QBD DIRECTED FORMULATION AND EVALUATION OF MINI TABLETS COMBATING AZILSARTAN

The present study aims to design and optimize the Azilsartan Mini tablets formulation using the Quality by design (QbD) approach. A randomized two factorial experimental design was used to characterize the effect of the critical factors by varying the quantity of Hypromellose, Povidone PVP K and ethyl cellulose and assessed for their impacts on the critical quality attributes (responses), including friability, dissolution time, and content uniformity. The drug-excipients interaction of the formulation was investigated using FTIR and DSC, respectively. The accelerated stability study at 40 °C/75% relative humidity and real time stability study at 25 °C/60% relative humidity was performed. FTIR revealed an absence of any significant chemical interaction in solid state. The formulations exhibited acceptable friability (0.2 to 0.9%). The dissolution study of all eleven formulations ranged from 79 to 97%. The overall study showed that the optimum level of independent factors was found to be 4mg of hypomellose, 6 mg of ethyl cellulose and 4 mg povidone PVP K in each tablet. Accelerated stability studies showed the compendial acceptable hardness and friability. The application of QbD approach can help in the detailed understanding of the effect of CMAs and CPPs on the CQAs on Azilsartan final product.