Chapter 3 - Systematic Development of Nanocarriers Employing Quality by Design Paradigms

Abstract

Nanostructured pharmaceuticals are intricate drug formulations consisting of a plethora of active pharmaceutical ingredients with a multitude of functional and nonfunctional excipients for spatial and temporal delivery of drugs. Optimization of nanostructured drug delivery for attaining desired therapeutic efficacy is not a new phenomenon. For decades, the said objective has been accomplished using a traditional one variable at a time (OVAT) approach. Using this methodology, the solution of a specific problem can certainly be achieved, but attainment of the true optimal composition is never guaranteed. Besides, the traditional approaches are generally associated with multiple intricacies including utilization of a greater magnitude of time, money, and energy, inconduciveness to plug errors, unpredictability, and inability to reveal interactions among the factors too. Recently, the holistic Quality by Design (QbD)-based paradigm of Formulation by Design (FbD) has now been increasingly used in the development of optimized nanostructured drug delivery system (DDS) with complete understanding of the product(s) and process(es). The FbD approach embarks upon developing optimized nanostructured DDS employing the science and risk-based principles of QbD and multivariate approaches primarily, the Design of Experiments. This chapter describes the principles, methodology, and applications of FbD in the development of novel nanostructured DDS with special emphasis on the literature instances on them. In a nutshell, this chapter will act both as a ready reckoner and a catalyst in providing an impetus to venture into the FbD-based approach for optimization of nanostructured DDS.