FORMULATION DEVELOPMENT AND EVALUATION OF TROPISETRON FAST DISSOLVING ORAL WAFERS

Abstract

Oral disintegrating wafers (ODWs) offer a novel approach to drug delivery, providing a user-friendly alternative for patients who have difficulty with traditional dosage forms. This research focused on the development and evaluation of Tropisetron-loaded fast-dissolving oral wafers, designed to address chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea. Tropisetron, a selective 5-HT3 receptor antagonist, was incorporated into oral wafers to enhance patient compliance and convenience through rapid disintegration and dissolution.

The wafers were formulated using the solvent casting method, with key ingredients including Crosscarmellose sodium, Cross Povidone, Methyl Paraben, Citric acid, and Aspartame. Various formulations (F1 to F8) were prepared and evaluated for physical and mechanical properties. The results revealed that formulation F7 exhibited the most favorable characteristics, including a rapid disintegration time of 31 seconds, high tensile strength of 0.712 kg/cm², and excellent drug content uniformity (93.65%). In-vitro dissolution studies showed that F7 released 94.02% of Tropisetron within 10 minutes, indicating effective and efficient drug delivery.

Stability studies of F7 demonstrated that the formulation maintained its quality and performance over three months, with minimal changes in disintegration time and drug release. The optimized F7 wafers provided a stable, effective, and user-friendly oral dosage form for Tropisetron, ensuring rapid therapeutic action and consistent drug delivery.

This study successfully developed Tropisetron-loaded fast-dissolving oral wafers with desirable properties for improved patient outcomes, aligning with the growing demand for convenient and effective antiemetic therapies.