Assessment of Fractional Factorial Design for the Selection and Screening of Appropriate Components of a Self-nanoemulsifying Drug Delivery System Formulation.

Recently, a self-nanoemulsifying drug delivery system (SNEDDS) has shown great improvement in the enhancement of drug bioavailability. The selection of appropriate compositions in the SNEDDS formulation is the fundamental step towards developing a successful formulation. This study sought to evaluate the effectiveness of fractional factorial design (FFD) in the selection and screening of a SNEDDS composition. Furthermore, the most efficient FFD approach would be applied to the selection of SNEDDS components. The types of oil, surfactant, co-surfactant, and their concentrations were selected as factors. 2 full factorial design (FD) (64 runs), 2 FFD (32 runs), 2 FFD (16 runs), and 2 FFD (8 runs) were compared to the main effect contributions of each design. Ca-pitavastatin (Ca-PVT) was used as a drug model. Screening parameters, such as transmittance, emulsification time, and drug load, were selected as responses followed by particle size along with zeta potential for optimized formulation. The results indicated that the patterns of 2 full FD and 2 for both main effects and interactions were similar. 2 FFD lacked adequate precision when used for screening owing to the limitation of design points. In addition, capryol, Tween 80, and transcutol P were selected to be developed in a SNEDDS formulation with a particle size of 69.7± 5.3 nm along with a zeta potential of 33.4± 2.1 mV. Herein, 2 FFD was chosen as the most efficient and adequate design for the selection and screening of SNEDDS composition. The optimized formulation fulfilled the requirement of a quality target profile of a nanoemulsion.