Crystalline hydrated dihydroxy open-acid simvastatin calcium...

C - Chemistry – Metallurgy – 07 – C

Patent

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Details

C07C 69/30 (2006.01) A61K 31/22 (2006.01) A61P 3/06 (2006.01) C07C 67/28 (2006.01) C07D 309/30 (2006.01) A61K 9/00 (2006.01)

Patent

CA 2365869

The instant invention provides methods and pharmaceutical compositions for inhibiting HMG-CoA reductase, as well as for treating and/or reducing the risk for diseases and conditions affected by inhibition of HMG-CoA reductase, comprising orally administering a therapeutically effective amount of a crystalline hydrated form of the calcium salt of dihydroxy open acid simvastatin to a patient in need of such treatment. Methods for making the calcium salt of dihydroxy open acid simvastatin are also provided.

L'invention concerne des procédés et des compositions pharmaceutiques pour l'inhibition de la HMG-CoA réductase, ainsi que pour le traitement et/ou la réduction du risque de maladies et d'états modifiés par l'inhibition de la HMG-CoA réductase. Lesdits procédés consistent à administrer par voie orale une dose efficace au plan thérapeutique sous une forme cristalline hydratée du sel de calcium de simvastatine d'acide ouvert en dihydroxy, à un patient ayant besoin dudit traitement. Les procédés de fabrication dudit sel de calcium de simvastatine d'acide ouvert en dihydroxy sont également décrits.

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