Ministry of Health, Labour and Welfare ‘Guidelines for the Development of Liposome Preparations (March 28, 2016)’ and Physical Property Evaluation

by Ai Kano, Sunday, 5th July 2020

The guidelines state in ‘3.2.2 Analysis of Preparation Characteristics’ that various physical property evaluations are required as follows.
① “Particle Size Distribution: Display with quantitative indicators along with mean or median values. Testing methods include dynamic light scattering measurement and laser diffraction measurement. It is important to clearly state the distribution display used for analysis (number-based distribution, volume-based distribution, etc.).”
② “Surface Charge (Zeta Potential): Since surface charge cannot be directly measured, it is generally evaluated and considered as zeta potential. The dominant testing method is electrophoretic light scattering (laser Doppler method).”
③ “Thermodynamic Characteristics of Liposome Membrane: Evaluated by differential scanning calorimetry and fluorescence spectral characteristics of lipid membrane-inserting fluorescent probes depending on temperature. Thermodynamic characteristics like exothermic or endothermic profiles are useful indicators for the fluidity and homogeneity of lipid bilayers.”
This page introduces the relationship between necessary parameters for evaluation and corresponding analytical equipment.
① Particle size distribution (particle size measurement)
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