Pharmaceuticals formulations and methods for modified...

A - Human Necessities – 61 – K

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A61K 31/366 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 9/32 (2006.01) A61K 31/401 (2006.01) A61K 45/06 (2006.01) A61P 3/06 (2006.01) A61P 9/00 (2006.01)

Patent

CA 2497832

The present invention is directed to compositions and methods of their use in treating, preventing, and/or managing one or more cardiovascular diseases using at least one poorly water-soluble statin, such as, for example, simvastatin and/or lovastatin. One method of the invention involves delaying release of the poorly water-soluble statin for a time sufficient to avoid metabolism of the statin at or near the gastrointestinal tract wall by the cytochrome P450 3A metabolic system, and releasing said statin in the ileum, colon, or both, with subsequent uptake into the hepatic portal vein and distribution to hepatocytes, wherein HMG-CoA reductase activity may be inhibited with minimal adverse drug interactions.

L'invention concerne des compositions et des procédés d'utilisation de celles-ci pour traiter, prévenir et/ou agir sur une ou plusieurs maladies cardio-vasculaires à l'aide d'au moins une statine peu soluble dans l'eau, telle que, par exemple, la simvastatine et/ou la lovastatine. Un procédé de l'invention comporte les étapes consistant à retarder la libération de la statine peu soluble dans l'eau pendant une durée suffisante pour éviter que la statine soit métabolisée par la paroi du tractus gastro-intestinal, ou à proximité de celle-ci, par le système métabolique du cytochrome P450 3A ; et à libérer la statine dans l'iléon et/ou le côlon, l'absorption ayant lieu ultérieurement dans la veine porte hépatique ainsi que la répartition dans les hépatocytes. L'invention permet d'inhiber l'activité de la HMG-CoA réductase et de réduire les interactions indésirables du médicament.

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