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GRANULATE CONTAINING A PHARMACEUTICALLY ACTIVE SUBSTANCE AND ANEMULSIFIER AND METHOD FOR ITS MANUFACTURE

机译:包含药物活性物质和消脂剂的颗粒及其制造方法

摘要

One aspect of the present invention relates to a granulate having a volume weighted mean diameter of 1-200 m and containing: at least 0.1 wt. % of a pharmaceutically active substance; at least 10 wt. % of emulsifier 0-89.9 wt. % of a water-dispersible saccharide; the combination of the pharmaceutically active substance, the emulsifier and the water-dispersible saccharide together representing at least 60 wt. % of the granulate; wherein the granulate is monophasic or wherein the granulate comprises a dispersed phase containing the pharmaceutically active substance, said dispersed phase having a volume weighted mean diameter of less than 300 nm. Another aspect of the invention relates to a process for the preparation of said granulate containing a pharmaceutically active substance, which process employs.
机译:本发明的一个方面涉及一种颗粒,该颗粒的体积加权平均直径为1-200m,并且包含:至少0.1重量%。药物活性物质的百分比;至少10重量%乳化剂的0-89.9重量%。水分散性糖的百分比;药物活性物质,乳化剂和水分散性糖的组合在一起占至少60重量%。颗粒的百分比;其中颗粒是单相的,或者其中颗粒包含含有药物活性物质的分散相,所述分散相的体积加权平均直径小于300nm。本发明的另一方面涉及一种用于制备所述含有药物活性物质的颗粒的方法,该方法采用了该方法。

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