Application of SeDeM ODT Expert System in Formulation Development of Orodispersible Tablets of Antihyperlipidemic Agent

Background: Rosuvastatin calcium exhibits poor oral bioavailability due to extensive pre-systemic metabolism. Orodispersible tablets (ODTs) were prepared that disintegrate rapidly in oral mucosa thus preventing pre- systemic metabolism and enhancing the bioavailability of the drug. Objective: The objective of this study was to employ SeDeM ODT Expert system for characterization of excipients and formulation development of orodispersible tablets of rosuvastatin calcium. Materials and methods: ODTs were prepared by direct compression method using starlac as diluent and lycatab C and crospovidone as superdisintegrants in different concentrations. SeDeM ODT expert system was used on the excipients to predict their suitability for direct compression method. Results: SeDeM ODT expert system employed revealed that starlac, lycatab C and crospovidone were suitable and xylitol and sodium starch glycolate were unsuitable for direct compression method. FTIR studies revealed that there was no physico-chemical interaction between drug and other excipients. Preformulation studies were carried out to study the powder flow characteristics in order to achieve tablets of uniform weight. The values were well within the permissible limits. The tablets were subjected to post formulation evaluation parameters like thickness, weight variation, hardness, friability, wetting time, water absorption ratio, drug content uniformity, in vitro disintegration and in vitro dissolution studies. Conclusion: Suitability of the material for direct compression was successfully predicted using the SeDeM expert system. Formulations were developed based on the results of the SeDeM ODT expert system. Formulation F3 containing 15%w/w lycatab C as superdisintegrant exhibited minimum disintegration time and wetting time of 14.02±0.151s and 12.31±0.139s respectively and a maximum cumulative drug release of 93.06% at 15min. Hence, F3 formulation was the optimized formulation subjected to stability studies. Stability studies revealed that the formulation F3 was stable when stored at 40±2°C/75±5%RH for one month.