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Particle Metrology Approach to Understanding How Storage Conditions Affect Long-Term Liposome Stability.

Sean E Lehman1, Kurt D Benkstein1, Thomas E Cleveland2,3

  • 1Bioprocess Measurements Group, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States.

Langmuir : the ACS Journal of Surfaces and Colloids
|August 21, 2023
PubMed
Summary
This summary is machine-generated.

Lipid nanoparticle stability is crucial for drug delivery. This study found lipid composition significantly impacts liposome shelf-life, more than temperature or buffer conditions.

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Area of Science:

  • Biomedical Engineering
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Lipid nanoparticles (LNPs) are versatile nanomaterials for medical drug delivery.
  • Liposomes, a type of LNP, are used therapeutically, carrying genetic materials or pharmaceuticals.
  • Understanding LNP long-term stability is critical for predicting shelf-life and storage conditions.

Purpose of the Study:

  • To investigate factors influencing the long-term stability of liposomes.
  • To determine the impact of lipid composition, buffer conditions (pH/composition), and storage temperature on liposome stability.
  • To inform the development of NIST liposome-based reference materials.

Main Methods:

  • A one-year stability study of liposomes in aqueous solution (no freezing).
  • Evaluation of particle size and number concentration over time.
  • Analysis of stability as a function of varying lipid composition, buffer parameters, and storage temperatures.

Main Results:

  • Lipid composition was identified as the most critical factor affecting liposome stability.
  • Storage temperature and buffer pH/composition had a lesser, though still notable, effect on stability.
  • Particle size and number concentration changes were key indicators of stability.

Conclusions:

  • Lipid composition is paramount for ensuring liposome stability and effective shelf-life.
  • Optimal formulation and storage requirements can be better defined based on these findings.
  • This research contributes to the understanding of long-term storage challenges for soft particles in biopharmaceuticals.