From Conventional to Next-Generation Strategies: Recent Advances in Polymeric Micelle Preparation for Drug Delivery.

Polymeric micelles are promising nanocarriers for hydrophobic drug delivery, offering enhanced solubility, circulation time, and targeted release. This review presents a comprehensive evaluation of micelle preparation strategies, spanning conventional methods such as direct dissolution, dialysis, and thin-film hydration to emerging techniques including microfluidics, supercritical fluids, stimuli-responsive systems, and PEG-assisted assembly. Each method is compared in terms of scalability, reproducibility, solvent use, and regulatory compatibility. Among them, PEG-assisted methods show particular promise due to their simplicity and industrial readiness. We also explore the impact of fabrication strategy on drug loading, stability, and therapeutic efficacy across applications in cancer, infection, and inflammation. Finally, the review discusses key challenges in storage, manufacturing, and regulation, and highlights potential solutions through Quality-by-Design and scalable process integration. These insights provide guidance for the rational development of clinically translatable micelle-based drug delivery systems.