SeDeM ODT Expert System in FormulationDevelopment of Orodispersible Tablets – PDF Download

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 crospovi-
done 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. Prefor- mulation studies were carried out to study the powder ow 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.

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