Theme Leaders:

Prof. Anne Marie Healy
Trinity College Dublin
Dr Abina Crean
University College Cork

Medicine platform projects:

Project 3A: Optimisation and modelling of in vitro and in vivo performance of enabling formulations for poorly soluble drugs. Project 3B: Flexible manufacturing platforms and formulation approaches for personalised and age-appropriate medicines. Project 3C: Advanced material characterisation for solid dosage forms with a view to rational, predictive formulation design.

Overall Objective:

To optimise the development, production and use of safe and effective medicines focusing on poorly soluble drugs, personalized and age appropriate medicines, and rational formulation approaches with predictive performance.

Key Scientific Expertise:

Preformulation and formulation of solid dosage forms; amorphous materials; microneedles; solid state characterization; pharmaceutical processing; dissolution studies; dissolution modelling; in vivo animal (pig) model; in vitro-in vivo correlations.

Industrial Significance:

In the context of advancing formulation approaches we have identified three significant current challenges that need to be addressed, namely:

Poorly soluble drugs: It is estimated that more than 60% of new drug molecules display poor aqueous solubility. There is an on-going need for enabling formulations for such therapeutic agents which have suboptimal bioavailability.

Personalised and age-appropriate medicines: Translation of personalised medicines to large patient groups requires the development of novel formulation approaches to deliver tailored dosage for individual patient needs. By harnessing new and emerging technologies we will seek to provide age-appropriate formulations for paediatric and geriatric populations, where demand for such approaches is growing.

Rational formulation approaches with predictive performance: The implementation of predictive modelling approaches to reduce drug product development times, control the impact of material variability on manufacture, reduce drug product variability and support real time drug release is a key challenge, and can only be addressed through an improved understanding of how material and processing characteristics impact product performance.

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