Abstract

Objective: This study aimed to develop and optimize fast-dissolving tablets (FDTs) of ondansetron hydrochloride (4 mg) using Plantago ovata mucilage as a natural superdisintegrant. The target formulation was designed to achieve a disintegration time of ?30 s, at least 85% drug release within 5 min, and a total tablet weight of 150 mg.

Methods: Nine formulations (F1-F9) were prepared by direct compression using varying concentrations of Plantago ovata mucilage (2-8% w/w), alone or in combination with crospovidone. Preformulation and compatibility studies were performed using Fourier-transform infrared (FTIR) spectroscopy and differential scanning calorimetry (DSC). Powder flow properties and the physicomechanical characteristics of the tablets were evaluated. In vitro disintegration time, wetting time, water absorption ratio, and dissolution behavior were assessed in simulated gastric fluid (pH 1.2) using a USP Type II dissolution apparatus at 37 ± 0.5 °C and 50 rpm. Dissolution data were fitted to zero-order, first-order, Higuchi, and Korsmeyer-Peppas kinetic models. A 3² factorial design was used for formulation optimization, and accelerated stability testing was conducted according to ICH Q1A(R2) guidelines.

Results: FTIR and DSC analyses indicated no obvious incompatibility between ondansetron hydrochloride and the formulation components. Formulation F5, containing 4% w/w Plantago ovata mucilage and 1% w/w crospovidone, demonstrated a disintegration time of 18.4 ± 1.2 s, a wetting time of 22.6 ± 1.5 s, a water absorption ratio of 88.3 ± 2.1%, and 94.7 ± 1.3% drug release within 5 min. The reported dissolution data showed the highest coefficient of determination for the first-order model (R² = 0.987), while the Korsmeyer-Peppas release exponent was 0.41. The formulations reportedly complied with the specified acceptance limits for weight variation, hardness, friability, and drug content uniformity. Following 90 days of accelerated storage at 40 ± 2 °C and 75 ± 5% relative humidity, no significant changes in drug content or dissolution behavior were reported, and the similarity factor (f?) remained above 85.

Conclusion: The optimized F5 formulation demonstrated rapid disintegration and drug release, supporting the potential of Plantago ovata mucilage as a natural superdisintegrant in ondansetron hydrochloride fast-dissolving tablets. The formulation may offer a convenient oral dosage form for patients who experience difficulty swallowing conventional tablets. Further confirmation using complete experimental data and validated stability results is required before drawing definitive conclusions regarding its performance and clinical applicability.