Preparation and evaluation of pomegranate seed oil nanoemulsions for delivery of fingolimod hydrochloride in multiple sclerosis treatment

Fingolimod hydrochloride is one of the available treatments for managing multiple sclerosis (MS), a leading cause of neurological disability among young adults. However, it may exhibit several side effects. This study aimed to develop a pomegranate seed oil nanoemulsion as a delivery system for fingolimod to enhance its therapeutic efficacy. A Box-Behnken experimental design was applied for optimization, with the oil proportion, poloxamer 188 concentration, and lecithin concentration selected as independent variables. Female C57BL/6 mice with experimental autoimmune encephalomyelitis (EAE) were treated intraperitoneally with fingolimod-loaded pomegranate seed oil nanoemulsion (FIN-PSO NE) containing 1 mg/kg of fingolimod daily for up to 28 days and subsequently evaluated. The optimized formulation, containing 30 % oil, 5 % poloxamer, and 2 % lecithin, showed a particle size of 231.26 ± 38.80 nm, a polydispersity index of 0.19 ± 0.06, and an entrapment efficiency of 99.57 ± 0.21 %. It also displayed a sustained drug release profile. SEM images revealed a smooth morphology and uniform size distribution. FTIR spectra indicated no interactions between the drug and other ingredients in the nanoemulsion. Additionally, this formulation alleviated neurological scores and reduced demyelination in EAE-induced mice. Consequently, it could be a promising candidate for MS treatment.