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

Abstract

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.

Stabilization of the pharmaceutical finished dosages form by using various techniques

“…The cake was completely dissolved in few min. Same type of results were obtained in previously published literature 13 . Based on the physical test results it was depicted that the lyophilized product was within the acceptance criteria.…”

A Review of the Potential of Poly-(lactide-co-glycolide) Nanoparticles as a Delivery System for an Active Antimycobacterial Compound, 7-Methyljuglone

“…An appropriate zeta potential, on the other hand, can enhance the stability of the nanoparticles. This enhancement can assist in ensuring the long-term stability and shelf-life of PLGA nanoparticles, which is also essential for their practical use [ 97 ]. Research on stabilizing formulations, preventing aggregation, and preserving drug integrity over extended periods is necessary.…”

Targeted Liposomal Drug Delivery: Overview of the Current Applications and Challenges

“…Notably, lyophilization has been effective in increasing the shelf-life of nanoparticulate drug products [ 155 ]. The lyophilization process creates a solid powder from a liquid solution, and the powdered liposomes better retain their size characteristics and encapsulated drug throughout storage [ 156 ]. Ambisome ® and Visudyne ® are two examples of lyophilized liposomal drug products that have already been FDA-approved [ 156 ].…”

“…The lyophilization process creates a solid powder from a liquid solution, and the powdered liposomes better retain their size characteristics and encapsulated drug throughout storage [ 156 ]. Ambisome ® and Visudyne ® are two examples of lyophilized liposomal drug products that have already been FDA-approved [ 156 ]. Despite the regulatory success, however, there are still many questions surrounding lyophilization.…”