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Naji, M. |
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Motta, Antonella |
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Aletan, Dirar |
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Mohamed, Tarek |
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Ertürk, Emre |
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Taccardi, Nicola |
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Kononenko, Denys |
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Petrov, R. H. | Madrid |
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Alshaaer, Mazen | Brussels |
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Bih, L. |
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Casati, R. |
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Muller, Hermance |
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Kočí, Jan | Prague |
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Šuljagić, Marija |
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Kalteremidou, Kalliopi-Artemi | Brussels |
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Azam, Siraj |
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Ospanova, Alyiya |
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Blanpain, Bart |
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Ali, M. A. |
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Popa, V. |
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Rančić, M. |
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Ollier, Nadège |
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Azevedo, Nuno Monteiro |
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Landes, Michael |
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Rignanese, Gian-Marco |
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Florence, Alastair
University of Strathclyde
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (11/11 displayed)
- 2023Machine learning derived correlations for scale-up and technology transfer of primary nucleation kineticscitations
- 2021Heat transfer and residence time distribution in plug flow continuous oscillatory baffled crystalliserscitations
- 2019Use of terahertz-Raman spectroscopy to determine solubility of the crystalline active pharmaceutical ingredient in polymeric matrices during hot melt extrusioncitations
- 2019Developing mechanistic understanding of unconventional growth in pharmaceutical crystals using scanning electron microscopy, atomic force microscopy and time-of-flight secondary ion mass spectrometry
- 2018Enabling precision manufacturing of active pharmaceutical ingredientscitations
- 2017Solid oral dosage form manufacturing using injection moulding
- 2013A complementary experimental and computational study of loxapine succinate and its monohydratecitations
- 2013Chemical transformations of a crystalline coordination polymercitations
- 2012Polymer templating of supercooled indomethacin for polymorph selectioncitations
- 2011Different structural destinations: comparing reactions of [CuBr2(3-Brpy)(2)] crystals with HBr and HCl gascitations
- 2008A catemer-to-dimer structural transformation in cyheptamidecitations
Places of action
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article
Enabling precision manufacturing of active pharmaceutical ingredients
Abstract
Continuous manufacturing is widely used for the production of commodity products. Currently, it is attracting increasing interest from pharmaceutical industry and regulatory agencies as a means to provide a consistent supply of medicines. Crystallisation is a key operation in the isolation of the majority of pharmaceuticals and has been demonstrated in a continuous manner on a number of compounds using a range of processing technologies and scales. Whilst basic design principles for crystallisations and continuous processes are known, applying these in the context of rapid pharmaceutical process development with the associated constraints of speed to market and limited material availability is challenging. A systematic approach for continuous crystallisation process design is required to avoid the risk that decisions made on one aspect of the process conspire to make a later development step or steps, either for crystallisation or another unit operation, more difficult. In response to this industry challenge, an innovative system-wide approach to decision making has been developed to support rapid, systematic, and efficient continuous seeded cooling crystallisation process design. For continuous crystallisation, the goal is to develop and operate a robust, consistent process with tight control of particle attributes. Here, an innovative systems-based workflow is presented that addresses this challenge. The aim, methodology, key decisions and output at each at stage are defined and a case study is presented demonstrating the successful application of the workflow for the rapid design of processes to produce kilo quantities of product with distinct, specified attributes suited to the pharmaceutical development environment. This work concludes with a vision for future applications of workflows in continuous manufacturing development to achieve rapid performance based design of pharmaceuticals.