Table 3

Summary of Z-average diameter and PdI values

Time pointStorage conditionZ-average, nmPdIMain peak, %Main peak, nm
D012.08±0.390.13±0.0499.69±0.2813.00±0.64
D22–8°C11.52±0.260.08±0.0399.40±1.0412.32±0.45
25°C11.28±0.080.06±0.0299.40±1.0411.91±0.28
D42–8°C11.55±0.020.05±0.01100.00±0.0012.18±0.10
25°C11.70±0.310.08±0.04100.00±0.0012.41±0.51
D82–8°C11.41±0.070.05±0.02100.00±0.0011.94±0.19
25°C11.70±0.310.08±0.04100.00±0.0012.41±0.51
2–8°C, unopened vial11.36±0.10*0.05±0.01100.00±0.0011.92±0.15
25°C, unopened vial11.54±0.190.06±0.03100.00±0.0012.11±0.35
  • PdI values were obtained as mean values from triplicate DLS measurements (main peak (%) deriving from size distribution by volume) for all tested samples and storage conditions.

  • *Indicates statistically significant difference compared with the respective Z-average value at D0.

  • D0, day 0 (start); D2, day 2; D4, day 4; D8, day 8; DLS, dynamic light scattering; PdI, polydispersity index.