Innovative Approach of Rapid Dissolving Tablet for Hypertensive Therapy using Box Behnken Design

Abstract

The development of oral disintegrating tablets (ODTs) for antihypertensive drugs represents a promising approach to improve patient adherence, especially for those with difficulty swallowing traditional tablets. This study focuses on the formulation and optimization of hydrochlorothiazide (HCTZ) ODT using Box-Behnken design (BBD) for process optimization. The research employs excipients such as fenugreek seed powder as a superdisintegrant, Locust bean gum and banana powder as binders, corn starch as a glidant, magnesium stearate as a lubricant, microcrystalline cellulose (MCC) as a filler, and aspartame as a sweetener. Additionally, polyethylene glycol 4000 (PEG-4000) is used as a solubility enhancer through solid dispersion techniques. The BBD method investigates the effect of concentrations of fenugreek seeds, robusta gum and PEG-4000 on tablet properties such as disintegration time, dissolution rate, hardness, friability etc. The optimized formulation exhibits rapid disintegration (within 30 seconds), improved dissolution profile and enhanced bioavailability of hydrochlorothiazide due to the solubility-enhancing properties of PEG-4000. The results indicate that the combination of excipients and solid-phase dispersion methods can significantly improve the efficacy of ODT, providing a potential solution to improve therapeutic outcomes in the treatment of Hypertension.