Preparation of a solid form of gadobenate dimeglumine
AssigneeBracco Imaging S.P.A.
InventorsRoberta Mazzon, Roberta Fretta, Pier Lucio Anelli
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Abstract
The present invention relates to a process for the preparation of a solid form of the gadobenate dimeglumine compound that comprises obtaining a solution of the said compound in a suitable solvent A wherein the amount by weight of the water optionally present in the solution is at most equal to or lower than the amount by weight of the gadobenate dimeglumine comprised in the solution and adding the obtained solution to an organic solvent B, acting as an appropriate antisolvent and favoring the formation of a solid form of the gadobenate dimeglumine that can be collected by filtration.
Claims20
A process for a preparation of a filterable solid form of gadobenate dimeglumine compound of formula
- that comprises:
- a) obtaining a solution of the gadobenate dimeglumine in a solvent A selected from the group consisting of water, aqueous solvents, organic solvents having a log P value no greater than −0.5, and mixtures thereof, wherein the amount by weight of the water optionally present in the solution is no more than the amount by weight of the gadobenate dimeglumine in the solution;
- b) adding the obtained solution of the gadobenate dimeglumine to an antisolvent B, to obtain the filterable solid form of the gadobenate dimeglumine;
- and
- c) collecting the obtained filterable solid form of the gadobenate dimeglumine wherein the pair of the solvent A:the antisolvent B is selected from the group consisting of water:2-propanol;
- aqueous solvent:acetone;
- MeOH:2-propanol;
- MeOH:acetone;
- MeOH:AcOEt;
- MeOH:Diglyme;
- DMF:2-propanol;
- MeOH:2-butanol;
- ethylene glycol:2-propanol;
- MeOH:n-butanol;
- and MeOH:MIBK.
Dependencies are inferred from the claim text.