Multiparticulate pharmaceutical form with programmed and...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/54 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2333188

The invention concerns a mutliparticulate pharmaceutical form with delayed and timed release for starting to make the active principle available 4 to 8 hours after said pharmaceutical form has been ingested, then for gradually releasing the totality of the active principle within the following 8 to 20 hours. The invention is characterised in that it is free of organic acid and it is in the form of medicated spheroids consisting of a neutral spherical carrier comprising a first coating based on a mixture of at least a water soluble polymer and at least a water insoluble polymer wherein are uniformly distributed particles constituting an active principle, the whole comprising a second coating based on at least two independent pH polymers, having degrees of permeability with respect to different gastric and intestinal environments, optionally at least a dependent pH polymer, at least a plasticising agent and at least an inert filler distributed in said coating.

L'invention concerne une forme pharmaceutique multiparticulaire à libération retardée et pulsée, permettant d'obtenir le début de la mise à disposition du principe actif dans les 4 à 8 heures suivant l'ingestion de ladite forme pharmaceutique, puis la libération progressive de la totalité du principe actif dans les 8 à 20 heures suivantes, caractérisée par le fait qu'elle est exempte d'acide organique et qu'elle se présente sous la forme de sphéroïdes médicamenteux constitués d'un support sphérique neutre comportant un premier enrobage à base d'un mélange d'au moins un polymère hydrosoluble et d'au moins un polymère non hydrosoluble au sein duquel sont uniformément réparties des particules constitutives d'un principe actif, l'ensemble comportant un deuxième enrobage à base d'au moins deux polymères pH indépendants, présentant des degrés de perméabilité vis-à-vis des milieux gastrique et intestinal différents, éventuellement d'au moins un polymère pH dépendant, d'au moins un plastifiant et d'au moins une charge inerte uniformément répartie dans ledit enrobage.

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