Crystallisation and purification of glycopyrronium bromide

Details Crystallisation and purification of glycopyrronium bromide Crystallisation and purification of glycopyrronium bromide

C - Chemistry, Metallurgy

07

D

C07D 207/12 (2006.01) A61K 31/40 (2006.01) A61P 1/06 (2006.01) A61P 13/06 (2006.01)

Patent

CA 2601129

A method for the production of crystalline glycopyrronium bromide, comprises the reaction of glycopyrronium base with methyl bromide in a solvent, in which the solvent is selected such that the diastereoisomeric ratio of the product favours the R,S and S,R diastereoisomers over the R,R, and S,S diastereoisomers, and separating the desired diastereoisomers by one or more controlled crystallisation steps. This method gives a product having a particle size of narrow distribution.

La présente invention concerne un procédé de production de bromure de glycopyrronium cristallin, qui comprend la réaction d~une base de glycopyrronium avec du bromure de méthyle dans un solvant, dans lequel le solvant est sélectionné de sorte que le rapport des diastéréoisomères du produit favorise les diastéréoisomères R,S et S,R par rapport aux diastéréoisomères R,R et S,S. Le procédé comprend également la séparation des diastéréoisomères souhaités par l~intermédiaire d~une ou plusieurs étapes contrôlées de cristallisation. Ce procédé donne un produit dont la granulométrie suit une distribution étroite.

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