Abstract

FORMULATION & EVALUATION OF ORAL DISSOLVING FILM OR STRIP FOR MIGRAINE

Nutan Chandra, Pratibha Hanspal, Jatin Kumar Kewat and Devorat Singh*

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Abstract

Migraine is a neurological disorder, with severe headaches recurring and accompanied by nausea, vomiting, and sensitivity to light and sound. Sumatriptan, which is a selective agonist of serotonin receptors, is widely used for acute migraine attacks. However, conventional oral dosage forms of sumatriptan have certain shortcomings, including a delayed onset of action and poorer compliance from patients, especially when nausea and vomiting are the accompanying features. To decrease these drawbacks, the present study aims to formulate and evaluate an oral dissolving film (ODF) using sumatriptan for rapid dissolution, increased bioavailability, and patient convenience. Thus, the Oral Dissolving films were prepared by the solvent casting method using an appropriate film-forming polymer, such as hydroxypropyl methylcellulose (HPMC), with suitable plasticisers and other excipients for better flexibility, stability, and uniformity of the films. The prepared films were then examined concerning physicochemical characteristics such as thickness, folding endurance, surface pH, disintegration time, drug content uniformity, and in vitro drug release. Among the various formulations, the optimised batch exhibited rapid disintegration (within 30 s), uniform drug content, satisfactory mechanical strength, and maximum drug release within 10 min. The results indicate that the sumatriptan Oral Dissolving films that are prepared could be an alternative for traditional dosage forms.

Keywords: Migraine, Sumatriptan Succinate, Oral Dissolving Film, Mannitol.