Fabrication and Evaluation of Medicated Chewing Gum of Antidepressant

Abstract

Background: Drug delivery via the oral route remains the most convenient approach; however, conventional solid dosage forms may be unsuitable for patients with swallowing difficulty or when water is unavailable. Medicated chewing gum (MCG) is a patient-centered platform that can enable saliva-mediated drug release during mastication and may improve acceptability and adherence. Objective: To formulate venlafaxine-loaded medicated chewing gum and evaluate its physicochemical quality attributes, drug–excipient compatibility, in-vitro release behavior in artificial saliva, and release kinetics. Methods: Three venlafaxine MCG formulations (37.5 mg/unit; ~1 g/unit) were prepared using a conventional melting and mixing method with varying drug incorporation sequences. Products were evaluated for weight variation, color, shape, stickiness, friability, and taste (healthy volunteers, n=5). Venlafaxine quantification was performed by UV spectrophotometry at 222 nm using a phosphate buffer calibration curve. In-vitro drug release was assessed in artificial saliva at 37 ± 2 °C with mechanical chewing simulation and sampling at 2, 5, 10, 15, 20, and 30 minutes. Release kinetics were modeled using zero-order, first-order, Higuchi, and Korsmeyer–Peppas approaches; compatibility was assessed by FTIR (400–4000 cm⁻¹). Results: All formulations demonstrated acceptable mechanical integrity and low friability (<1%) with consistent unit weights. In-vitro release exceeded 80% within 30 minutes across formulations, with formulation C showing the highest cumulative release (94.6 ± 2.4% at 30 minutes). Kinetic modeling supported diffusion-controlled (Fickian) release. FTIR spectra indicated no clinically meaningful drug–excipient incompatibility. Conclusion: Venlafaxine medicated chewing gum is feasible to formulate with acceptable quality attributes and rapid saliva-mediated drug release, supporting further in-vivo and clinical evaluation.