3, with the proviso that at least R7 or R8 represents a C1-C6 hydroxyalkyl group; D represents CH or N; E represents CH or N; F1 represents CH or N; K1 to K12 each independently represent H, - (CH2) j-CH3 or - (CH2) i-OH in which j>; = 0 to 3 and i>; = 1 to 3, advantageously H, or K3 or K4 with K5 or K6, and / or K7 or K8 with K9 or K10 form a cycle having 3 to 6 carbon atoms; and M represents an ion of a paramagnetic metal; or an enantiomer, or a diastereoisomer (preferably chosen from the RRS, RSR, RSS) diastereoisomers thereof or mixtures thereof, said composition further comprising a calcium complex of 1,4,7,10-tetraazacyclododecane-1,4,7 , 10-tetraacetic and having a concentration of free paramagnetic metal less than 1 ppm (m / v), preferably less than 0.5 ppm (m / v).Composición farmacéutica líquida que comprende un complejo de fórmula (I):**Fórmula** en la que R1, R2 y R3 representan -COOH, X1, X2 y X3 representan independientemente el uno del otro L-Y en la que L representa un grupo alquileno C1-C3, preferentemente (CH2)n con n >;= 1 a 3, Y representa -CONH2, -CO-NR7R8 o -NR7-CO-R8, en los que R7 representa H o un grupo alquilo C1-10 C6 o un grupo hidroxialquil
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