Production, Characterization and Parametric Optimization of Dual Modified Cross Linked-Acetylated Potato Starch as Disintegrant for Tablet Formation

The objective of this study was to produce, characterize, and optimize modified potato starch derived from locally sourced potatoes, and to evaluate the physicochemical properties of native, cross-linked, acetylated, and dual cross-linked–acetylated potato starches as disintegrants for tablet formulation. Starch modification was performed through cross-linking and acetylation using sodium hexametaphosphate (SHMP) and acetic anhydride (AA) as modifying agents, respectively. Native and modified potato starches were characterized using Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), rapid visco analysis (RVA), and X-ray diffraction (XRD). The key modification parameters investigated included reaction temperature, reaction time, pH, concentration of the modifying agent (AA), and concentration of the NaOH catalyst. Based on preliminary experiments, reaction temperature (40, 60, and 80 °C), modifying agent concentration (10, 20, and 30%), and reaction time (40, 55, and 70 min) were selected as the primary variables. Process optimization for dual crosslinked-acetylated potato starch was carried out using response surface methodology based on a Box-Behnken experimental design, with acetyl content as the response variable. The optimized modification conditions were a reaction temperature of 40.22 °C, a reaction time of 69.85 min, and an acetic anhydride concentration of 21.92% (w/w). Under these optimized conditions, an acetyl content of 1.32 ± 0.077% was obtained. Tablets formulated using the dual crosslinked-acetylated potato starch as a disintegrant exhibited a disintegration time of 29.2 ± 0.29 min, a disintegration efficiency ratio of 500 ± 0.99 N min⁻¹, a crushing strength of 92.35 ± 0.86 N, and friability of 0.63 ± 0.08% (w/w). The modified starch was employed as a disintegrant in tablet formulations containing 10% paracetamol as the active pharmaceutical ingredient, magnesium stearate (10%) as a lubricant, and suitable fillers.