Quality By Design Approach for Novel Drug Delivery Systems

QbD offers several unique benefits, including deep material and process understanding, flexibility change within the design space without post-approval, application of effective control strategies, and a more robust and reproducible product. The purpose of this chapter is to identify and highlight the fabrication of novel drug delivery systems under the implementation of the QbD approach. It provides a map of QbD, and its elements (material attributes, process parameters, quality attributes, risk assessment tools, and DoE). It also includes the most common novel drug delivery systems formulated using the QbD approach with examples. The knowledge mentioned in this chapter will facilitate understanding novel drug delivery systems using QbD and encourage increasing these novel systems to reach the market in the near future.