The College of Pharmacy discussed the PhD dissertation entitled “Lasmiditan Nano-emulsion-Based In-Situ Gel Intranasal Dosage Form: Formulation, Characterization, and In-vivo Study”. submitted by the by the PhD student assistant. Prof. Saba Abdulhadi Jaber and her supervisor Prof. Dr. Nawal Ayash Rajab, in the Pharmaceutics Department. This study aimed to improve LAS bioavailability via formulation as nano-emulsion-based in situ gel (NEIG) given intranasally to achieve rapid onset with a higher extent of drug absorption (higher bioavailability). Thirty-eight LAS nano-emulsions (NEs) were prepared using the spontaneous emulsification method with ultrasonication. Visual Characterization, Thermodynamic stability study, globule size, polydispersity index (PDI), drug content as well and in vitro release, all were measured to predict the optimum formulations that pass through the ex vivo studies. F15 (NE a), and F31(NE b) are the only successfully prepared NE formulas that were selected for the incorporation of different percentages of pH-sensitive in situ gelling polymer (Carbopol 934) to prepare NEIGs 1, 2, 3, 4, 5, and 6. The pH, gelation capacity, gel strength, and viscosity were predicted for the prepared NEIGs. The release (in-vitro) and the nasal permeation (ex-vivo) were determined for NEIG 2 and 5, then both were subjected to pharmacokinetics in vivo studies using 18 male rabbits weighing 1.8-2.0 kg. In conclusion, NEIG 2 and NEIG 5 are promising intranasal new formulas with improving bioavailability (rapid T max and higher C max) than the oral dosage form (AQS), although the selected optimum golden formula that will be ready for further clinical study is NEIG 2.
