Development, Optimization, and Characterization of Donepezil Hydrochloride-loaded Emulsomes with Nigella Sativa Oil for the Treatment of Alzheimer's Disease.

INTRODUCTION: Alzheimer's disease is a progressive neurodegenerative disorder where conventional oral delivery of donepezil hydrochloride is limited by poor bioavailability and restricted brain access due to the blood-brain barrier. This study aims to develop an alternative nanocarrier-based delivery system to enhance therapeutic efficacy. METHOD: Trestearin, phosphatidylcholine, and cholesterol formed a solid lipid core that was used to make emulsomes. TEM was used to characterize emulsomes, while FTIR spectroscopy was used for compatibility tests. The formulation was optimized using the 3-factor, 3-level Central Composite Design. RESULT: The optimized emulsome formulation demonstrated a stable formulation with a mean particle diameter of 124 ± 3.25 nm, an entrapment efficiency of 74 ± 0.67%, a PDI of 0.209 ± 0.03, with a zeta potential of -0.130 mV. In vitro release study demonstrated a consistent drugrelease pattern, with 84 ± 1.24% of the medication released during the investigation. DISCUSSION: Based on insights from the thesis, emulsomes incorporating Nigella sativa oil show enhanced neuroprotective potential due to the antioxidant and anti-inflammatory actions of thymoquinone. The intranasal route further supports improved brain targeting by bypassing the blood-brain barrier. The consistency of particle size, strong entrapment efficiency, and sustained drug release align with the reported advantages of emulsome-based formulations discussed in the thesis, reinforcing their promise as an effective approach for Alzheimer's treatment. CONCLUSION: The central composite design optimization ensures a stable and effective delivery system for the donepezil hydrochloride-loaded emulsomes containing Nigella sativa oil with great potential for novel drug delivery in Alzheimer's disease.