Formulation of Morinda Citrifolia L. Dried Extract in Tablet form by Direct Compression and Evaluation Using Design of Experiments

Abstract

Introduction: The work aims to prepare tablets of Morinda citrifolia hygroscopic dry powder extract by direct compression method and applying DoE 32 factorial design. Methods: All the statistical calculations and interpretation of the results were carried out using the Design Experiment 10 software version. Nine different formulation trials were conducted. Varying concentrations of binder (Ethyl cellulose) and disintegrating agents (Microcrystalline cellulose) are considered as two independent variables. Magnesium stearate, polyethene glycol-4000, sucrose and starch are used as bulking agents. The effect of the two variables on the hardness, time of disintegration and in vitro drug release were evaluated. Results: All the materials were compatible and found stable during the study. Among the nine different formulations, F9 formulation with binder and disintegrating in a 20:40 ratio showed 90.31% drug release. From the overlay plot, the F10 checkpoint batch was formulated and evaluated. F10 formulation was the most suitable formulation with a hardness of 5.2Kg/cm2, a disintegrating time of 31.6 min with 86.98% drug release. Conclusion: DoE 32 factorial design can be used to formulate tablets of Morinda citrifolia hygroscopic dry powder extract. The F10 formulation is considered as the optimized preparation. According to the Design of experiments, it is concluded that as the concentration of binder and disintegrating agent increases then the hardness, disintegration and percent drug release of the formulation also increases.