FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLETS OF VORTIOXETINE HBr

Vortioxetine, a well-established antidepressant for major depressive disorder, faces limitations in traditional formulations regarding patient compliance and rapid onset of action. Mouth dissolving tablets (MDTs) offer a patient-friendly alternative, particularly beneficial for drugs with narrow therapeutic windows. This study aimed to formulate and evaluate MDTs of vortioxetine using super disintegrants (Cros povidone, Croscarmellose sodium, Sodium starch glycolate), effervescent agents, and sublimation techniques. Twelve formulations (F1–F9) were prepared via direct compression, each containing 4 mg vortioxetine. The tablets were evaluated for physical properties (hardness, friability, disintegration time), drug content, dissolution profiles, and stability. Results indicated rapid disintegration (85% within 10 minutes). Stability studies over 45 days showed no significant changes in drug content or disintegration time. The optimized formulation (F9) demonstrated superior performance, with 98.5% drug release at 10 minutes. MDTs of vortioxetine present advantages such as enhanced patient compliance, ease of administration, and potential for faster therapeutic effects. This study underscores the potential of MDTs as a viable alternative to conventional tablets, particularly for patients with dysphagia. Further clinical studies are warranted to validate these findings.