RIMEGEPANT EMBEDDED FAST DISSOLVING FILMS: A NOVEL APPROACH FOR ENHANCED MIGRAINE RELIEF

Abstract

Background: Rimegepant is a potent and selective antagonist of the calcitonin gene-related peptide (CGRP) receptor, used for the acute treatment of migraine. The objective of this study was to develop a patient-friendly, fast-dissolving film of Rimegepant for rapid drug release.

Methods: A 3² full factorial design was employed to optimize the formulation of Rimegepant fast-dissolving films. The films were prepared by solvent casting method using hydroxypropyl methylcellulose E100 (HPMC E100) as the film-forming polymer and honey as a natural plasticizer. Physicochemical properties, in vitro disintegration time, and drug release were evaluated.

Results: The optimized Rimegepant fast-dissolving films demonstrated a thickness of 0.24-0.29 mm, moisture content of 2.6-4.1%, pH of 5.5-6.5, drug content uniformity of 83.2-99.6%, disintegration time of 6.9-11.2 seconds, tensile strength of 5.3-9.5 g/cm², and folding endurance of 155-215. The in vitro drug release study showed that the optimized formulations (AD1 to AD9) achieved a drug release of 64.7-90.8% within 6 minutes, indicating rapid release of Rimegepant from the fast-dissolving films.

Conclusion: The developed Rimegepant fast-dissolving films exhibited desirable physicochemical properties, rapid disintegration, and high drug release. These films can serve as a promising alternative to conventional oral dosage forms, providing rapid relief to migraine patients and improving patient compliance. Further in vivo studies are warranted to evaluate the clinical efficacy of the fast-dissolving films.