Fast Dissolving Sublingual Films of Zolmitriptan : A Novel treatment approach for Migraine Attacks

Abstract

Zolmitriptan, 5- Hydroxy tryptamine agonist is a new generation anti-migraine drug showing the oral bioavailability of only 40% as a result of hepatic first pass metabolism. The present research work is aimed to prepare sublingual dosage form of the Zolmitriptan with the purpose to achieve quick onset of action in management of severe migraine attacks. Fast dissolving sublingual films of Zolmitriptan were thus prepared by solvent casting method. Water soluble polymer hydroxyl propyl methyl cellulose E50 was used as film forming polymer. Polyethylene glycol 400 and propylene glycol were used as plasticizers. Sucralose was added as a sweetener and peppermint oil as flavoring agent. The formulations prepared were evaluated for their uniformity of weight, surface pH, folding endurance, disintegration time, mucoadhesion time, tensile strength, % elongation, content uniformity and % drug release. The FTIR studies showed no interaction between drug and polymer. From the observations of evaluation results, it was concluded that formulation F3 containing 10% PEG 400 and 3% PG for films prepared using HPMC E 50 was the best formulation among all other formulations. Films showed excellent stability for at least for 4 weeks when kept at RT as well as at 400C and 75% RH.