Tabriz University of Medical Sciences Advanced Pharmaceutical Bulletin 2228-5881 9 4 2019 10 24 Assessment of Fractional Factorial Design for the Selection and Screening of Appropriate Components of a Self-nanoemulsifying Drug Delivery System Formulation 609 618 10.15171/apb.2019.070 EN Ilham Kuncahyo https://orcid.org/0000-0003-4075-693X Syaiful Choiri https://orcid.org/0000-0001-7750-6008 Achmad Fudholi Ronny Martien https://orcid.org/0000-0001-7291-6497 Abdul Rohman https://orcid.org/0000-0002-1141-7093 Journal Article 10.15171/apb.2019.070 2019 04 29 2019 08 13 Purpose: 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. Methods: The types of oil, surfactant, co-surfactant, and their concentrations were selected as factors. 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 potential for optimized formulation. Results: The results indicated that the patterns of 26 full FD and 26-1 for both main effects and interactions were similar. 26-3 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. Conclusion: Herein, 26-2 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.