Timed, sustained release multi-particulate dosage forms of...

A - Human Necessities – 61 – K

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A61K 9/62 (2006.01) A61K 9/50 (2006.01) A61K 31/138 (2006.01)

Patent

CA 2462637

A unit dosage form, such as a capsule or the like for delivering drugs into the body in a circadian release fashion, is comprising of one or more population of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a predesigned rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release cardiovascular drug delivery system is designed to provide a plasma concentration - time profile, which varies according to physiological need during the day, i.e., mimicking the circadian rhythm and severity manifestation of a cardiovascular disease, prodicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.

Forme posologique unitaire, telle qu'une capsule ou analogue, pour l'administration de médicaments dans le corps sur un mode de libération circadien, qui est constituée d'une ou plusieurs populations de particules contenant du propanolol (billes, pastilles, granules, etc.). Chaque population de particules possède un profil de libération rapide ou prolongée prédéterminé avec ou sans période de latence de 3 à 5 heures. Ce système d'administration de médicaments cardio-vasculaires à libération selon le rythme circadien est conçu pour permettre un profil concentration plasmique / temps qui varie selon les besoins physiologiques pendant la journée. Autrement dit, il imite le rythme circadien et la gravité / manifestation d'une maladie cardio-vasculaire, prédits sur la base de considérations pharmaco-cinétiques et pharmaco-dynamiques et sur des corrélations in vitro / in vivo.

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