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Continuous Manufacturing of Amorphous Solid Dispersions using Hot Melt Extrusion based upon Quality by Design Principles: Understanding Critical Process Paramenters, Formulation Variables and Process Scale-up.

   School of Pharmacy

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  Prof Gavin Andrews  Applications accepted all year round  Self-Funded PhD Students Only

About the Project

Orally administered drugs represent the most patient acceptable drug delivery platforms on the market offering high levels of patient acceptability and compliance. Whilst most marketed formulations utilise the crystalline form of a drug compound, an increasing number of newly discovered drugs are falling into BCS class II/IV categories. This means that the bioavailability and hence therapeutic efficacy is limited by dissolution within the gastrointestinal fluids. Over the last decade there has been a renewed interest in solid dispersion technologies that utilise the amorphous form of a drug as a means of improving solubility within gastrointestinal fluids. In this time, the pharmaceutical industry has also moved towards continuous processing as a means of driving process efficiencies to produce high volume solid oral dosage forms in a highly controlled cost-efficient way. In this project, the PhD candidate will investigate the use of HME for the production of amorphous solid dispersions. The project will include the use statistical methods coupled with in-lab experiments to develop a deep understanding of solid dispersions and HME processing and apply quality risk management tools in a bid to enhance process capability/efficiency and to reduce product variability.

This project will provide extensive training in pharmaceutics relating to oral dosage form design. In addition to working at QUB, the student will have an opportunity to work closely with a large multinational pharmaceutical company to understand the complexities of drug product development and gain invaluable industrial experience

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