The present investigation describes the influence of the hydroxypropyl methayl cellulose (HPMC) and different diluents on release behaviour and kinetics of Itopride HCL sustained release floating tablets using 32 full factorial design. The amounts of HPMC K100M (X1) and type of diluents (X2) were selected as independent variables and buoyancy lag time, drug release at 12hr (Q12), at 18hr (Q18) and T50% were selected as a dependent variable. Itopride HCL tablets were prepared by direct compression method using different proportions of HPMC K100M as release retardant with different diluents. The parameter optimized using 32 factorial designs. The tablets of all batches were evaluated for drug content, hardness, friability, weight variation and in vitro drug release profile. Different dissolution models were applied to drug release data in order to evaluate release mechanisms and kinetics. Regression analysis and response surface analysis were performed for dependent variables. Formulation FD2 was selected as an optimum formulation as it shows more similarity in dissolution profile with innovator profile (Similarity factor, f2= 56.58). It was observed that type of diluents and concentration of polymer had significant influence on BLT, T50%, and Q12 but no significant influence of diluents on Q18. Mathematical treatment of the in vitro drug release data suggests that, the drug release of all the formulations followed Higuchi model, the release exponent n < 0.5 indicate that drug diffuses through the polymeric matrix by a Fickian (case I) diffusion mechanism.
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