Abstract
Alfuzosin hydrochloride targets benign prostatic hypertrophy (BPH) in older men. This study aimed to produce matrix compositions with 24-hour extended-release tablets to reduce the requirement to provide three 2.5-mg Alfuzosin hydrochloride tablets daily. Wet granulation blended hydrophilic (Hydroxypropyl methylcellulose, HPMC K15M) and hydrophobic (Ethyl Cellulose, EC) polymers to develop the tablets. QbD employed a Randomised, Non-block, Central Composite Design using a quadratic model, response surface study style, and version 13.0. We methodically created eleven different formulas. A three-level-two factorial design was used, with independent variables HPMC K15 X1 and EC and X2 concentrations and dependent variables t25 and t90% drug release. Extended-release points were chosen based on % drug releases at 2, 4, 12, 16,20 and 24 hours. The formulation F8 displayed the highest drug release, approximately 99.95±1.84 percent within the specified time at 24 hours. The dissolution data were fitted into several release kinetics. Drug release was caused by the diffusion mechanism. The ANOVA data showed a regression coefficient value (R2) of 0.9502, suggesting a high level of excellence of fit. The calculated p-value of 0.002 falls below the significance threshold of p<0.05. It appears that the current model had a notable impact on the t90% drug release by utilizing a specific bio-degradable polymer. A combined polymers mixer extended Alfuzosin release over 24 hours, suggesting that the formulations are appropriate for a once-daily dosing. This approach optimizes the best, controlled release batch within the defined period, and F8 received the highest attractiveness rating of 1.00, highlighted in blue.
Keywords: Alfuzosin Hydrochloride, Alpha-1 Antagonist, Benign Prostatic Hyperplasia (BPH), Central Composite Design, Quality by Design (QbD).