FORMULATION DEVELOPMENT AND EVALUATION OF DEFERASIROX DISPERSIBLE TABLETS

The main objective of this work was designed to Formulate and evaluate the Deferasirox Dispersible tablets. Model drug was characterized for Particle size distribution, bulk density and tapped density. The physical characterization reveals that API has very poor flow.Indicating that suitable granulation technology required for designing the dosage form. Model drug is related to BCS class II drug (low solubility and high permeability), to increase the solubility of model drug, need to incorporate solubility enhancers like surfactants. The excipients selected for final formulation were compatible with model drug. The finalized formula was optimized and the final composition contains the following excipients like Microcrystalline cellulose, Lactose mono hydrate, Cremophore, Povidone, Silicon dioxide, Crospovidone and Magnesium Stearate. The finalized formulation F19 had comparable dissolution profile to reference product. Finalized formulation F19 was stable when stored at 40 °C/ 75% RH for 1M, 2M and 3M min HDPE container. Key Words: Deferasirox, Dispersible tablets, BCS class II drug, Dissolution profile.