Authors : Umesh Sanjay Gohad; S. B. Gondkar

Volume/Issue : Volume 10 - 2025, Issue 8 - August

Google Scholar : https://tinyurl.com/3nfxkt2f

Scribd : https://tinyurl.com/6bm6hhzm

DOI : https://doi.org/10.38124/ijisrt/25aug729

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Note : Google Scholar may take 30 to 40 days to display the article.

Abstract : 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.

Keywords : Nebivolol Hydrochloride; Mouth Dissolving Tablet; Factorial Design; Croscarmellose Sodium; Microcrystalline Cellulose.

References :

1. Chang RK, Guo X, Burnside BA, Couch RA. Fast-dissolving tablets. Pharm Tech. 2000;24(6):52–58.
2. Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol. 1998;50(4):375–382.
3. Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier JP, Piccerelle P. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int J Pharm. 2005;292(1-2):29–41.