EVALUATION OF CARBOXYMETHYL MILLET STARCH AND PREGELATINIZED MILLET STARCH AS PHARMACEUTICAL EXCIPIENTS USING FACTORIAL EXPERIMENTAL DESIGNS

Objective: This study aimed to evaluate and optimize modified millet starches as pharmaceutical excipients in paracetamol tablet formulations, using factorial experimental designs to compare them against commonly used excipients in the industry. Methods: Paracetamol tablets containing Carboxymethyl Millet Starch (CMMS) and Pregelatinized Millet Starch (PGMS) were evaluated through official quality control tests such as hardness, friability, disintegration time, and dissolution profile. Compatibility studies were performed using Fourier-Transform Infrared Spectroscopy (FTIR). The formulations were optimized based on statistical analysis using design expert V8.0.6. Results: Tablets formulated with Carboxymethyl Millet Starch (CMMS) and Pregelatinized Millet Starch (PGMS) as excipients demonstrated a hardness range of 6.1–8.8 kg/cm² and disintegration times of 1.0–7.5 min. CMMS-based tablets showed slower drug release, reaching 80% release within 60 min. Statistical optimization indicated optimal binder concentrations of 6% for CMMS, resulting in a friability of 0.7%, hardness of 8.8 kg/cm², and disintegration time of 2.3 min, and 11% for PGMS, with a friability of 0.75%, hardness of 7.7 kg/cm², and disintegration time of 5.9 min. The optimized dissolution profile for PGMS formulations showed a similarity factor (f2) of 62, while CMMS tablets had an f2 value of 38 compared to Humadol. Conclusion: The modified millet starches, CMMS and PGMS, can serve as potential alternatives to conventional excipients in immediate-release formulations and show promising results in optimizing tablet properties.