Crystalline and pure modafinil, and process of preparing the...

C - Chemistry – Metallurgy – 07 – C

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C07C 315/06 (2006.01) C07C 315/02 (2006.01) C07C 317/44 (2006.01)

Patent

CA 2416792

The present invention provides an improved process for preparing modafinil, whereby it may be isolated in high purity by a single crystallization. The process produces modafinil free of sulphone products of over-oxidation and other byproducts. The invention further provides new crystalline Forms II-VI of modafinil and processes for preparing them. Each of the new forms is differentiated by a unique powder X-ray diffraction pattern. The invention further provides pharmaceutical compositions containing novel modafinil Forms II-IV and VI.

L'invention concerne un procédé amélioré de préparation de modafinil permettant d'isoler celui-ci en une pureté élevée par une seule cristallisation. Le procédé permet de produire du modafinil exempt de produits de sulfone de sur-oxydation et d'autres sous-produits. L'invention concerne en outre des nouvelles formes cristallines II-VI de modafinil et des procédés de préparation associés. Chaque nouvelle forme est différentiée par un motif unique de diffraction de rayon X sur poudre. L'invention concerne également des compositions pharmaceutiques renfermant des nouvelles formes II-IV et VI de modafinil.

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