Stable multi-unitary pharmaceutical preparations New containing substituted benzimidazoles that.

摘要

Preparations of stable microgranules suitable for filling hard gelatin capsules, containing the benzimidazole (s) substituted (s) or salts thereof, characterized by containing a quantity of ingredient (s) active (s) from 1 to 50 mg, an inert core of spherical symmetry with a diameter of 600-1000 microns constituted by inert excipients coated by three sequential concentric layers as follows: a) an active layer with a thickness of 150-250 microns containing at least one substituted benzimidazole and various pharmaceutically acceptable inert excipients , mixed in suitable conditions to allow rapid disintegration of the preparations and the solution / ingredient (s) active (s) in the proximal region of the small intestine proportions; b) an insulating layer of strictly polymeric nature, soluble in water, free of alkali metal salts and / or alkaline earth metal, with a minimum thickness of 15 microns; c) a gastroresistant or enteric layer of a minimum thickness of 30 microns .; obtainable by a process in which all stages of their manufacture take place in a drying equipment with Wurster fluid bed separation device, without using organic solvents in any stage of the technological process.