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Twin-Screw Extruder in Pharmaceutical Industry: History, Working Principle, Applications, and Marketed Products: an In-depth Review
Journal of Pharmaceutical Innovation ( IF 2.7 ) Pub Date : 2020-11-23 , DOI: 10.1007/s12247-020-09520-7
Mori Dhaval , Shweta Sharma , Kiran Dudhat , Jayant Chavda

Twin-screw extruder (TSE), originally built and developed for plastic and rubber industries approximately 100 years ago, is now slowly but steadily gaining popularity in the pharmaceutical industry for manufacturing various dosage forms. TSE has proven to be a robust, multi-purpose, and environment-friendly instrument that has displayed the potential to revolutionize the manufacturing processes in the pharmaceutical industry. Having the facility to arrange process analytical tools at various segments, TSE has given an opportunity to the manufacturers for monitoring the quality of the product at critical stages of the manufacturing process and thus helped in shifting the focus of the pharmaceutical industry from “end product testing” to “building the quality at each stage.” The broad applicability of TSE in formulating ranges of dosage forms is been evident from the large numbers of research papers (more than 100) that have been published and marketed formulations that have entered the market in the last 10 years. The published research papers have demonstrated the applicability of TSE in preparing a variety of dosage forms and intermediates such as pharmaceutical salts, co-crystals, solid dispersions, transdermal gels, solid lipid nanoparticles, and ready to compressed granules.



中文翻译:

制药行业的双螺杆挤出机:历史,工作原理,应用和市售产品:深入综述

双螺杆挤出机(TSE)最初是为塑料和橡胶工业而开发和开发的,大约在100年前,现在在制药工业中逐渐但稳定地流行以制造各种剂型。TSE已被证明是一种坚固,多功能且环保的仪器,已显示出革新制药行业制造工艺的潜力。TSE拥有在各个领域安排过程分析工具的设施,从而为制造商提供了在制造过程的关键阶段监视产品质量的机会,从而帮助将制药行业的重点从“最终产品测试”转移到从“在每个阶段建立质量。TSE在剂型范围内的广泛适用性已从近十年来发表的大量研究论文和市场上销售的配方中得到了明显证明。已发表的研究论文证明了TSE在制备各种剂型和中间体(如药用盐,共晶体,固体分散体,透皮凝胶,固体脂质纳米颗粒和易于压制的颗粒)中的适用性。

更新日期:2020-11-25
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