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Pharmaceutics
Volume 14
Issue 5
10.3390/pharmaceutics14051058
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Article

Integrated Purification and Formulation of an Active Pharmaceutical Ingredient via Agitated Bed Crystallization and Fluidized Bed Processing

by
Michael W. Stocker
1,
Matthew J. Harding
1,2,
Valerio Todaro
3,
Anne Marie Healy
3 and
Steven Ferguson
1,2,4,5,*
1
School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland
2
I-Form, The SFI Research Centre for Advanced Manufacturing, School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland
3
SSPC, The SFI Research Centre for Pharmaceuticals, School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, D02 PN40 Dublin, Ireland
4
SSPC, The SFI Research Centre for Pharmaceuticals, School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland
5
National Institute for Bioprocess Research and Training, 24 Foster Avenue, Blackrock, Co., Belfield, A94 X099 Dublin, Ireland
*
Author to whom correspondence should be addressed.
Academic Editor: Nadia Passerini
Pharmaceutics 2022, 14(5), 1058; https://doi.org/10.3390/pharmaceutics14051058
Received: 24 March 2022 / Revised: 5 May 2022 / Accepted: 9 May 2022 / Published: 14 May 2022
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Abstract

Integrated API and drug product processing enable molecules with high clinical efficacy but poor physicochemical characteristics to be commercialized by direct co-processing with excipients to produce advanced multicomponent intermediates. Furthermore, developing isolation-free frameworks would enable end-to-end continuous processing of drugs. The aim of this work was to purify a model API (sodium ibuprofen) and impurity (ibuprofen ethyl ester) system and then directly process it into a solid-state formulation without isolating a solid API phase. Confined agitated bed crystallization is proposed to purify a liquid stream of impure API from 4% to 0.2% w/w impurity content through periodic or parallelized operations. This stream is combined with a polymer solution in an intermediary tank, enabling the API to be spray coated directly onto microcrystalline cellulose beads. The spray coating process was developed using a Design of Experiments approach, allowing control over the drug loading efficiency and the crystallinity of the API on the beads by altering the process parameters. The DoE study indicated that the solvent volume was the dominant factor controlling the drug loading efficiency, while a combination of factors influenced the crystallinity. The products from the fluidized bed are ideal for processing into final drug products and can subsequently be coated to control drug release. View Full-Text
Keywords: co-processing; crystallization; fluidized bed coating; formulation; isolation-free manufacturing; pharmaceuticals co-processing; crystallization; fluidized bed coating; formulation; isolation-free manufacturing; pharmaceuticals
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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MDPI and ACS Style

Stocker, M.W.; Harding, M.J.; Todaro, V.; Healy, A.M.; Ferguson, S. Integrated Purification and Formulation of an Active Pharmaceutical Ingredient via Agitated Bed Crystallization and Fluidized Bed Processing. Pharmaceutics 2022, 14, 1058. https://doi.org/10.3390/pharmaceutics14051058

AMA Style

Stocker MW, Harding MJ, Todaro V, Healy AM, Ferguson S. Integrated Purification and Formulation of an Active Pharmaceutical Ingredient via Agitated Bed Crystallization and Fluidized Bed Processing. Pharmaceutics. 2022; 14(5):1058. https://doi.org/10.3390/pharmaceutics14051058

Chicago/Turabian Style

Stocker, Michael W., Matthew J. Harding, Valerio Todaro, Anne Marie Healy, and Steven Ferguson. 2022. "Integrated Purification and Formulation of an Active Pharmaceutical Ingredient via Agitated Bed Crystallization and Fluidized Bed Processing" Pharmaceutics 14, no. 5: 1058. https://doi.org/10.3390/pharmaceutics14051058

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