Table 5.
Physical stability of placebo NLC formulations (n=2) prepared with different lipids (solid and/or liquid) post autoclave sterilization.
| Formulation | Solid lipid (mg) | Liquid lipid (mg) | Poloxamer 188 (mg) | Tween®80 (mg) | Glycerin (mg) | Result |
|---|---|---|---|---|---|---|
| F-1 | GMS (400) | _ | 5 | _ | _ | No change |
| F-2 | GMS, DSPE (1:1) 9 parts (270, 270) | Oleic acid 1 part (60) total 9:1 (S:L) | 25 | 75 | 225 | Failed |
| F-3 | Precirol (360) 9 parts | Oleic acid 1 part (40) total 9:1 (S:L) | _ | 250 | _ | Discoloration in one formulation |
| F-4 | GMS (300) 3 parts | Castor oil (100) 1 part ; 3:1 (S:L) | 5 | _ | _ | No change |
| F-5 | Compritol (200) | Castor oil (200) | 25 | 75 | 225 | No change |
| F-6 | GMS (200) | Castor oil (200) | 25 | 75 | 225 | No change |
| F-7 | GMS (200) | Oleic acid (200) | 25 | 75 | 225 | No change |
| F-8 | GMS (300) | Soyabean oil (300) | 25 | 75 | 225 | No change |
| F-9 | GMS, DSPE (150,150) (1:1) | Soyabean oil (300) | 25 | 75 | 225 | No change |
| F-10 | GMS (300) | Sesame oil (300) | 25 | 75 | 225 | No change |
| F-11 | GMS, DSPE (150,150) (1:1) | Sesame oil (300) | 25 | 75 | 225 | No change |
| F-12 | GMS, DSPE (150,150) (1:1) | Castor oil (300) | 25 | 75 | 225 | No change |
| F-13 | GMS (300) | Miglyol 829 (300) | 25 | 75 | 225 | No change |
| F-14 | GMS, DSPE (150,150) (1:1) | Miglyol 829 (300) | 25 | 75 | 225 | Discoloration |
| F-15 | GMS (300) | Capryol 90 (300) | 25 | 75 | 225 | No change |
| F-16 | GMS, DSPE (150,150) (1:1) | Capryol 90 (300) | 25 | 75 | 225 | No change |
| F-17 | GMS (300) | Lauroglycol (300) | 25 | 75 | 225 | No change |
| F-18 | GMS, DSPE (150,150) (1:1) | Lauroglycol (300) | 25 | 75 | 225 | No change |
| F-19 | GMS (300) | Lauroglycol (300) | 25 | 75 | 225 | No change |
| F-20 | GMS, DSPE (150,150) (1:1) | Lauroglycol (300) | 25 | 75 | 225 | No change |
| F-21 | GMS (300) | Labrafac (300) | 25 | 75 | 225 | No change |
| F-22 | GMS, DSPE (150,150) (1:1) | Labrafac (300) | 25 | 75 | 225 | No change |
| F-23 | GMS (300) | Isopropyl Myristate (300) | 25 | 75 | 225 | No change |
| F-24 | GMS, DSPE (150,150) (1:1) | Isopropyl Myristate (300) | 25 | 75 | 225 | No change |
| F-25 | GMS (300) | Labrafil (300) | 25 | 75 | 225 | No change |
| F-26 | GMS, DSPE (150,150) (1:1) | Labrafil (300) | 25 | 75 | 225 | No change |
| F-27 | GMS (300) | Transcutol (300) | 25 | 75 | 225 | No change |
| F-28 | GMS, DSPE (150,150) (1:1) | Transcutol (300) | 25 | 75 | 225 | Failed |