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ABSTRACT
Starch modification can be achieved using physical and chemical means to improve its physicochemical characteristics and stability. These modifications enhance their potential applications, including their use in specialized drug delivery systems. This study aims to explore the excipient potential of cassava and potato starches modified via hydroxypropylation in diclofenac sodium tablet formulations. Native cassava and potato starches were subjected to initial pre-gelatinization before being hydroxypropylated (HP) using propylene oxide. The native and HP starch powders were characterized for their physicochemical properties (organoleptic, solubility, volume of sedimentation, water retention capacity, moisture sorption and freeze-thaw stability), bulk powder properties as well as high-resolution analyses using differential scanning calorimetry (DSC), Fourier transform infrared (FTIR) spectroscopy and scanning electron microscopy (SEM). Twelve batches of diclofenac sodium granules were prepared using varying amounts of the HP starches as the binder (mucilage) and filler (powder) using the wet granulation method. Drug-excipient interaction using FTIR and granule flow properties were investigated before compression into tablets. The formulated tablets were evaluated for weight uniformity, hardness, friability and in vitro drug release. Kinetics and mechanisms of drug release from the tablets were determined from the dissolution profiles of the tablets.
