A predictive tableting platform for direct compression processes.

Promovendus/a
Dhondt, Jens
Faculteit
Faculteit Farmaceutische Wetenschappen
Vakgroep
Vakgroep Farmaceutische Analyse
Curriculum
Master of Science in Drug Development, Universiteit Gent, 2015 Wetenschappen-Wiskunde A, Bisschoppelijk College Veurne, 2010
Academische graad
Doctor in de farmaceutische wetenschappen
Taal proefschrift
Engels
Vertaling titel
Een predictief tabletteer platform voor directe compressie processen.
Promotor(en)
Prof. dr. Thomas De Beer, UGent-Farmaceutische Analyse - Dr. Didier Klingeleers, Janssen Pharmaceutical companies of Johnson & Johnson
Examencommissie
Prof. dr. Stefaan De Smedt, UGent-Geneesmiddelenleer - Prof. dr. Valérie Vanhoorne, UGent-Geneesmiddelenleer - Prof. dr. Jan Verwaeren, UGent-Faculteit Bio-Ingenieurswetenschappen - Prof. dr. Vincent Mazel, Université de Bordeaux-Department of Science and Technology - MPhil Elaine Stone, Merlin Powder Characterisation - Dr. Geert Verreck, Janssen Pharmaceutical companies of Johnson & Johnson

Korte beschrijving

The efficient development of robust tableting processes is challenging due to the lack of mechanistic understanding on the impact of raw material properties and process parameters on tablet quality. The experimental determination of the effect of process and formulation parameters on tablet properties and subsequent optimization is labour-intensive, expensive and time-consuming. The combined use of an extensive raw material property database, process simulation tools and multivariate modelling allows more efficient and more optimized development of the direct compression (DC) process. In this thesis, key material attributes and in-process mechanical properties with a potential effect on tablet processability and tablet properties were identified. In a first step, an extensive characterization of 56 raw materials (over 100 material descriptors) and 26 formulation blends (31 material descriptors) was performed. These blends were subsequently compacted on a compaction simulator under multiple process conditions through a design of experiments (DoE) approach. A T-shaped partial least squares (T-PLS) model was established which correlates tablet quality attributes with process settings, raw material properties and blend ratios. During future development of the DC formulation and process for a new active pharmaceutical ingredient (API), this model can then be used to predict an optimal formulation composition and its optimal compaction process settings based on well-defined raw material characteristics and compaction tests to acquire the desired tablet quality profile. This study hence contributes to a better understanding of the impact of raw material properties and process settings on a DC process and final properties of the produced tablets, and provides a predictive platform allowing the efficient and more optimized development of a robust tableting process.

Praktisch

Datum
Woensdag 1 december 2021, 17:30
Locatie
Faculteit Farmaceutische Wetenschappen - Auditorium A - Claudius Galenus, Ottergemsesteenweg 460, 9000 Gent
Livestream
Volg online

Dear all, Please find above the Teams link to my PhD defence. For those who are not joining with a company-account, please fill in your full name in order to get access to the meeting. Kind regards, Jens