Table 3.
Results of the haemolysis test performed on various excipients (ND: not determined; results above 5% of haemolysis have been greyed out).
| Percentage of Haemolysis (%) | |||||
|---|---|---|---|---|---|
| Excipient Concentration (mg/mL) | 0.05 | 0.1 | 0.25 | 2.5 | |
| Labrafac® WL 1349 | Medium chain triglyceride | <1 | <1 | <1 | 1.1 ± 0.8 |
| Miglyol® 812 | Medium chain triglyceride | 1.2 ± 0.5 | <1 | 1.0 ± 0.9 | 3.2 ± 0.9 |
| Maisine® CC | Glycerol monolinoleate | ND | |||
| Peceol® | Glycerol mono-oleates (type 40) | ND | |||
| Plurol® Oleique CC 497 | Polyglyceryl-3 dioleate | ND | |||
| Lipoid® E PC | Egg yolk phosphatidylcholine | 3.2 ± 0.22 | 3.5 ± 0.9 | 3.8 ± 0.6 | 5.0 ± 0.8 |
| Lipoid® S 100 | Soy phosphatidylcholine | 3.0 ± 0.4 | 3.5 ± 1.6 | 3.1 ± 0.5 | 3.7 ± 1.0 |
| Lipoid® S LPC 80 | Soy lysophosphatidylcholine | 69.6 ± 7.3 | ND | 54.5 ± 7.8 | 67.7 ± 94.4 |
| Kollisolv® PEG 400 | Macrogol | 2.0 ± 0.6 | 2.0 ± 0.5 | 3.1 ± 1.4 | 2.5 ± 1.3 |
| Kolliphor® HS15 | Macrogol 15 hydroxystearate | <1 | <1 | 1.0 ± 0.8 | 22.9 ± 15.1 |
| Kolliphor® EL | Macrogolglycerol ricinoleate | <1 | 1.3 ± 3.1 | <1 | 4.6 ± 0.2 |
| Kollisolv® PG | Propylene glycol | 2.4 ± 0.9 | 3.4 ± 1.2 | <1 | <1 |
| Captex® 200 | Propylene glycol dicaprylocaprate | 1.6 ± 0.8 | 1.5 ± 0.1 | 2.6 ± 1.9 | 19.9 ± 10.4 |
| Labrafil® M1944 | Oleoyl macrogol-6 glycerides | <1 | ND | 3.6 ± 0.9 | 100.0 ± 15.8 |
| Labrafil® M2125 | Linoleoyl macrogol-6 glycerides | 1.6 ± 0.3 | 3.8 ± 0.6 | 61.2 ± 4.1 | ≥100 |
| Labrasol® | Caprylocaproyl macrogol-8 glycerides | <1 | <1 | 27.1 ± 8.5 | ≥100 |
| Transcutol® HP | Diethylene glycol monoethyl ether | <1 | <1 | <1 | <1 |
| Tween® 80 | Polysorbate 80 | 1.2 ± 0.2 | 2.1 ± 0.5 | 20.9 ± 4.8 | 86.7 ± 2.7 |