Portier Christoph, Vervaet Chris, Vanhoorne Valérie
Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
Pharmaceutics. 2021 May 7;13(5):668. doi: 10.3390/pharmaceutics13050668.
Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in batch mode such as high shear granulation and fluid bed granulation, several equipment manufacturers have designed their own manufacturing setup. This has led to a steep increase in the research output in this field. However, most studies still focused on a single (often placebo) formulation, hence making it difficult to assess the general validity of the obtained results. Therefore, current review provides an overview of recent progress in the field of continuous twin screw wet granulation, with special focus on the importance of the formulation aspect and raw material properties. It gives practical guidance for novel and more experienced users of this technique and highlights some of the unmet needs that require further research.
连续双螺杆湿法制粒是过去十年间在制药行业和学术界备受关注的关键连续制造技术之一。与高剪切制粒和流化床制粒等间歇式湿法制粒技术相比，连续双螺杆湿法制粒具有显著优势，因此多家设备制造商设计了各自的制造装置。这使得该领域的研究成果急剧增加。然而，大多数研究仍集中在单一（通常为安慰剂）制剂上，因此难以评估所得结果的普遍有效性。因此，本综述概述了连续双螺杆湿法制粒领域的最新进展，特别关注制剂方面和原料特性的重要性。它为该技术的新用户和经验更丰富的用户提供了实用指导，并突出了一些需要进一步研究的未满足需求。
