Formulation And In-Vitro Evaluation Of Orally Disintegrating Tablet Of Granisetron Hydrochloride Using Novel Co-Processed Ludiflash

Abstract

The study aimed to develop an orally disintegrating tablet (ODT) containing 1 mg of Granisetron Hydrochloride. ODTs are gaining traction in the pharmaceutical sector due to their rapid tongue dispersion without water, benefiting from taste-masking properties. This proves advantageous, particularly for pediatric and geriatric patients who face difficulties swallowing conventional tablets, thus bolstering patient adherence. Granisetron hydrochloride, a selective 5-HT3 receptor antagonist, holds promise for managing chemotherapy-induced vomiting and nausea. Employing direct compression, nine distinct formulations of Granisetron hydrochloride mouth-dissolving tablets were crafted, incorporating innovative co-processed excipients: Ludiflash and super disintegrant sodium starch glycolate. Thorough evaluations of pre- and post-compression parameters revealed compliance with prescribed limits and favorable manufacturing flow properties. Friability values below 1% adhered to pharmacopoeial norms, and tablets exhibited robust mechanical integrity, reflecting hardness ranging from 2.46-4.24 kg/cm³. Uniform drug content (99.08-101.79% of claim) underscored consistency across formulations. Dissolution profiles, within acceptable ranges, were notable, with Formulation F9 demonstrating optimal release (91.99% at 5 min, 98.98% at 10 min, and 100.01% at 15 min). Notably, Formulation F6 excelled across aspects: in-vitro disintegration time (38 seconds), dissolution profile (87.99% at 5 min, 98.01% at 10 min, and 98.96% at 15 min), hardness (3.78 kg/cm³), Carr's index (20.92), and drug content (99.13%). In conclusion, this research successfully developed Granisetron Hydrochloride ODTs, enhancing patient compliance and palatability. Formulation F6 emerged as the preferred option, signifying its potential in addressing therapeutic challenges linked to bioavailability and taste.