Laure Descamps

Laboratory of Pharmaceutical Process Analytical TechnologyLaure Descamps

Ottergemsesteenweg 460
B-9000 Gent (Belgium) 
Tel.: +32-9-264.80.39
Fax: +32-9-222.82.36
E-mail: Education: Pharmacist (Master in Drug Development)

New models for efficiency improvement in pharmaceutical development

Tablets are still the major dosage form for pharmaceuticals on the market due to their ease of handling, convenient administration and low manufacturing costs. The current approach to formulate tablets of high quality, is based on trial and error which is expensive and time consuming. Quality by Design is a systematic scientific and risk based approach were quality is built in the product rather than tested afterwards and this reduces the cost and time. A possible tool to achieve this goal is a predictive platform where material attributes and process settings are linked to critical quality attributes. A major problem during manufacturing of tablets is adhesion of powder particles to punch surfaces: Sticking. This can lead to tablets with bad quality attributes, damaging of the punches and excessive cleaning. Sticking can lead to a waste of time and resources and is usually seen at the end of the development phase. Therefore, there is a need to predicting sticking early in the development phase.

The aim of this study is to build a predictive tabletability knowledge platform covering both formulation and design space by using a systematic approach. This with the focus on predicting tablet problems such as sticking. This project will focus on direct compression which is the most efficient way to produce tablets. 

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 on the time-to-market and thus resulting in an increased commercial lifecycle of a product.