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首页> 外文期刊>Hormone molecular biology and clinical investigation. >Dissolution improvement of an active pharmaceutical ingredient in a polymer melt by hot melt extrusion
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Dissolution improvement of an active pharmaceutical ingredient in a polymer melt by hot melt extrusion

机译：解散一个积极的改进聚合物熔体的药物成分热熔挤出

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摘要

Dissolution of poorly water-soluble active pharmaceutical ingredients (APIs) in polymeric melts plays an important role in the manufacturing of solid dispersions and solid solutions. The understanding of the dissolution is essential for selecting the processing equipment, the operating conditions, and the polymer excipients. The methodology presented in this work for ketoprofen (KTO) and polymer excipients serves as a screening process to select the best API-polymer formulation for hot melt extrusion (HME) to target a specific release profile. KTO dispersion within the polymer was characterized by differential scanning calorimetry (DSC), X-ray diffraction (XRD), and dissolution tests. Thermal characterization shows that a single phase amorphous solid solution (one glass transition temperature [Tg]) was achieved under the HME processing conditions and screw configuration; and with the combination of polymer excipients, an extended release profile of KTO was accomplished, releasing 100% of KTO in 24 h.
机译：溶解水溶性差的活跃在高分子药物成分(api)融化中发挥着重要作用制造固体分散体和固体解决方案。是必不可少的选择处理设备、操作条件,聚合物辅料。这项工作对于ketoprofen(遗传)和聚合物赋形剂作为筛选过程选择最好的热API-polymer配方熔体挤出(HME)针对一个特定的版本概要文件。以差示扫描量热法(DSC)、x射线衍射(XRD),解散测试。一个(一个单相非晶态固体的解决方案玻璃化转变温度(Tg))HME处理条件下和螺丝配置;高分子辅料,延长发布概要文件遗传是完成,释放出100%的遗传24小时。

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