Development of pitavastatin-loaded super-saturable self-nano emulsion: a continues screening and optimization approach using statistical technique

Selection of super-saturable self-nano emulsion (S-SNE) component and further development to obtain the design space which met the requirements is very challenging. The purpose of this study was to develop pitavastatin S-SNE formulation through prior screening and selection followed by a simultaneous determination of the design space using an experimental design approach. The fractional factorial design 2(6-2) was successfully applied to screen appropriate compositions in S-SNE, namely oil, surfactant, and co-surfactant. Not only the types of S-SNE composition but also the range of concentration of each composition was achieved. The selected type and range of S-SNE composition was further developed using D-Optimal design to obtain the design space region, which had narrow and desirable features of S-SNE. Capryol 90, Tween 80, and Transcutol P were selected as S-SNE components. The simultaneous development of S-SNE formulation using an experimental design approach was successfully applied to formulate robust and controlled S-SNE characteristics.