Formulation, development, and evaluation of orally disintegrating tablets of Atenolol

Abstract

Orally disintegrating tablets (ODTs) have emerged as a patient-friendly dosage form designed to improve compliance, especially in pediatric, geriatric, and dysphagic patients. Atenolol, a β₁-selective adrenergic blocker widely prescribed for hypertension, requires long-term administration and is therefore an ideal candidate for ODT formulation. The present study aimed to develop and optimize Atenolol ODTs using the direct compression method. Nine formulations (F1–F9) were prepared employing different superdisintegrants—crospovidone, croscarmellose sodium, and sodium starch glycolate—at varying concentrations. Preformulation studies confirmed drug purity, solubility, and compatibility with excipients. Prepared blends were evaluated for pre-compression parameters, while compressed tablets were assessed for post-compression characteristics, special ODT tests, in-vitro disintegration, dissolution behavior, and stability. All formulations complied with pharmacopeial limits. Among them, formulation F2 containing crospovidone exhibited the shortest disintegration time (~16 s) and maximum drug release (~99.8% within 30 min). Statistical analysis using one-way ANOVA demonstrated significant differences among formulations (p < 0.05). Accelerated stability studies confirmed formulation stability. The study concludes that Atenolol can be successfully formulated as an ODT with rapid disintegration, fast drug release, and acceptable mechanical strength, offering a promising alternative to conventional tablets.