Table 6 Stability profile of lyophilized HVD-NLCs (VER-9) in terms of PS, PDI, ZP, and drug content (n = 3) in different storage conditions
Stability parameters | 0 month | 1 month | 3 month | 6 month |
---|---|---|---|---|
Storage condition (5 ± 3 °C) | ||||
PS (nm) | 193.76 ± 2.10 | 191 ± 3.17 | 192.46 ± 4.36 | 198.43 ± 2.90 |
PDI | 0.542 ± 0.075 | 0.556 ± 0.052 | 0.554 ± 0.321 | 0.525 ± 0.251 |
ZP (mV) | − 48.5 ± 1.31 | − 45.3 ± 2.55 | − 42 ± 2.65 | − 46.11 ± 3.11 |
Drug content (%EE) | 100.03 ± 0.03 | 99.53 ± 0.72 | 99.06 ± 1.23 | 98.46 ± 1.67 |
Storage condition (25 ± 2 °C/60 ± 5%RH) | ||||
PS (nm) | 193.76 ± 2.10 | 962.16 ± 12.36 | NM | NM |
PDI | 0.542 ± 0.075 | 1 | NM | NM |
ZP (mV) | − 48.5 ± 1.31 | − 46.25 ± 2.36 | NM | NM |
Drug content (%EE) | 100.03 ± 0.03 | 92.69 ± 0.75 | 87.56 ± 1.26 | 82.14 ± 1.90 |
Storage condition (40 ± 2 °C/75 ± 5% RH) | ||||
PS (nm) | 193.76 ± 2.10 | 865.12 ± 15.26 | NM | NM |
PDI | 0.542 ± 0.075 | 0.963 ± 0.056 | NM | NM |
ZP (mV) | − 48.5 ± 1.31 | − 49.47 ± 2.45 | NM | NM |
Drug content (%EE) | 100.03 ± 0.03 | 91.78 ± 0.44 | 68.24 ± 1.80 | 65.84 ± 7.88 |