TABLE 1.
PLGA-MPs acceptance criteria.
| Test | Acceptance criteria |
|---|---|
| Appearance | Clear, colorless solution, practically free from particulate matter |
| PSD (Particle size distribution) | 3 µm ≤ PSD (0.5) ≤ 9 µm |
| Morphology by SEM | Smooth-surface spherical particles |
| rhNGF efficiency of encapsulation (%) by ELISA | ˃50% |
| rhNGF release (mg/ml) | Controlled release (≥50 days) |
| Potency (TF-1 proliferation bioassay) | 70%–130% of reference material |