RESUMEN
OBJECTIVE: To prepare enramycin self-microemulsifying drug delivery system (SMEDDS) and evaluate its quality. METHODS: The formulations of enramycin SMEDDS were screened by solubility experiment and self-emulsifying grading test. The formulation was optimized using Design Expert Software, taking particle size as dependent variable and the usage amoumts of oil, surfactant, and cosurfactant as independent variables. RESULTS: The optimized formulation of enramycin SMEDDS consisted of 20% ethyl oleate, 40% RH40, and 40% 1,2-propylene glycol. 1.0 g mixture contained 20 mg enramycin, which dispersed rapidly into water and the particle size of the formed emulsion was (27.81±0.79)nm. The enramycin SMEDDS dissolved by more than 90% within 10 min, much faster than that of enramycin API. The particle size and concentration of SMEDDS were stable at alternative temperature cycles (4 and 40℃) for 48 h, and the SMEDDS formulation had no effect on the bacteriostasis of enramycin. CONCLUSION: The quality of enramycin SMEDDS is stable. The system increases the dissolution of enramycin significantly and could be advantageous to improve the oral bioavailability of enramycin.