Quality-by-design (QbD) approach has been applied to optimize lipid-based nanosystems formulations, including solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC) and nanoemulsions, besides being increasingly requested by regulatory authorities. Different mathematical models and statistical tests have been used, with similar conclusions regarding the parameters that influence the physical features of the resulting nanosystems. These include, variations in composition (e.g. lipid(s) and/or emulsifier(s)) and manufacturing parameters (e.g. emulsification rate and/or time, sonication amplitude and/or time, and homogenization pressure and/or cycles). These are critical parameters that influence nanoparticle/globule mean size, polydispersity index, zeta potential, drug encapsulation efficiency and in vitro drug release.

This review addresses the concepts and applications of QbD for the development of lipid-based nanosystems, reporting successful examples published in the last 2 years. Although, some limitations have been identified, it is expected that in the upcoming years the application of QbD in pharmaceutical development will be an established approach.

按设计质量（QbD）的方法已被用于优化基于脂质的纳米系统配方，包括固体脂质纳米颗粒（SLN），纳米结构脂质载体（NLC）和纳米乳剂，但监管机构对此的要求越来越高。已经使用了不同的数学模型和统计测试，关于影响所得纳米系统物理特征的参数的结论相似。其中包括成分（例如脂质和/或乳化剂）和制造参数（例如乳化速率和/或时间，超声振幅和/或时间以及均质压力和/或周期）。这些关键参数影响纳米粒子/小球的平均大小，多分散指数，ζ电势，药物包封效率和体外药物释放。

这篇综述阐述了QbD在基于脂质的纳米系统开发中的概念和应用，报告了过去两年中成功发表的实例。尽管已经确定了一些局限性，但是预计在未来几年中，QbD在药物开发中的应用将成为既定方法。