Abstract
Hypertension, a common health issue, requires effective, patient-friendly treatments. Irbesartan, an Angiotensin II receptor antagonist, is frequently used to manage hypertension, but its low solubility restricts bioavailability. This study aimed to develop and optimize fast-dissolving tablets (FDTs) of Irbesartan by utilizing a natural polysaccharide from Glycyrrhiza glabra as a superdisintegrant to enhance wetting time, disintegration time, and drug release, thus improving patient compliance and therapeutic effectiveness. Glycyrrhiza glabra polysaccharide was isolated and evaluated for superdisintegrant potential in Irbesartan FDTs. A full factorial design was implemented to optimize formulation variables, including the concentrations of natural polysaccharide, sodium starch glycolate (SSG), and microcrystalline cellulose (MCC). The key quality attributes—wetting time, disintegration time, and drug release were assessed, and observed responses were compared with predictions to validate model accuracy. The optimized formulation exhibited a predicted wetting time of 43.71 seconds, drug release of 96.37%, and disintegration time of 76.83 seconds, while observed values were 45.62 seconds, 97.59%, and 79.28 seconds, respectively, yielding % predicted error values of 4.18%, 1.25%, and 3.09% all below 5.0%, confirming model reliability. This study successfully developed optimized Irbesartan FDTs with improved performance, demonstrating that Glycyrrhiza glabra polysaccharide is an effective superdisintegrant. Further, in vivo studies are recommended to confirm the optimized formulation’s therapeutic benefits in clinical settings.
Keywords: Factorial Design, Glycyrrhiza glabra natural polysaccharide (Mucilage), Hypertension, Irbesartan, Optimization.