Stable multi-unitary pharmaceutical preparations New containing substituted benzimidazoles that.
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机译:稳定的多单位药物制剂新型含有取代的苯并咪唑类。
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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.
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