Jens Dhondt

Laboratory of Pharmaceutical Process Analytical TechnologyJens Dhondt

Ottergemsesteenweg 460
B-9000 Gent (Belgium)
Tel.: +32-9-264.81.18
Fax: +32-9-222.82.36
Education: Pharmacist (Master in Drug Development)

Development of Predictive knowledge Platform on Tabletability

The most popular drug product dosage forms are tablets; this is preferred due to ease of mass production, storage, stability of the drug substance, handling and convenience to administer. However, development of robust tableting process in a timely manner is still challenging due to lacking a fundamental understanding of the tableting process and limited usage of sophisticated process simulation tools.

The aim of this study is to build a predictive tabletability knowledge platform covering both formulation and design space by using a systematic approach. Full characterization of materials under non-processing conditions will be used to investigate the correlation between powder characteristics and tablet quality attributes. In-process material properties will be obtained in a real-time manner by using the Compaction Simulator for which key settings will be identified. Scale-independent compaction profiles will be defined which can be used for future formulation developments. Knowledge will be acquired to further understand the relationship between small-scale and large-scale powder compaction. Using models will contribute to a better understanding of the impact of powder properties and process settings on the tableting process and tablet properties.

Potentially this study could deal with two main problems the pharmaceutical industry faces: less need for active pharmaceutical ingredient during the development process and a reduced time needed to develop a commercial viable tablet and its process. This could have a direct impact to the time-to-market and thus an increased commercial lifecycle of a product.