Table 2.
Evaluation of emulsification and phase separation according to the combination of preselected excipients
| 2:4:4 (w/w %) | Dilution media | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Oil | Surfactant | Cosurfactant | Water | pH 1.2 | pH 4.0 | pH 6.8 | ||||
| Gradea | Phase separationb | Grade | Phase separation | Grade | Phase separation | Grade | Phase separation | |||
| Capmul MCM | Labrasol | Transcutol P | D | O | C | O | C | O | C | O |
| Tetraglycol | C | O | C | O | C | O | C | O | ||
| Pluronic L64 | Transcutol P | C | O | C | O | D | O | C | O | |
| Tetraglycol | C | X | C | O | C | O | C | O | ||
| Tween 80 | Transcutol P | A | X | B | O | B | Δ | B | O | |
| Tetraglycol | B | X | B | O | B | Δ | B | O | ||
| Tween 20 | Transcutol P | A | X | A | Δ | A | Δ | B | X | |
| Tetraglycol | B | X | B | Δ | A | Δ | B | X | ||
| Cremophor EL | Transcutol P | A | X | A | X | A | X | A | X | |
| Tetraglycol | A | X | A | X | A | X | A | X | ||
Notes:
a
The grade was classified according to Table S1 (supplementary materials): grade A (excellent), grade B (good), grade C (fair), or grade D (poor).
b
Phase separation: O (phase separation occurred; emulsion did not form when remixed), Δ (phase separation occurred; when remixed, emulsion was formed), X (no phase separation occurred).