期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 496, 期 1, 页码 24-32出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2015.09.024
关键词
Twin screw granulation; In-line image analysis; Shewhart control charts; Continuous pharmaceutical manufacturing; Process analytical technology
资金
- EPSRC
- Doctoral Training Centre in Continuous Manufacturing and Crystallisation
- EPSRC [EP/I033459/1] Funding Source: UKRI
- Cancer Research UK [11526, 20740] Funding Source: researchfish
- Engineering and Physical Sciences Research Council [EP/I033459/1] Funding Source: researchfish
As twin screw granulation (TSG) provides one with many screw element options, characterization of each screw element is crucial in optimizing the screw configuration in order to obtain desired granule attributes. In this study, the performance of two different screw elements - distributive feed screws and kneading elements - was studied in an 11 mm TSG at different liquid-to-solid (L/S) ratios. The kneading element configuration was found to break large granules more efficiently, leading to narrower granule size distributions. While pharmaceutical industry shifts toward continuous manufacturing, inline monitoring and process control are gaining importance. Granules from an 11 mm TSG were analysed using the Eyecon (TM), a real-time high speed direct imaging system, which has been used to capture accurate particle size distribution and particle count. The size parameters and particle count were then assessed in terms of their ability to be a suitable control measure using the Shewhart control charts. d(10) and particle count were found to be good indicators of the change in L/S ratio. However, d(50) and d(90) did not reflect the change, due to their inherent variability even when the process is at steady state. (C) 2015 Elsevier B.V. All rights reserved.
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