Table 1.
Vesicle Size Distribution and Drug Encapsulation of 50 mg/mL CFIa
| Mean vesicle size (nm) [SD]b | Encapsulation (%)b | |||
|---|---|---|---|---|
| Time (months) | Time (months) | |||
| Formulation | 0.03 | 3 | 0.03 | 3 |
| Refrigerated | ||||
| Control CFI | 89.2 [27.0] | 90.2 [23.6] | 99.5 | 99.2 |
| Frozen | ||||
| pH 5.9 | 98.5 [31.8] | 99.6 [34.7] | 82.2 | 80.9 |
| pH 5.3 | 103.8 [37.1] | 100.3 [31.4] | 79.3 | 83.2 |
| pH 4.9 | 103.4 [40.2] | 96.7 [31.6] | 77.2 | 83.6 |
| pH 4.6 | 103.9 [38.1] | 99.6 [30.7] | 78.9 | 82.1 |
a
Control and pH adjusted 12.5 mg/mL CFI formulations containing 90 mg/mL sucrose, 0.1% polysorbate 20 after storage for 1 day (0.03 months) or 3 months.
b
Vesicle size data are reported as the mean (in nm) and standard deviation (SD). The encapsulation data are reported as the mean of duplicate analysis. The individual encapsulation values did not differ by more than 0.2% from the mean value.