A continuous micro-feeder for cohesive pharmaceutical materials.

Autor: Hou P; 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., Besenhard MO; Department of Chemical Engineering, University College London, London WC1E 7JE, UK., Halbert G; 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., Naftaly M; National Physical Laboratory, Teddington TW11 0LW, UK., Markl D; 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. Electronic address: daniel.markl@strath.ac.uk.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2024 Sep 05; Vol. 662, pp. 124528. Date of Electronic Publication: 2024 Jul 26.
DOI: 10.1016/j.ijpharm.2024.124528
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter Hou, Gavin Halbert and Daniel Markl have patent #PCT/GB2023/051291 pending to Assignee. Daniel Markl recently accepted to serve on the Editorial Board of IJP and IJP:X in 2024. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE