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

Maniruzzaman Mohammed; Nokhodchi Ali

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

机译：通过热熔挤压和扩大的连续制造：监管事项

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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：目前，由于全球化，制药行业面临巨大挑战，以遵守监管事项。降低的专利生命和全面降低的新发现药物的盈利能力也强迫制药行业缩短了最大产量的药物开发时间。因此，通过热熔挤出（HME）的连续制造（CM）方法可以是实现这些目标的有希望的替代方案。 HME提供无溶剂绿色技术，具有易于扩展的过程。此外，CM与批处理流程相比提供了更好的产品质量保证，劳动力成本较少，发展时间较短。在本综述中，我们主要专注于CM的各个方面和HME的新兴应用，以弥合药物球体的当前制造空间。

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《Drug discovery today》 |2017年第2期|共12页
作者
Maniruzzaman Mohammed; Nokhodchi Ali;
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Univ Sussex Sch Life Sci Pharmaceut Res Lab Arundel Bldg Brighton BN1 9QJ E Sussex England;

Univ Sussex Sch Life Sci Pharmaceut Res Lab Arundel Bldg Brighton BN1 9QJ E Sussex England;

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正文语种 eng
中图分类药学;
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1. Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters [J] . Maniruzzaman Mohammed, Nokhodchi Ali Drug discovery today . 2017,第2期

机译：通过热熔挤压和扩大的连续制造：监管事项
2. Three Dimensional Printing by Hot-Melt Extrusion; New Era for Development of Personalized Medicines and Continuous Manufacturing of Pharmaceuticals [J] . Amit Chivate, Atul Garkal, Namdev Dhas, International Journal of Pharmaceutical Investigation . 2020,第3期

机译：用热熔挤出三维印刷;用于开发个性化药物的新时代，并持续制造药品
3. Integrated hot-melt extrusion - injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability [J] . Desai Parind M., Hogan Rachael C., Brancazio David, International Journal of Pharmaceutics . 2017,第1期

机译：集成热熔挤压 - 注塑连续平板制造平台：关键工艺参数的影响和制定属性对产品鲁棒性和尺寸稳定性的影响
4. Dimensional evaluation of additive manufactured polymer extrusion dies produced by continuous liquid interface production [C] . A. Turazza, A. Davoudinejad, M. Calaon, International Conference of the European Society for Precision Engineering and Nanotechnology . 2020

机译：添加剂制造的聚合物挤出模具的尺寸评估通过连续液体界面生产产生
5. Scale-Up of Extrusion Foaming Process for Manufacture of Polystyrene Foams Using Carbon Dioxide. [D] . Zhang, Hongtao. 2010

机译：扩大使用二氧化碳制造聚苯乙烯泡沫的挤出发泡工艺。
6. Pharmaceutical Applications of Hot-Melt Extrusion: Continuous Manufacturing Twin-Screw Granulations and 3D Printing [O] . Mohammed Maniruzzaman 2019

机译：热熔挤出的制药应用：连续制造双螺杆造粒和3D打印
7. Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters [O] . Maniruzzaman Mohammed, Nokhodchi Ali 2017

机译：通过热熔挤出和扩大规模进行连续制造：监管事宜

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

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