DESIGN AND OPTIMIZATION OF OLANZAPINE IMMEDIATE RELEASE TABLETS USING NATURAL SUPER DISINTEGRANTS BY RESPONSE SURFACE METHODOLOGY

Purpose: To formulate and evaluate Olanzapine immediate-release tablets using direct compression. Immediate release of drug from the dosage form is required for rapid onset of action and produce an immediate therapeutic effect. Method: Tablets were formulated using two different natural super disintegrants like Fenugreek and Isabghul and in combination by using Response Surface Methodology. The selected independent variables (Y1) Fenugreek and (Y2) Isabghul showed a significant effect on dependent variables, i.e., disintegration time (X1) and percentage drug release (X2). Drug and excipients compatibility studies were done by FTIR studies. Results: No significant drug-polymer interactions were observed in FTIR studies. The prepared tablets were evaluated for weight variation, friability, hardness, disintegration, and dissolution. A formulation containing 2% fenugreek and 5% isabghul was offered the relatively rapid release of Olanzapine when compared with other concentrations employed in this investigation. The formulation with 4.2% Fenugreek and 5% Isabghul was optimized, and the tablets were evaluated. Conclusion: The optimized formulation AOF14 showed the desired level of % CDR 98.43 at the end of 30 minutes, and their similarity factor (f2) was calculated with innovator whose value was found to be 97.52% at the end of 30 min.