Abstract

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.

摘要

选择超饱和自纳米乳液（S-SNE）组分并进一步开发以获得满足要求的设计空间非常具有挑战性。本研究的目的是通过预先筛选和选择开发匹伐他汀 S-SNE 制剂，然后使用实验设计方法同时确定设计空间。部分析因设计 2 ^6-2已成功应用于筛选 S-SNE 中的适当成分，即油、表面活性剂和辅助表面活性剂。不仅实现了 S-SNE 组合物的类型，还实现了每种组合物的浓度范围。选定的 S-SNE 组合类型和范围使用 D-优化设计进一步开发以获得设计空间区域，其具有 S-SNE 的狭窄和理想特征。选择 Capryol 90、Tween 80 和 Transcutol P 作为 S-SNE 组分。使用实验设计方法同时开发 S-SNE 配方已成功应用于制定稳健且受控的 S-SNE 特性。