Particle Metrology Approach to Understanding How Storage Condition Affects Long-Term Liposome Stability
Sean Lehman, Kurt D. Benkstein, Thomas Cleveland, Kyle Anderson, Michael J. Carrier, Wyatt N. Vreeland
Lipid nanoparticles are a type of nanomaterial with broad applicability in medicine as drug delivery vehicles. The lipid nanoparticle platform can be loaded with genetic material or pharmaceutical agents for use as drug treatments. These particles are commonly loaded with either mRNA as a therapeutic cargo to generate a desired protein or siRNA to mitigate production of a deleterious protein. Most recently, these particles provide immunity to SARS-CoV-2 and greatly reduce the development of COVID-19. An open question for these types of lipid nanoparticles is what factor(s) affect the long-term stability of the particles. The stability of the particle is of great interest to understand and predict the effective shelf-life and storage requirements. In this report, we detail a one-year study of lipid nanoparticle stability as a function of lipid composition, buffer composition/pH, and storage temperature. This was done in aqueous solution without freezing. The effect of lipid composition is shown to be a critical factor when evaluating stability of the measured particle size and count. Other factors were shown to be less critical but still have some effect. The stability of these particles, which informs formulation and optimal storage requirements, highlights the complex nature of long-term soft particle storage in pharmaceutical applications.
, Benkstein, K.
, Cleveland, T.
, Anderson, K.
, Carrier, M.
and Vreeland, W.
Particle Metrology Approach to Understanding How Storage Condition Affects Long-Term Liposome Stability, Langmuir, [online], https://doi.org/10.1021/acs.langmuir.3c01270, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=934778
(Accessed March 2, 2024)