Pharm. Goedele Craye graduated as pharmacist in 2015 from Ghent University where she obtained her Master of Science in Pharmaceutical Care. For her Master’s thesis, which she completed at the University of Eastern Finland in Kuopio, she evaluated the characterization of amorphous and co-amorphous simvastatin formulations prepared by spray drying. In 2015, she started as a pharmacist in a community pharmacy. In 2021, she started her PhD research on high drug-loaded pellets to address the needs of patients with dysphagia.
Summary of Research Project
Multiparticulate pellet formulations offer more therapeutic advantages than conventional single-unit oral dosage forms and are interesting in the field of personalized medicine. In this project we will focus on the potential of high drug-loaded pellets to address the needs of patients with dysphagia. Extrusion-spheronisation is often used to produce pellets, especially when a high drug load is preferred. The amount of APIs in conventional pellets is limited to maximally 40% due to manufacturing challenges. A patented UGent technology demonstrated that using partially hydrolyzed polyvinylalcohol (PVA) as pelletization aid allows the production of pellets with a drug load of up to 90%. The first aim is to demonstrate the broad, generic applicability of this patented UGent technology as well as it potential for dysphagia patients. Therefore, we will generate an extensive dataset on the critical quality parameters of high-dosed PVA-based pellets prepared via extrusion-spheronization. The second aim is to identify an inert and generically applicable semi-solid administration matrix suitable for dosing of pellets. Finally, during clinical trials the acceptability of the placebo pellets administered via an inert semi-solid administration matrix will be tested in both healthy volunteers and in different dysphagia populations.
