Abstract

FORMULATION DEVELOPMENT AND STATISTICAL OPTIMIZATION OF TASTE-MASKED RAPID DISSOLVING FILMS FOR MIGRAINE THERAPY

Ajeet Kumar* and Dr. K. Saravanan

ABSTRACT

Aim and Objective: The development of fast-dissolving oral films offers a promising approach to improve patient compliance and enhance the therapeutic efficacy of Frovatriptan succinate. These films can potentially mask the bitter taste of the drug while providing rapid onset of action, which is crucial for effective migraine management. By utilizing RDF technology, the study aims to overcome the limitations of conventional oral dosage forms and provide a more convenient and patient-friendly delivery system for Frovatriptan succinate. Method: The optimized formulation was evaluated for various physicochemical parameters including thickness, folding endurance, disintegration time, and drug content uniformity. In vitro dissolution studies were conducted to assess the release profile of frovatriptan succinate from the rapidly disintegrating films. The stability of the formulated RDFs was investigated under different storage conditions to ensure their shelf life and maintain drug efficacy over time. Result: The result suggested that the formulation containing 20%w/w aspartame, 10%w/w xylitol and 5% citric acid was found to effectively obscure the bitter taste of drug with best overall acceptability. The same composition of aspartame, citric acid and xylitol was used for further optimization using DOE. Conclusion: The batches were numerically optimized to give a design space. The formulated rapid dissolving films were also evaluated for various physicochemical and mechanical properties, the result obtained of which were satisfying.

Keywords: Migraine, Rapid Dissolving Film, Solvent casting method, Stability studies, Frovatriptan succinate.