Development and Characterization of iron Chelator Sprinkle Granules

Abstract

The present study was aimed to formulate and evaluate immediate release sprinkle granules of Drug A as an oral iron chelating agent used for the treatment of chronic iron overload. Also Drug A is BCS class II drug, so it has poor solubility. So Drug A was prepared with improved solubility. The solubility was enhanced by infusing the pH modifier NaOH in the binder solution itself. Drug A IR sprinkle granules were prepared by wet granulation method using Fluidized Bed Processor. The suitable formulation was achieved by examining the cross-povidone, Poloxamer and Povidone levels. The results of this analysis defined the amount of those excipients to be used. Kolliwax HCO and Sodium Stearyl Fumarate were used in combination as a lubricant as they minimized dusting and increased flow property. Drug A IR sprinkle granules were further optimized with 23 factorial design with 3 centre points for extra confidence. The optimized formulation was thus obtained from this formulation been carried out. The stability parameters were applied to this formulation. Thus the final optimized batch was obtained.