Formulation and Evaluation of Oral Disintegrating Tablets of Enalapril Maleate Using Synthetic and Natural Superdisintegrants

Introduction: Oral disintegrating tablets (ODTs) improve patient compliance, especially in pediatric, geriatric, and dysphagic populations. Enalapril Maleate, an angiotensin-converting enzyme (ACE) inhibitor with poor water solubility, was selected as a model drug to evaluate the efficiency of synthetic and natural superdisintegrants in ODT formulations. Method: ODTs of Enalapril Maleate were prepared by direct compression using synthetic superdisintegrants (Croscarmellose Sodium, Sodium Starch Glycolate) and a natural disintegrant (Plantago ovata mucilage). Eight formulations were developed and evaluated for pre-compression and post-compression parameters, in vitro disintegration, dissolution, drug content uniformity studies. Results: All formulations complied with pharmacopoeial specifications. Among synthetic batches, CCS3 exhibited the shortest wetting time (8.55 s), disintegration time (17.64 s), and rapid dissolution (99.24% at 20 min). The natural formulation PO2 (20 mg Plantago ovata mucilage) showed comparable performance with disintegration time of ~12–14 s and nearly complete drug release (99.98% at 20 min). Conclusions: Both natural and synthetic superdisintegrants effectively produced ODTs of Enalapril Maleate with rapid disintegration and dissolution. Plantago ovata mucilage demonstrated comparable efficiency to synthetic disintegrants, supporting its potential as a cost-effective, sustainable, and eco-friendly alternative for ODT formulations.