Stable drug form for oral administration with benzimidazole...

A - Human Necessities – 61 – K

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A61K 31/4439 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/50 (2006.01) A61K 31/196 (2006.01) A61K 47/38 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2258918

The invention relates to a stable drug form which is for oral administration and comprises: (a) a centre comprising an active ingredient selected from omeprazole, lansoprazole and pantoprazole, together with conventional auxiliary pharmaceutical ingredients, (b) an intermediate layer applied to the centre, and (c) an external layer which is resistant to gastric juice. The intermediate layer in (b) is in the form of a reactive layer comprising a polymeric layered material which is partly neutralised with alkalis, is resistant to gastric juice and has cation-exchange capacity. A process for the preparation of the stable drug form is also disclosed.

L'invention concerne une forme stable de médicament pour administration par voie orale, comprenant (a) un noyau renfermant un principe actif choisi à partir de l'omeprazole, du lansoprazole et du pantoprazole, conjointement avec des ingrédients pharmaceutiques auxiliaires usuels, (b) une couche intermédiaire appliquée sur le noyau, et (c) une couche externe résistant au suc gastrique. La couche intermédiaire en (b) se présente sous la forme d'une couche réactive renfermant un matériau stratifié polymère résistant au suc gastrique, partiellement neutralisé par des agents alcalins et à pouvoir d'échangeur cationique. L'invention concerne en outre un procédé de fabrication de ladite forme stable de médicament.

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