Fermentation process for the preparation of pravastatin

Details Fermentation process for the preparation of pravastatin Fermentation process for the preparation of pravastatin

C - Chemistry, Metallurgy

12

P

C12P 7/62 (2006.01) A61K 31/215 (2006.01) C07C 67/00 (2006.01) C12P 17/06 (2006.01)

Patent

CA 2521276

The invention relates to a fermentation process for the preparation of substantially pure pravastatin. The process provides a method of producing pravastatin by microbial hydroxylation of compactin (ML-236B) by maintaining a concentration of compactin at not less than 300 ~g /ml during the process. The process produces substantially pure pravastatin with reduced related impurities. The invention also relates to pharmaceutical compositions that include the substantially pure pravastatin.

L'invention concerne un processus de fermentation pour la préparation de pravastatine sensiblement pure. Le processus permet d'obtenir un procédé de production de pravastatine par hydroxylation microbienne de compactine (ML-236B) tout en maintenant une concentration de compactine non inférieure à 300 µg/ml pendant le processus. Ce processus permet d'obtenir de la pravastatine sensiblement pure avec des impuretés associées réduites. L'invention concerne également des compositions pharmaceutiques qui contiennent la pravastatine sensiblement pure.

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