Nanoliposomes as drug delivery systems: safety concerns

Abstract

The review highlights the safety issues of drug delivery systems based on liposomes. Due to their small sizes (about 80–120 nm, sometimes even smaller), phospholipid nanoparticles interact intensively with living systems during parenteral administration. This interaction significantly affects both their transport role and safety; therefore, special attention is paid to these issues. The review summarises the data on the basic factors affecting the safety of nanoliposomes: composition, size, surface charge, stability, the release of an incorporated drug, penetration into tissues, interaction with the complement system. Attention is paid to the authors' own research of unique phospholipid nanoparticles with a diameter of 20–30 nm. The influence of technological processes of nanoliposome production on their properties is considered. The article also discusses the modern safety assessment criteria contained in the preliminary regulatory documents of the manufacturing countries for new nanoliposome-based drugs being developed or used in the clinic.

Keywords:

• Nanoliposomes
• nanoparticles
• drug delivery system
• safety
• toxicity
• complement system

Disclosure statement

The authors report no conflict of interest.

Additional information

Funding

This work was financed by the Ministry of Science and Higher Education of the Russian Federation within the framework of state support for the creation and development of World-Class Research Centers ‘Digital biodesign and personalized healthcare’ (No. 75-15-2020-913).