Study of disintegrants and disintegration phenomena

Abstract

This study was centred on investigating the action of disintegrants and their roles in rapidly disintegrating tablets (RDTs) by visiometric, calorimetric, computational fluid dynamics (CFD) and quality by design (QbD) approaches. High-speed video imaging and solution calorimetry were used to elucidate the mechanisms of action of disintegrants. Disintegration test apparatus, particularly suitable for RDTs were developed. CFD was used to simulate different designs of the apparatus. The designed apparatus provided efficient and precise determination of very short disintegration times of RDTs. Functionality of disintegrants and their mixtures in RDTs were evaluated by a QbD approach. Disintegration time and hardness of RDTs were determined and modelled by using combined optimal design. Results demonstrated that the RDTs with desired disintegration times and hardness can be formulated by combining disintegrants at different compression pressures. In summary, findings of this study expanded the understanding of the properties of disintegrants and RDTs.