A SMART technology for continuously lyophilized orally disintegrating tablets (ODT)

Contact: Prof. Thomas De Beer, Ghent University, Department of Pharmaceutical analysis – thomas.debeer@ugent.be Driven by growing target populations for orally disintegrating tablets and by the regulatory pressure, it is our aim to develop, design, assembly and validate a SMART proof-of-concept technical prototype for the continuous lyophilization of ODT. Such continuous process would allow a more efficient, cheaper, greener and controllable ODT manufacturing method compared to traditional batch production systems, offering competitive advantages and business opportunities. Pharmaceutical freeze drying is a low-temperature drying process in which aqueous solutions of the ODT formulations are converted into tablets with desired properties (in terms of disintegration time, solid product structure, residual moisture content and mechanical strength) for distribution, storage and administration to patients. Similar to all manufacturing processes of drug products, conventional manufacturing of lyophilized ODT is generally accomplished using batch processing that is considered time-consuming, costly, non-flexible, lacking robust quality control and real-time release, and that has limited ODT formulation applicability. The presented SMART continuous freeze drying technology for ODT offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control, and a significant reduction of processing time, a substantial sustainability gain and an opportunity to manufacture new types of ODT (multilayer and mucoadhesive tablets, high dose and fixed dose combination tablets, oral biologics, personalized products) which cannot be processed using the current batch-wise technology.