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

机译:稳定的多单位药物制剂新型含有取代的苯并咪唑类。

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.
机译:适于填充硬明胶胶囊的稳定微粒制剂,其中含有苯并咪唑取代的盐或其盐,其特征在于含有1至50 mg的活性成分,球形的惰性核由惰性赋形剂组成的直径为600-1000微米的对称性,由以下三个连续的同心层覆盖而成:a)厚度为150-250微米的活性层,其中包含至少一种取代的苯并咪唑和各种药学上可接受的惰性赋形剂允许在小肠近端区域迅速分解制剂和活性成分的溶液/成分的合适条件; b)具有严格聚合性质的绝缘层,可溶于水,不含碱金属盐和/或碱土金属,且最小厚度为15微米; c)最小厚度为30微米的肠胃或肠溶层。可通过以下方法获得:将其制造的所有阶段都在带有Wurster流化床分离装置的干燥设备中进行,而在工艺过程的任何阶段均无需使用有机溶剂。

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