Formulation Development and Evaluation of Nebivolol Hydrochloride Mouth Dissolving Tablets using Factorial Design

This study aimed to develop and evaluate mouth dissolving tablets (MDTs) of Nebivolol hydrochloride using a 32 factorial design approach. Nebivolol hydrochloride, a β1-selective adrenergic receptor blocker, was selected for its poor aqueous solubility and the need for rapid onset in hypertensive patients. Formulations were prepared by direct compression using Croscarmellose sodium and Microcrystalline cellulose as superdisintegrant and binder, respectively. Preformulation studies confirmed compatibility of drug and excipients. Nine formulations were developed and evaluated for pre-compression and post-compression parameters, including hardness, friability, drug content, disintegration time, and dissolution profile. The optimized formulation (F5) demonstrated a disintegration time of 18 seconds, hardness of 3.1 kg/cm2, and >95% drug release within 15 minutes. ANOVA results indicated that both independent variables significantly affected disintegration time and hardness. Stability studies confirmed formulation robustness over 3 months at accelerated conditions. The study concludes that factorial design is an effective approach for developing stable MDTs of Nebivolol hydrochloride with rapid disintegration and enhanced patient compliance.