Table 3 Effect of microfluidization processing on unbuffered GLA-AF recovery and physicochemical stability
Processing pressure (psi) | Target GLA concentration (μg/ml) | # Passes | Particle size (Z-ave, nm) | Pdl | Measured GLA concentration | |||
|---|---|---|---|---|---|---|---|---|
DM | T = 6 mo | DM | T = 6 mo | T = DM or 3 mo | T = 6 mo | |||
10, 000 | 100 | 20 | 128 ± 3 | - | 0.25 ± 0.03 | - | - | - |
20 | 156 ± 4 | - | 0.41 ± 0.03 | - | 50 ± 0 | - | ||
20, 000 | 100 | 20 | 58 ± 2 | 56 ± 1 | 0.24 ± 0.01 | 0.23 ± 0.02 | 90 ± 2 | 88 ± 4 |
20 | 118 ± 1 | - | 0.27 ± 0.00 | - | 72 ± 4 | - | ||
30, 000 | 100 | 20 | 81 ± 2 | 92 ± 1 | 0.44 ± 0.02 | 0.47 ± 0.04 | 85 ± 2 | 87 ± 3 |
20 | 100 ± 11 | 92 ± 2 | 0.28 ± 0.06 | 0.40 ± 0.02 | 104 ± 1 | 84 ± 3 | ||
250 | 15 | 133 ± 3 | - | 0.29 ± 0.01 | - | 231 ± 8 | - | |
250 | 15 | 58 ± 1 | - | 0.25 ± 0.02 | - | 232 ± 6 | - | |