| People | Locations | Statistics |
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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
Use of terahertz-Raman spectroscopy to determine solubility of the crystalline active pharmaceutical ingredient in polymeric matrices during hot melt extrusion
Abstract
<p>Polymer-based amorphous solid dispersions (ASDs) comprise one of the most promising formulation strategies devised to improve the oral bioavailability of poorly water-soluble drugs. Exploitation of such systems in marketed products has been limited because of poor understanding of physical stability. The internal disordered structure and increased free energy provide a thermodynamic driving force for phase separation and recrystallization, which can compromise therapeutic efficacy and limit product shelf life. A primary concern in the development of stable ASDs is the solubility of the drug in the polymeric carrier, but there is a scarcity of reliable analytical techniques for its determination. In this work, terahertz (THz) Raman spectroscopy was introduced as a novel empirical approach to determine the saturated solubility of crystalline active pharmaceutical ingredient (API) in polymeric matrices directly during hot melt extrusion. The solubility of a model compound, paracetamol, in two polymer systems, Affinisol 15LV (HPMC) and Plasdone S630 (copovidone), was determined by monitoring the API structural phase transitions from crystalline to amorphous as an excess of crystalline drug dissolved in the polymeric matrix. THz-Raman results enabled construction of solubility phase diagrams and highlighted significant differences in the solubilization capacity of the two polymer systems. The maximum stable API-load was 20 wt % for Affinisol 15LV and 40 wt % for Plasdone S630. Differential scanning calorimetry and XRPD studies corroborated these results. This approach has demonstrated a novel capability to provide real-time API-polymer phase equilibria data in a manufacturing relevant environment and promising potential to predict solid-state solubility and physical stability of ASDs.</p>