ABSTRACT

The main objective of this study was to prepare and evaluate fast dissolving tablets of Levocetrizine dihydrochlori-de 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 pro-perties. 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 superdi-sintegrants 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 su-perdisintegrant among all; natural superdisintegrant like Hibiscus rosa sinensis Linn was also found to possess com-parable properties of ODT like other synthetic superdisintegrants. An accelerated stability study on optimized for-mulation was performed as per ICH guidelines. It was found to be stable, with insignificant changes in the hard-ness, disintegration time, and in-vitro drug release pattern.