Comparative evaluation of natural and synthetic superdisintegrants in the formulation of fast dissolving tablets

Abstract

The main objective of this study was to prepare and evaluate fast dissolving tablets of Levocetrizine dihydrochloride with synthetic and natural superdisintegrants. Various formulations were prepared by direct compression using different concentrations of natural superdisintegrant i.e. isolated mucilage Hibiscus rosa sinensis Linn and synthetic superdisintegrants namely Kyron T-314, croscarmellose sodium and crospovidone. The compatibility studies between drug and excipients were carried out using FTIR spectroscopy. The blend was evaluated for additive properties. The tablets were evaluated for physical properties and in vitro drug release. From this study formulation containing Kyron T-314(2.4%) was found to possess better disintegration time (30 sec), water absorption ratio (95), and wetting time (34 sec). The in vitro dissolution of Kyron T-314 was found to have comparable release with other formulations of ODT with Hibiscus rosa sinensis Linn mucilage powder and croscarmellose sodium. natural superdisintegrants like Hibiscus rosa sinensis Linn mucilage powder showed better disintegrating property than the most widely used synthetic superdisintegrants like croscarmellose sodium. But Kyron T-314 was found to be better superdisintegrant among all; natural superdisintegrant like Hibiscus rosa sinensis Linn was also found to possess comparable properties of ODT like other synthetic superdisintegrants. An accelerated stability study on optimized formulation was performed as per ICH guidelines. It was found to be stable, with insignificant changes in the hardness, disintegration time, and in-vitro drug release pattern.