Assessment of Fractional Factorial Design for the Selection andScreening of Appropriate Components of a Self-nanoemulsifyingDrug Delivery System Formulation
Purpose: Recently, a self-nanoemulsifying drug delivery system (SNEDDS) has showngreat improvement in the enhancement of drug bioavailability. The selection of appropriatecompositions in the SNEDDS formulation is the fundamental step towards developing asuccessful formulation. This study sought to evaluate the effectiveness of fractional factorialdesign (FFD) in the selection and screening of a SNEDDS composition. Furthermore, the mostefficient FFD approach would be applied to the selection of SNEDDS components.Methods: The types of oil, surfactant, co-surfactant, and their concentrations were selected asfactors. 26 full factorial design (FD) (64 runs), 26-1 FFD (32 runs), 26-2 FFD (16 runs), and 26-3 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 potentialfor optimized formulation.Results: The results indicated that the patterns of 26 full FD and 26-1 for both main effects andinteractions were similar. 26-3 FFD lacked adequate precision when used for screening owing tothe limitation of design points. In addition, capryol, Tween 80, and transcutol P were selected tobe developed in a SNEDDS formulation with a particle size of 69.7 ± 5.3 nm along with a zetapotential of 33.4 ± 2.1 mV.Conclusion: Herein, 26-2 FFD was chosen as the most efficient and adequate design for theselection and screening of SNEDDS composition. The optimized formulation fulfilled therequirement of a quality target profile of a nanoemulsion.<br />