A factory scale process for producing crystalline...

C - Chemistry – Metallurgy – 07 – D

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C07D 207/34 (2006.01) C07D 405/06 (2006.01)

Patent

CA 2388226

A factory scale process for producing crystalline atorvastatin trihydrate hemi calcium salt includes the addition of extra methyl tert-butyl ether to the reaction mixture to supersaturate the crystallisation matrix. A seed slurry is made up in a make-up/delivery vessel and delivered, under pressure, to the reaction mixture. The process produces crystalline atorvastatin calcium, having structure (I) within a consistent size range on a factory scale.

La présente invention concerne un procédé de production à l'échelle industrielle de sel d'hémi-calcium trihydraté d'atorvastatine cristallisé, comprenant l'adjonction de méthyl tert-butyl éther supplémentaire au mélange réactionnel pour sursaturer la matrice de cristallisation. Une suspension de germe est préparée dans un récipient de préparation et de distribution, puis ajoutée, sous pression, au mélange réactionnel. Le procédé permet d'obtenir du calcium d'atorvastatine cristallisé, de structure (I), à grande échelle industrielle.

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