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Bioenhanced Bilayer Sublingual Films Containing Antimigraine Drugs Using Microencapsulated Bioenhancer: in vivo Evaluation in Humans

Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar-125 001
(Haryana) India
*(e-mail:; Mobile: 77280 28075)
(Received: October 7, 2022; Accepted: November 10, 2022)


Long-lasting migraine pain is one of the most disabling neurological disorders and requires a quick
onset of action from the administered dosage form. This study aimed at providing sublingual
administration of the frequently used combination of NSAIDs and triptans in order to trigger their
action immediately by escaping the first pass metabolism. Sepitrap 80 and Sepitrap 4000 were used as
bioenhancers to accomplish the faster systemic delivery of therapeutic agents during migraine attacks.
In the present research, bilayer sublingual films were developed by joining the two loaded layers with
zolmitriptan and piroxicam, respectively. Approximately 92% of zolmitriptan was released from the formed
bilayer sublingual thin films within 3 min whereas 92% of piroxicam was released within 4.5 min from
the best formulation. Within 30 min of the commencement of the pharmacokinetic investigation, plasma
concentrations of the active component began to rise rapidly. When compared to commercial formulations,
the developed films had a greater AUC and Cmax with a shorter Tmax, indicating a faster trigger of
action and better bioavailability.
Key words : Bilayer films, sublingual films, pharmacokinetics, bioenhancers, migraine pain