Controlled release system and method for manufacturing the same

Details Controlled release system and method for manufacturing the same Controlled release system and method for manufacturing the same

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 31/496 (2006.01)

Patent

CA 2661613

The invention is directed to a pharmaceutical controlled release system for administration, particularly oral administration, of active substances with pH- dependent solubilities, comprising a) a core material containing or consisting of one or more pharmaceutically acceptable pH modifiers; b) optionally an insulating layer, c) a first layer containing or consisting of one or more pharmaceutically acceptable water-insoluble polymers; d) a second layer containing or consisting of at least one active substance having a pH-dependent solubility; e) a third layer containing or consisting of one or more pharmaceutically acceptable polymers having anionic or no ionic groups; and f) optionally a fourth layer, preferably in form of an outer coating layer. It is provided a pH-independent release profile of active substances having pH- dependent solubilities in vitro and vivo.

L'invention concerne un système de libération contrôlée de produits pharmaceutiques destiné à administrer, notamment par voie orale, des substances actives à solubilités dépendantes du pH, qui contiennent: a) un noyau contenant ou consistant en un ou plusieurs modificateurs de pH acceptables sur le plan pharmaceutique; b) éventuellement une couche isolante, c) une première couche contenant ou consistant en un ou plusieurs polymères insolubles dans l'eau acceptables sur le plan pharmaceutique; d) une deuxième couche contenant ou consistant en au moins une substance active possédant une solubilité dépendante du pH; e) une troisième couche contenant ou consistant en un ou plusieurs polymères acceptables sur le plan pharmaceutique qui possède des groupes anioniques ou non ioniques; et f) éventuellement une quatrième couche, de préférence sous forme de couche de revêtement externe. L'invention concerne également un profil de libération indépendant du pH des substances actives à solubilités dépendantes du pH in vitro et in vivo.

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