DEVELOPMENT OF ONDANSETRON HCL FAST DISINTEGRATING TABLETS USING 32 FULL FACTORIAL DESIGN

The present investigation was carried out to study the disintegrant property of Plantago ovata and Ocimum basilicum mucilages. The objective of the work was to develop Fast disintegrating tablets of Ondansetron HCl with a view to enhance patient compliances and dissolution rate by direct compression method using 3² full factorial design. Plantago ovata (2-10% w/w), Ocimum basilicum (4-8%w/w) mucilages were used as natural superdisintegrant and microcrystalline cellulose was used as diluent, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 11 s); the formulation containing 10% w/w Plantago ovata and 8% Ocimum basilicum mucilages  were found to be promising and tested for in vitro drug release pattern (in 0.1 N HCl), short-term stability (at 40º/75 % RH for 6 mo) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables (concentrations of Plantago ovata and Ocimum basilicum mucilages) on the in vitro dispersion time. The validity of the generated mathematical model was tested by preparing two extra-design check point formulations. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed two-fold faster drug release (t_50% 3.6 min) compared to the conventional commercial tablet formulation (t_50% 7 min). Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (p < 0.05).