Optimization of beta-carotene self-nanoemulsifying drug delivery system formula based on a low-energy method preparation and simplex lattice design

Beta-carotene is an antioxidant compound that benefits health by boosting immunity and preventing chronic diseases. However, beta-carotene has low solubility (practically insoluble in water) and bioavailability, so it will produce a poor beneficial effect. An alternative candidate that may overcome this problem is a self-nanoemulsifying drug delivery system (SNEDDS). SNEDDS can enhance the oral bioavailability of poorly soluble active compounds by increasing the solubility and stability of active compounds in oil droplets. This study aims to develop beta-carotene SNEDDS by determining the optimum composition of SNEDDS. The low-energy method and simplex lattice design (SLD) were combined to determine the optimum formula. Based on the results, the solubility of beta-carotene in sesame oil, polysorbate 80, and PEG 400 as components of SNEEDS were 0.455 mg/mL, 1.538 mg/mL, and 0.667 mg/mL, respectively. The optimum formula of beta-carotene SNEDDS had a mixing ratio of sesame oil and surfactant mixture in 1:15.2 (v/v), emulsification time of 38.48 ± 0.70 seconds, the droplet size of 13.13 ± 0.50 nm, and size distribution (PdI) of 0.133 ± 0.06. The optimum formula of beta-carotene SNEDDS had good stability in the artificial gastric fluid after 4 hours of incubation. Moreover, the optimum beta-carotene SNEDDS formula had high stability during storage at room temperature and 40oC ± 2oC/75RH±5RH. © 2024 Marmara University Press.