Hmg-coa reductase inhibitor extended release formulation

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/36 (2006.01) A61K 9/28 (2006.01)

Patent

CA 2390301

Controlled release oral solid dosage form for the reduction of serum cholesterol levels in humans include a drug comprising an alkyl ester of hydroxy substituted naphthalenes (e.g., lovastatin) and a controlled release carrier, such that the dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at about 10 to about 32 hours after oral administration on a once-a-day basis to human patients. The dosage form provides a therapeutically effective reduction in serum cholesterol levels. Methods of reducing serum cholesterol levels in humans are also disclosed.

L'invention concerne une forme posologique solide à libération lente administrée par voie orale destinée à diminuer les taux de cholestérol sérique chez un être humain. Cette forme posologique contient un médicament comprenant un ester d'alkyle de naphtalènes hydroxy substituées (par exemple, la lovastatine) et un véhicule à libération lente, de sorte que cette forme posologique requiert un temps moyen pour la concentration plasmatique maximale (T¿max?) du médicament qui a lieu entre environ 10 et environ 32 heures après l'administration orale à des patients humains à raison d'une prise une fois par jour. Cette forme posologique produit une diminution des taux de cholestérol sérique efficace du point de vue thérapeutique. L'invention concerne également des méthodes permettant de diminuer les taux de cholestérol sérique chez les êtres humains.

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