ABSTRACT
Quality is the most crucial attribute for pharmaceutical product development, and it has become the thrust area for the regulatory bodies to approve safe, efficacious, stable, patient compliance and economical drug delivery systems. In this context, quality-by-design (QbD)-based formulation development is found to be an immerging technique and becoming the core of pharmaceutical companies. This computational approach has been explored for the development of various vesicular nanocarriers such as liposomes, niosomes, transferosomes, aquasomes and polymeric micelles. In this chapter, the fundamentals of designing, critical quality attributes, critical process parameters, exploitable design-of-experiments (DoE)-based formulation by design (FbD), and risk assessment, applicable to various vesicular nanocarriers, have been discussed. FbD will provide a widespread and significant knowledge and yield better vesicles without major regulatory problems by a thorough understanding of the root cause (such as critical process variables, material aspects and critical quality attributes) which impacts on quality. Nevertheless, there is inadequate understanding and major concerns regarding the execution of FbD principles in the area of vesicular systems. Different elucidations are mentioned to justify how the FbD can be a valuable approach to overcome these limitations. This chapter is a good assemblage of information and guides scientists engaged in the development of vesicular nanocarriers.
