Lyophilization of Nanoparticles, Does It Really Work? Overview of the Current Status and Challenges

Nanoparticles are being increasingly used as drug delivery systems to enhance the delivery to and uptake by target cells and to reduce off-target toxicity of free drugs. However, although the advantages of nanoparticles as drug carriers are clear, there are still some limitations, especially in maintaining their long-term stability. Lyophilization, also known as freeze-drying, has been heavily investigated as a solution to this problem. This strategy has been shown to be effective in increasing both the long-term stability of nanoparticles and the shelf life of the drug product. However, the process is still in need of improvement in several aspects, such as the process parameters, formulation factors, and characterization techniques. This review summarizes the advantages and limitations of nanoparticles for the treatment of disease, advantages and limitations, and the status of the lyophilization of nanoparticles for therapeutic use and provides insight into both the advantages and the limitations.