Characterization and application of Borassus aethiopum (Arecaceae) shoot pregelatinized starch as binding agent in paracetamol tablets

Abstract

Aims: The study sought to characterize the physicochemical properties and assess the binding properties of pregelatinized starch (PGSb) derived from Borassus aethiopum shoot at various concentrations in paracetamol (PCM) tablet formulation. Methods and Materials: PGSb was obtained by suspending 100g of the native starch (NS) in 100ml of deionized water at 55°C for 10min. PGSb was characterized using different techniques and compared with a commercial brand of pregelatinized starch (PGSs). The compatibility of PGSb with PCM powder was evaluated using Fouriertransform infrared (FTIR) spectroscopy and differential scanning calorimetry (DSC) techniques. Three batches of PCM granules containing different concentrations of the PGSb as test binder were formulated and compared with two batches containing 1.78% polyvinylpyrrolidone and 1.78% NS as binder, respectively. Results: The evaluated parameters of PGSb were comparable to PGSs. PGSb had improved solubility, lower gelatinization temperature, and better hydration capacity properties compared to the NS. FTIR and DSC studies confirmed the modification of the NS and its compatibility with PCM powder. The tablets formulated were within acceptable limits for the parameters evaluated (tablet thickness, uniformity of weight, hardness, friability, disintegration, and dissolution profile) except the batch that contained NS as binder that failed uniformity of weight and friability tests. All the batches released more than 70% of the active drug at 30min. The dissolution study indicated that there were variations in the drug release profiles among tablets formulated with different binding agents. Conclusions: The findings of this study indicate that PGSb has desirable physicochemical and binding properties.