Time- specific delayed/pulsatile release dosage forms

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 31/519 (2006.01)

Patent

CA 2679210

A time specific delayed/pulsatile release dosage form which comprises: a core comprising at least one active principle and at least one disintegrating agent; a sealing layer surrounding the core essentially consisting of one or more water soluble or water insoluble pH independent polymers; an outer coating essentially consisting of one or more hydrophilic pH independent polymers; wherein: the at least one disintegrating agent is present in amounts of 1-20% byweight and the at least one active principle is present in amounts of 1-80% by weight, with respect to the core; the sealing layer accounts for 0.1-10% byweight, withrespect to the core; the outer coating accounts for 5-500 % byweight, withrespect to the core. These coated cores are capable of ensuring the immediate release of the active principle after a pre-defined lag time, independently of physiological pH variations occurring in the gastro-intestinal tract of mammals.

La présente invention concerne une forme de dosage à libération retardée/pulsatile en fonction du temps, comprenant : un noyau comprenant au moins un principe actif et au moins un délitant; une couche d'isolation entourant le noyau comprenant principalement un ou plusieurs polymères indépendants du pH solubles ou insolubles dans l'eau; un revêtement extérieur comprenant principalement un ou plusieurs polymères hydrophiles indépendants du pH; le(s) délitant(s) étant présent(s) en quantités comprises entre 1 et 20 % en poids et le(s) principe(s) actif(s) étant présent(s) en quantités comprises entre 1 et 80 % en poids, par rapport au noyau; la couche d'isolation réprésente entre 0,1 et 10 % en poids, par rapport au noyau; le revêtement extérieur représente entre 5 et 500 % en poids par rapport au noyau. Ces noyaux revêtus sont capables d'assurer la libération immédiate du principe actif après un temps de latence prédéfini, indépendamment des variations physiologiques du pH survenant dans le tractus gastro-intestinal des mammifères.

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