Development of Paracetamol Tablet Formulations Using Phosphate-Pregelatinized Cornstarch as Binders
Abstract
Starch is a widely used excipient in tablet formulations, particularly as a binder. However, its binding capacity often requires enhancement through physical or chemical modification. This study aimed to develop and optimize paracetamol tablet formulations using phosphate-pregelatinized starch derived from Zea mays L. as a binder. Starch was modified using sodium hydrogen phosphate (Na₂HPO₄) at concentrations of 0.25%, 0.30%, and 0.35%, and subsequently characterized. Five tablet formulations were prepared via wet granulation using 0.3% phosphate-pregelatinized starch at varying concentrations (3%–7%). The modified starch met pharmacopeial specifications, with the highest viscosity observed at 0.30% Na₂HPO₄. The formulation containing 7% phosphate-pregelatinized starch exhibited optimal tablet characteristics: diameter 13 mm, thickness 0.5 mm, hardness 5.8 kg, disintegration time 1.36 minutes, friability 0.5%, drug content 101.86%, weight uniformity 711.5 mg, and dissolution rate 99.28%. These findings demonstrate that Zea mays starch can be effectively modified into phosphate-pregelatinized form and used as a functional binder in tablet formulations. Moreover, the enhanced solubility of the modified starch may improve the dissolution of paracetamol as a model drug.
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