Digital process design to define and deliver pharmaceutical particle attributes

Urwin, Stephanie J.; Chong, Magdalene W.S.; Li, Wei; McGinty, John; Mehta, Bhavik; Ottoboni, Sara; Pathan, Momina; Prasad, Elke; Robertson, Murray; McGowan, Mark; al-Attili, Mais; Gramadnikova, Ekaterina; Siddique, Mariam; Houson, Ian; Feilden, Helen; Benyahia, Brahim; Brown, Cameron J.; Halbert, Gavin W.; Johnston, Blair; Nordon, Alison; Price, Chris J.; Reilly, Chris D.; Sefcik, Jan; Florence, Alastair J.

doi:10.1016/j.cherd.2023.07.003

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Cited by 5 publications

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“…However, a more predictive model that accounts for all inherent complex phenomena, including spherical agglomeration, may be required. This may involve more advanced modeling and simulation strategies such as combined computational fluid dynamics, discrete element methodologies and population balance modeling, 28 which are beyond the scope of this study.…”

Section: Methodsmentioning

confidence: 99%

Production and Tuning of Spherical Agglomerates of Benzoic Acid Using Membrane Dispersion Systems

Lackowska,

Dragosavac,

Vladisavljevic

et al. 2023

Crystal Growth & Design

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Section: Methodsmentioning

confidence: 99%

Production and Tuning of Spherical Agglomerates of Benzoic Acid Using Membrane Dispersion Systems

Lackowska,

Dragosavac,

Vladisavljevic

et al. 2023

Crystal Growth & Design

Self Cite

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Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin

Brown,

McGinty,

Islam

et al. 2024

J Pharm Innov

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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.

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A framework for systematic crystal shape tuning – Case of Lovastatin's needle-shaped crystals

Li,

Hatcher,

Wilson

et al. 2024

Chemical Engineering Research and Design

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Digital process design to define and deliver pharmaceutical particle attributes

Cited by 5 publications

References 60 publications

Production and Tuning of Spherical Agglomerates of Benzoic Acid Using Membrane Dispersion Systems

Production and Tuning of Spherical Agglomerates of Benzoic Acid Using Membrane Dispersion Systems

Integrated Continuous Process Design for Crystallisation, Spherical Agglomeration, and Filtration of Lovastatin

A framework for systematic crystal shape tuning – Case of Lovastatin's needle-shaped crystals

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