Abstract:
Development of nanomedicines has become an attractive strategy in the delivery of therapeutics to overcome the problems associated with conventional therapy especially for cancer, skin infections, tuberculosis, and other long-term disorders. Preparation of nanocarriers includes multiple constituents and multiple steps which need to be understood in-depth. It is expected that the application of quality by design (QbD) approach can overcome the existing issues related to nanoformulation development and can provide wider acceptability for regulatory agencies to form constructive guidelines for their approval. The objective of QbD in nanocarrier drug delivery is to derive meaningful product specifications based on safety, efficacy, and clinical performance. It helps in investigation of variable factors with respect to materials and process involved and ultimately enhances the process capability with minimum product variability. This book chapter has compiled various QbD components which can be easily implemented for preparation and optimization of robust nanoformulations.