Department of Pharmaceutical Analysis

Hannelien Everaert

Laboratory of Pharmaceutical Process Analytical TechnologyHannelien Everaert

Ottergemsesteenweg 460
B-9000 Gent (Belgium) 
Tel.: +32-9-264.80.56
Fax: +32-9-222.82.36
E-mail: Education: Pharmacist (Master in Industrial Pharmacy)

Continuous manufacturing of lyophilised orally disintegrating tablets

Orally disintegrating tablets (ODTs) produced by lyophilisation have a highly porous structure which leads to a very fast disintegration. The resulting liquid can be swallowed with high convenience without the need of extra water or shewing. ODTs are proven to be beneficial to patient compliance, especially with geriatric, paediatric or institutionalised patients that show a high incidence of dysphagia. Nevertheless, the current lyophilised ODT platforms have drawbacks. The use of gelatine or an emulsion system are disadvantageous for product quality and production efficiency. Moreover, the ODTs are manufactured using batch technology which includes several disadvantages such as within-batch and between-batch variability.

To counter the limitations and disadvantages of traditional batch lyophilisation, LPPAT developed an innovative technology for the continuous manufacturing of lyophilised ODTs. The purpose of my research project is to explore if the innovative continuous technology enables the production of new types of ODTs, using alternatives for gelatine. The production of high dose and fixed dose combination tablets will be investigated since they are in great demand due to growing target populations. Furthermore, a process optimisation strategy for the continuous freeze-drying process allowing to produce any formulation as efficient as possible therewith guaranteeing the desired ODT quality attributes will be developed. Here, the influence of different freezing and annealing conditions will be investigated, and the development of mechanistic models allowing the determination of the optimal process settings for primary and secondary drying are in scope.