EP1108425B1 — New stable multi-unitary pharmaceutical preparations containing substituted benzimidazoles

USPTO Abstract

The present invention relates to new oral multi-unitary pharmaceutical preparations containing substituted benzimidazoles being inhibitors of H<+>, K<+>-ATPase (i.e. omeprazole, lansoprazole, pantoprazole, leminoprazole and pariprazole) or their pharmaceutically acceptable salts. Such pharmaceutical preparations are stable pellet preparations containing substituted benzimidazole(s) or their salts and they comprise a quantity of active ingredient of between I and 50 mg, an inert core of spherical symmetry with a diameter of 600 - 1000 mu m, constituted by inert excipients, coated with an active layer containing at least one substituted benzimidazole in the micronized form and various pharmaceutically acceptable inert excipients, mixed in suitable proportions in order to allow the disaggregation of the formulations and dissolution of the active ingredient(s) in an appropriate manner, coated in turn with an insulating layer of a strictly polymeric nature, soluble in water, free from alkaline and/or alkaline-earthy metallic salts, of a minimum thickness of 15 mu m, this layer being coated lastly with a gastroresistant or enteric layer of a minimum thickness of 30 mu m. This invention also refers to the process for the preparation of said pharmaceutical preparations.