Taste-Masked orodispersible tablets of alfuzosin hydrochloride: response surface methodology (RSM) based approach for enhanced patient compliance in BPH management

Abstract

Alfuzosin hydrochloride, an α1-adrenergic antagonist used in the treatment of benign prostatic hyperplasia (BPH), was formulated as orodispersible tablets (ODTs) to improve patient compliance, particularly in geriatric patients with dysphagia. Tablets were prepared by direct compression using microcrystalline cellulose as a filler–binder, crospovidone as a superdisintegrant, magnesium stearate as a lubricant, and aspartame (2%) as a taste-masking agent.

Pre-compression studies confirmed satisfactory flow properties, compressibility, and drug–excipient compatibility. A Box–Behnken Design (BBD) was employed to evaluate the effects of crospovidone, microcrystalline cellulose, and magnesium stearate on friability, hardness, disintegration time, and drug release, enabling optimization of critical quality attributes. Numerical desirability optimization identified the optimized formulation containing 9.44% crospovidone, 49.49% microcrystalline cellulose, and 0.50% magnesium stearate, with an overall desirability of 0.997.

The optimized formulation showed rapid disintegration (10.72 sec), low friability (0.261%), adequate hardness (5.28 kg/cm²), and 99.21% drug release within initial 15 min. Taste evaluation using an Alpha MOS electronic tongue confirmed effective masking of the drug’s inherent bitterness and the study demonstrated the potential of optimized ODTs as a patient-friendly dosage form for effective BPH management.

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Imam, M., Gupta, N., Narayan, S., & Nagpal, K. (2026). Taste-Masked orodispersible tablets of alfuzosin hydrochloride: response surface methodology (RSM) based approach for enhanced patient compliance in BPH management. Pharmaceutical Development and Technology, 1–21. https://doi.org/10.1080/10837450.2026.2707519

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