Table 3 Stability study of the optimized ALP-loaded NLCs as per the International conference of harmonization (ICH guidelines)
Storage temperature | 25 °C ± 2a | 40 °C ± 2b | ||||||
|---|---|---|---|---|---|---|---|---|
Relative humidity | 60% RH ± 5% RH | 75% RH ± 5% RH | ||||||
Time (months) | 0 | 1 | 3 | 6 | 0 | 1 | 3 | 6 |
Particle size (nm) | 238.1 ± 5.3 | 240.3 ± 5.4 | 243.9 ± 5.8 | 247.7 ± 5.8 | 238.1 ± 5.3 | 241.5 ± 5.5 | 245.6 ± 5.2 | 250.2 ± 5.8 |
Zeta potential (mV) | -31.5 ± 1.2 | -31.0 ± 2.2 | -30.8 ± 1.8 | -30.2 ± 1.8 | -31.5 ± 1.2 | -30.6 ± 2.0 | -30.1 ± 1.5 | -29.3 ± 1.8 |
PDI | 0.115 ± 0.02 | 0.118 ± 0.02 | 0.119 ± 0.03 | 0.121 ± 0.05 | 0.115 ± 0.02 | 0.117 ± 0.01 | 0.124 ± 0.02 | 0.129 ± 0.04 |
Entrapment efficiency (%) | 87.3 ± 1.3 | 85.9 ± 1.4 | 85.19 ± 1.5 | 84.11 ± 1.5 | 87.3 ± 1.3 | 85.16 ± 1.4 | 84.54 ± 1.7 | 83.17 ± 1.5 |