Application of the quality by design concept in the development of lipid-based cubic liquid crystalline

It has become an industry consensus to take the concept of quality by design (QbD) as the basic principle of drug development design. On the basis of reviewing the design steps of pharmaceutical QbD, this paper deeply discusses the application of QbD in the development of lipid-based cubic liquid crystalline, and analyzes in detail the QbD elements in the design of lipid-based cubic liquid crystalline, such as quality target product profile, critical material attributes, risk assessment and factor screening, critical material attributes, critical process parameters, experimental design, design space and control strategy, etc. The purpose of this study is to deeply explore the integration and application of QbD concepts and provides a reference for the development of lipid-based cubic liquid crystalline preparations.