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Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

机译:通过热熔挤出和扩大规模进行连续制造:监管事宜

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摘要

Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.
机译:当前,由于全球化,制药业在遵守法规方面面临着巨大的挑战。新发现药物的专利寿命缩短和总体利润下降,也迫使制药行业以最大的生产量缩短药物开发时间。因此,通过热熔挤出(HME)进行的连续制造(CM)工艺可能是实现这些目标的有希望的替代方法。 HME提供了无溶剂绿色技术,其工艺易于扩展。此外,与批处理相比,CM可提供更好的产品质量保证,并具有较少的人工成本和较短的开发时间。在这篇综述中,我们主要关注CM的各个方面以及HME的新兴应用,以弥合当前制药领域的制造差距。

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