Formulation and In-vitro Evaluation of Orodispersible Sumatriptan Tablets: Implications for Rapid Therapeutic Delivery and Drug Safety

Abstract

The demand for Orodispersible Tablets (ODTs) has increased notably in recent years, particularly for pediatric and geriatric populations with swallowing difficulties. Sumatriptan, a selective serotonin 5 HT1B/1D receptor agonist, is widely used in the treatment of acute migraine; however, its oral bioavailability is limited (~15%) due to extensive first-pass metabolism. The present study aimed to formulate and evaluate orodispersible tablets of sumatriptan using the wet granulation method to enhance dissolution and improve therapeutic performance. The prepared formulations were evaluated for pre- and post-compression parameters, all of which were within pharmacopeial limits. Among the formulations, batch F5 demonstrated optimal performance, achieving 98% drug release within 15 minutes. FTIR and DSC analyses confirmed the absence of significant drug–excipient interactions, indicating formulation stability. The enhanced dissolution profile suggests the potential for faster onset of action, which is critical in acute migraine management. Such rapid-release formulations may improve therapeutic outcomes, enhance patient compliance, and potentially reduce the need for repeated dosing, thereby minimizing dose-related adverse effects and supporting safer, patient-centered therapy.