Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G1 1XQ, UK; Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC), University of Strathclyde, Glasgow G1 1RD, UK.
Department of Chemical Engineering, University College London, London WC1E 7JE, UK.
Int J Pharm. 2024 Sep 5;662:124528. doi: 10.1016/j.ijpharm.2024.124528. Epub 2024 Jul 26.
Over the past decade, continuous manufacturing has garnered significant attention in the pharmaceutical industry. Still, numerous continuous unit operations need developments, such as powder blending and feeding at low and high throughputs. Especially the continuous and consistent feeding of solid drug substances and excipients at low feed rates remains challenging. This study demonstrates a micro-feeder capable of feeding poorly-flowing pharmaceutical powders at low feed rates. The system performance was investigated using three grades of pharmaceutical powder: croscarmellose sodium (cohesive), magnesium stearate (very cohesive), and an active ingredient, paracetamol (non-flowing). The results show that the micro-feeder can continuously and consistently feed powders at low flow rates (<20 g/h) with low variability (<10 % for non-flowing materials and < 5 % for cohesive materials). Notably, the micro-feeder achieves these results without any feedback control and remains unaffected by refilling, making it a truly versatile and industry-relevant solution. The study's results demonstrate that this micro-feeder system effectively tackles the challenge of consistent and accurate powder feeding at low rates.
在过去的十年中，连续制造在制药行业引起了广泛关注。然而，许多连续的单元操作仍需要进一步发展，例如在低和高吞吐量下进行粉末混合和进料。特别是在低给料速率下，固体药物物质和赋形剂的连续和一致给料仍然具有挑战性。本研究展示了一种能够以低给料速率给料不良流动的药物粉末的微型给料器。使用三种药物粉末（交联羧甲基纤维素钠（粘性）、硬脂酸镁（非常粘性）和一种活性成分扑热息痛（非流动））研究了该系统的性能。结果表明，微型给料器可以以低流速（<20g/h）和低变异性（非流动材料<10%，粘性材料<5%）连续一致地给料。值得注意的是，微型给料器无需任何反馈控制即可实现这些结果，并且不受重新填充的影响，因此是一种真正通用且与行业相关的解决方案。该研究的结果表明，该微型给料器系统有效地解决了在低速率下进行一致和准确粉末给料的挑战。
