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Development of next-generation dissolution models for pharmaceutical tablets

Project description

Modelling drug dissolution from tablets

Most pharmaceutical drugs exist in tablet form; however, predicting how a drug dissolves and is released in the body remains a persistent challenge. The dissolution profile depends on complex interactions between materials and manufacturing conditions and is central to assessing drug effectiveness. Poor control over these factors can lead to product recalls and undermine public trust. With the support of the Marie Skłodowska-Curie Actions programme, the ExplainDissolution project aims to revolutionise tablet formulation by developing an integrated, mechanistic modelling framework that predicts dissolution profiles with high accuracy. This tool is expected to reduce errors, cut development time, and improve the quality of medicines across Europe.

Objective

The European pharmaceutical market is worth more than 200 billion euros, and a significant share of it comes from tablets, the most popular dosage form used to treat hundreds of millions of patients. The in vitro dissolution profile is used to characterize how the drug is released from tablets, indicating their effectiveness. However, an incomplete understanding of the effect of material attributes and process parameters on the dissolution profile of tablets has been the source of various quality problems for decades. These include product recalls that undermine the trust of patients in medicines and cause major financial loss. Therefore, the purpose of this proposal is to integrate advanced mechanistic modelling techniques to construct a next-generation modelling framework that predicts the dissolution profile of tablets. This will be realized by combining continuum-based modelling of tablet compression with discrete element method simulation of disintegration and population balance equation-based description of drug dissolution. The integration of these techniques requires an interdisciplinary approach and has not been done before. The resulting integrated model will consider the properties of the tablet components and the geometry of the tablet press to predict how the drug will be released from the tablet following administration. By applying this technique, we estimate that the drug development cycle can become 4-5% shorter and many quality issues can be prevented. The Fellow will undertake a non-academic placement at Pion Inc. to access state-of-the-art dissolution testing equipment with in situ UV probes for real-time concentration measurement. During the project, the Fellow will gain familiarity with the mechanistic modelling techniques described above. Combining this new knowledge with his expertise in empirical dissolution modelling will enable the Fellow to pursue an ambitious research programme in the future, greatly enhancing his academic career.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-TMA-MSCA-PF-EF - HORIZON TMA MSCA Postdoctoral Fellowships - European Fellowships

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Call for proposal

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(opens in new window) HORIZON-MSCA-2024-PF-01

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Coordinator

UNIVERSITY OF LEICESTER
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 292 891,41
Address
UNIVERSITY ROAD
LE1 7RH Leicester
United Kingdom

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Region
East Midlands (England) Leicestershire, Rutland and Northamptonshire Leicester
Activity type
Higher or Secondary Education Establishments
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Total cost

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