DESIGN, DEVELOPMENT AND FORMULATION OF DISPERSIBLE TABLETS CONTAINING ANTIRETROVIRAL AS A DARUNAVIR BY DIRECT COMPRESSION USING 23 FULL FACTORIAL DESIGNS

The present investigation deals with preparation of Dispersible Tablets of Darunavir and to determine the influence of the certain excipients on physical properties of the tablets and solubility. Direct compression technique was used because of its ease of access and contains limited number of unit operations. A Superdisintegrant like Ac-di-sol, microcrystalline cellulose were screened to find the best formulation with good % drug release and disintegration values. Employing a 2 3 Full factorial design, the influence of three factors variables like Superdisintegrant concentration (Ac-di-sol), glidant (Aerosil) and Lubricant (Magnesium stearate) on the disintegration time and % drug release were determined. The drug excipient compatibility studies were performed by physical compatibility observation using stability chamber. The multiple linear regression analysis was used to find the effect of these variables on physical properties of final formulation. Finally, a optimized batch was considered to prove the validity of evolved method. Using the contour plot and cube plot, the effect of the independent variables on the responses was represented graphically. The stability studies of the optimized formula were carried as per ICH guidelines. Keywords: Ac-di-sol, 2 3 Full factorial design, Contour plot, Prediction profiler, disintegration,% drug release.