Table 2.
Post-mortem evaluation of organs and tissues in Sprague Dawley rats
| Anatomical location Abnormality | Saline | LN-PLP (in mg/kg) | Free PLP (in mg/kg) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.5 | 2 | 8 | 15 | 60 | |||||||||
| M | F | M | F | M | F | M | F | M | F | M | F | ||
| Adrenal Cortex | Minimal atrophy | - | - | - | - | 1 | - | 4 | 1 | - | - | 1 | - |
| Bone marrow | Fatty change | 5 | 7 | 8 | 8 | 8 | 10 | 10 | 10 | 9 | 9 | 9 | 9 |
| Heart | Minimal myocardial degeneration | - | - | - | - | - | - | - | - | - | - | 2 | - |
| Injection site | Hemorrhage and mild inflammation 3 | 2 | - | - | - | - | - | 2 | 2 | - | 6 | 3 | |
| Kidney | Minimal infarct | - | - | - | - | - | 1 | - | - | - | 1 | ||
| Minimal nephropathy | - | - | - | - | - | - | - | 4 | - | 1 | - | 1 | |
| Liver | Hepatocellar vacuolation | - | - | - | 1 | - | 3 | 4 | 2 | 4 | 7 | 5 | 9 |
| Mild infarct or necrosis | - | - | 1 | - | - | - | - | - | 2 | - | 1 | - | |
| Lungs | Minimal hemorrhage | 4 | 2 | - | - | - | - | 1 | - | - | - | 5 | 2 |
| Mild inflammation | 1 | 3 | - | - | - | - | - | - | - | - | 1 | - | |
| Mesenteric | Minimal lymphoid depletion | - | - | - | - | - | - | 8 | 6 | - | - | 3 | 7 |
| Spleen | Minimal lymphoid depletion | - | - | - | - | - | - | 10 | 5 | - | - | 1 | 2 |
| Thymus | Mild lymphoid depletion | - | - | - | - | - | - | 9 | 9 | - | 2 | 9 | 10 |
| Mild hemorrhage | - | - | 2 | - | 1 | 1 | - | - | - | - | - | - | |
| Thyroid | Mild hyperplasia | 1 | 4 | - | - | - | - | 3 | 2 | - | - | 2 | 1 |
| Brown fat | Macrovacuolar change | - | - | 5 | - | 8 | - | 9 | 6 | 9 | 4 | 9 | 8 |
| Prostate | Minimal atrophy | - | na | - | na | - | na | - | na | - | na | 2 | na |
| Seminal vesicle | Minimal atrophy | - | na | - | na | - | na | - | na | - | na | 2 | na |
| Uterus | Minimal dilatation | na | 4 | na | - | na | - | na | 1 | na | - | na | - |
F, female rats; LN, liposomal nanoparticle; M, male rats; na, not assessed (due to gender); PL, prednisolone (active metabolite); PLP, prednisolone phosphate (prodrug); T½; terminal half-live.