Preparation and Characterization of Cetirizine Fast-Dissolving Tablets

Abstract

This research aimed to prepare and characterize the properties of cetirizine fast-dissolving tablets (FDTs) for improving patient compliance, especially among the elderly or individuals with swallowing difficulties. The effects of disintegrant type and concentration, including Kollidol®CL, Kollidol® CL-SF, and Explotab®, were evaluated on the characteristics of blank FDTs at concentrations of 5%, 7%, and 10% w/w. Additionally, the effect of compaction force was also investigated. The prepared tablets were evaluated regarding their properties in terms of thickness and hardness, weight variation, wetting time, and disintegration time (DT). The results revealed that the type and concentration of disintegrants significantly influenced tablet hardness, wetting time, and DT, with minimal impact on thickness and weight. Tablets formulated with 7% w/w of various disintegrants and compressed at a force of 12 kN demonstrated optimal physical properties and were selected for the preparation of cetirizine FDTs. Three formulations of cetirizine FDTs were prepared, with an average tablet weight of 307.34±2.57 mg. The weight fluctuation among the tablets was within 5%, adhering to the acceptability standards for the target weight. All FDT formulations exhibited complete wetting and full disintegration within 3 minutes. As a result, the prepared cetirizine FDTs conformed to the standards specified in the European Pharmacopoeia (EU). After one month of stability testing, all cetirizine FDTs retained satisfactory physical properties. However, further studies are required to evaluate their chemical stability. Future studies should focus on long-term stability and the evaluation of cetirizine FDT palatability in human volunteers.