Brown, Cameron J;
Mcginty, John;
Islam, Muhammad T;
Rajoub, Nazer;
Arjmandi-Tash, Omid;
Ottoboni, Sara;
Shahid, Muhid;
... Florence, Alastair J; + view all
(2024)
Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin.
Journal of Pharmaceutical Innovation
, 19
(2)
, Article 9. 10.1007/s12247-024-09815-z.
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Abstract
Purpose: This work seeks to improve the particle processability of needle-like lovastatin crystals and develop a small-footprint continuous MicroFactory for its production. // Methods: General conditions for optimal spherical agglomeration of lovastatin crystals and subsequent product isolation are developed, first as batch processes, and then transferred to continuous MicroFactory operation. // Results: Methyl isobutyl ketone is a suitable bridging liquid for the spherical agglomeration of lovastatin. Practical challenges including coupling unit operations and solvent systems; mismatched flow rates and inconsistent suspension solid loading were resolved. The successful continuous production of lovastatin spherical agglomerates (D50 = 336 µm) was achieved. Spherical agglomeration increased the density of the bulk lovastatin powder and improved product flowability from poor to good, whilst maintaining lovastatin tablet performance. // Conclusion: A continuous, integrated MicroFactory for the crystallisation, spherical agglomeration, and filtration of lovastatin is presented with improved product particle processability. Up to 16,800 doses of lovastatin (60 mg) can be produced per day using a footprint of 23 m2.
| Type: | Article |
|---|---|
| Title: | Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1007/s12247-024-09815-z |
| Publisher version: | https://doi.org/10.1007/s12247-024-09815-z |
| Language: | English |
| Additional information: | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
| Keywords: | Continuous manufacturing; Process intensification; Pharmaceutical drug substance; Spherical agglomeration |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Chemical Engineering |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10209372 |
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