Nanomedicine development: Methods, scale-up, and challenges

Abstract

Nanomedicine development is a multimodal process. It involves aspects like selection of an appropriate method of preparation and the propensity of scaling up the method of preparation for manufacture of the nanomedicine at the industrial scale. There are also multiple challenges standing between lab-scale production and making it available for patients in need. There are several nanoscale-based products available on the market, yet there is a huge gap between publications claiming the successful production of nanomedicine and the actual number reaching regulatory bodies for approval. This reason behind this gap needs to be addressed to increase the number of nano- and target-specific formulations. This chapter discusses the fundamentals of methods of nanomedicine preparation, with details on their scale-up and the challenges faced during nanomedicine development. © 2025 selection and editorial matter, Rishi Paliwal and Shivani Rai Paliwal. All rights reserved.