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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.
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.
| Original language | English |
|---|---|
| Article number | 9 |
| Number of pages | 19 |
| Journal | Journal of Pharmaceutical Innovation |
| Volume | 19 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 1 Mar 2024 |
Keywords
- continuous manufacturing
- process intensification
- pharmaceutical drug substance
- spherical agglomeration
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Data for: "Integrated continuous process design for crystallisation, spherical agglomeration, and filtration of lovastatin"
Brown, C. (Creator), McGinty, J. (Creator), Islam, T. (Creator), Rajoub, N. (Creator), Ottoboni, S. (Creator), Shahid, M. (Creator), Urwin, S. (Creator), Chong, M. (Creator), Prasad, E. (Creator), Spence, B. (Creator), Sefcik, J. (Supervisor), Robertson, J. (Supervisor), Smith, R. (Supervisor), Lister, J. D. (Supervisor), Price, C. J. (Supervisor), Nordon, A. (Supervisor), Adjiman, C. S. (Supervisor), Florence, A. (Supervisor), Arjmandi-Tash, O. (Creator), Seol Lee, Y. (Creator) & Papathanasiou, F. (Creator), University of Strathclyde, 27 Feb 2024
DOI: 10.15129/bab0578c-f3b8-459a-8dc1-270a60f4c770
Dataset