Formulation and Pharmacokinetic Study of Transdermal Patches Incorporated with Antiepileptic Drug

Objective: Rufinamide is an antiepileptic medication used to treat partial seizures and Lennox-Gastaut syndrome. In order to administer Rufinamide transdermally, this effort was meant to develop and test a smooth, manageable, matrix-type transdermal patch comprised of a straightforward and reasonably priced hydrophilic polymeric film. This technique was designed to address the constraints of its bioavailability, first-pass metabolism, and frequent dosage. Methods: The solvent casting process was used to make rufinamide transdermal patches, with HPMC E15 lV as the polymer, PEG-600 as the plasticizer, and Tween-40 as the permeability enhancer. The produced patches were tested for physicochemical, mechanical, chemical, and biological properties. For In vivo study, Wistar albino rats (230 g-250 g) were used. Analytical characterization included FTIR and DSC studies to evaluate drug-excipient compatibility, while UV spectrophotometry was used to determine the plasma drug concentration. Results: All patches were uniform, flexible, and exhibited acceptable physicochemical properties and adequate mechanical strength. Among the HPMC E15 lV-based patches, the drug release followed the order F2>F1>F3. Formulation F2 released 93.80% of the drug over 12 h. For the HPMC E15 lV-based patch (F2). Following oral suspension administration, the highest plasma drug concentration (Cmax) was 83.41 mcg/ml, and the time to peak (Tmax) was 4 h. Cmax and Tmax for the Rufinamide Transdermal patch (F2) were 74.77mcg/ml and 12 h, respectively. Tmax values were higher when rufinamide was given orally than when transdermal patches were placed to the skin of male Wistar rats. This variance in Tmax was induced by the barrier characteristics of the stratum corneum. Conclusion: Overall, the findings demonstrate that rufinamide transdermal patches can provide sustained drug delivery, depending on the polymer concentration, offering flexibility for clinical applications in the management of epilepsy.