Table 2.
Pharmacokinetic parameters (n = 23)
| Ambroxol ER retard capsule 75 mg | Ambroxol IR effervescent tablet 60 mg | Ambroxol IR tablet 30 mg | |
|---|---|---|---|
| AUCSS 0–24, ng × h/ml | 1228 ± 356.6 | 1147 ± 333.4 | 1115 ± 348.4 |
| AUCSS 0–24norm, ng × h/ml | 982.7 ± 285.3 | 1147 ± 333.4 | 1115 ± 348.4 |
| Cmax SS, ng/ml | 76.1 ± 21.1 | 96.4 ± 31.9 | 92.9 ± 30.6 |
| Cmax SS/AUCSS 0–24, 1/h | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.1 ± 0.0 |
| Cmax SS/AUCSS 0–24norm, 1/h | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.1 ± 0.0 |
| Cmin SS, ng/ml | 26.7 ± 10.5 | 24.1 ± 8.3 | 23.2 ± 9.0 |
| Cav SS, ng/ml | 51.2 ± 14.9 | 47.8 ± 13.9 | 46.5 ± 14.5 |
| tmax SS, h | 6.0 (2.0, 12.0) | 1.0 (0.8, 3.0) | 2.0 (0.8, 3.0) |
| PTFSS | 1.0 ± 0.3 | 1.5 ± 0.3 | 1.5 ± 0.3 |
| PTSSS, % | 205.1 ± 82.7 | 317.1 ± 112.3 | 326.5 ± 133.6 |
| tC>75%Cav SS, h | 10.6 ± 1.2 | 8.3 ± 1.0 | 7.9 ± 1.1 |
| tC>75%Cmax SS, h | 8.9 ± 3.3 | 2.4 ± 1.3 | 2.2 ± 1.3 |
Data are arithmetic mean ± SD, except tmax, which is median (min, max)
AUC area under the curve, ER extended release, IR immediate release, PTF peak-trough fluctuation, PTS peak-trough swing, SD standard deviation, SS steady state