Table 9.
Parameters | Time (Months) | ||||
---|---|---|---|---|---|
0 | 0.5 | 1 | 2 | 3 | |
Refrigerator (4 ± 3 °C) | |||||
Physical stability | |||||
DS (nm) | 155.93 ± 1.39 | 155.13 ± 1.35 | 156.27 ± 1.19 | 157.33 ± 0.59 | 159.2 ± 0.78 |
Đ | 0.64 ± 0.04 | 0.65 ± 0.015 | 0.64 ± 0.015 | 0.66 ± 0.021 | 0.66 ± 0.01 |
ZP (mV) | −19.28 ± 0.45 | −19.23 ± 0.32 | −19.27 ± 0.45 | −18.97 ± 0.75 | −18.49 ± 0.6 |
Chemical stability | |||||
DC (%) | 98.599 ± 0.32 | 98.52 ± 0.38 | 98.41 ± 0.57 | 98.37 ± 0.2 | 98.09 ± 0.5 |
Room condition (25 ± 2 °C/60 ± 5% RH) | |||||
Physical stability | |||||
DS (nm) | 155.93 ± 1.39 | 155.8 ± 1.67 | 155.6 ± 1.25 | 158.3 ± 1.25 | 161.55 ± 1.1 |
Đ | 0.64 ± 0.04 | 0.627 ± 0.025 | 0.65 ± 0.02 | 0.647 ± 0.03 | 0.68 ± 0.006 |
ZP (mV) | −19.28 ± 0.45 | −19.15 ± 0.53 | −18.97 ± 0.31 | −18.77 ± 0.31 | −16.27 ± 0.45 |
Chemical stability | |||||
DC (%) | 98.599 ± 0.32 | 98.42 ± 0.12 | 98.34 ± 0.36 | 98.06 ± 0.33 | 97.92 ± 0.43 |
Humidity chamber (40 ± 2 °C/75 ± 5% RH) | |||||
Physical stability | |||||
DS (nm) | 155.93 ± 1.39 | 156.4 ± 0.6 | 158 ± 1 | 162.37 ± 1.1 | 164.1 ± 1.02 |
Đ | 0.64 ± 0.04 | 0.65 ± 0.01 | 0.653 ± 0.015 | 0.657 ± 0.015 | 0.603 ± 0.006 |
ZP (mV) | −19.28 ± 0.45 | −19.03 ± 0.4 | −18.9 ± 0.3 | −18.63 ± 0.42 | −15.3 ± 0.56 |
Chemical stability | |||||
DC (%) | 98.599 ± 0.32 | 98.44 ± 0.28 | 98.014 ± 0.4 | 97.86 ± 0.37 | 97.48 ± 0.58 |
(DS, Droplet size; Đ, Dispersity; ZP, Zeta potential; DC%, Drug content percentage; RH, Relative humidity).