A process for the preparation of a pharmaceutically pure...

Details A process for the preparation of a pharmaceutically pure... A process for the preparation of a pharmaceutically pure...

C - Chemistry, Metallurgy

07

D

C07D 495/04 (2006.01)

Patent

CA 2506663

The present invention relates to a process for the preparation of pharmaceutically pure polymorphic form I of olanzapine, which com-prises crystallization of olanzapine from a solution in methylene chlo-ride, wherein before the crystallization, said solution of olanzapine in methylene chloride is treated with silica gel, preferably at reflux tem-perature. Also disclosed is form I of olanzapine substantially free of im-purity S, as well as a process for removing of impurity S from olanzap-ine polymorphic form I.

L'invention concerne un procédé de préparation d'une forme polymorphe 1 pure sur le plan pharmaceutique d'olanzapine. Ce procédé consiste à cristalliser une olanzapine à partir d'une solution dans du chlorure de méthylène, avant la cristallisation, la solution d'olanzapine dans le chlorure de méthylène étant traitée au moyen de gel de silice, de préférence à une température de reflux. L'invention concerne également la forme I d'olanzapine sensiblement exempte d'impureté S, ainsi qu'un procédé permettant d'éliminer des impuretés S de la forme polymorphe I d'olanzapine.

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