FORMULATION DEVELOPMENT AND EVALUATION OF DEFERASIROX DISPERSIBLE TABLETS
Journal Title: Mintage journal of pharmaceutical and medical sciences - Year 2017, Vol 6, Issue 6
Abstract
Objective: The main objective of this work was designed to Formulate and evaluate the Deferasirox Dispersible tablets. Methods: 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. Results: 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.The tablet parameters like weight variation, hardness, thickness etc. were evaluated for all batches. Physical parameters of tablet were found to be satisfactory in all the batches. In vitro dissolution studies were performed for the determination of optimized formulation. Conclusion: 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
Authors and Affiliations
s. saipriya, sasikanth kothamasu, manohar babu s
Keywords
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- EP ID EP436317
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