TABLE 2.
PK Parameter Estimates of PolybHbs (10:1, 20:1, 30:1, and 40:1) Following a 50% Exchange Transfusion
| Estimate | Total Hb | Hb(Fe2+) | Hb(Fe3+) |
| PolybHb (10:1) | |||
| Dose (mg) | 1282 ± 96 | 1252 ± 89 | 31 ± 11 |
| Cmax (mg/ml) | 22.0 ± 1.8 | 17.8 ± 1.4 | 6.9 ± 2.6 at Tmax = 1.0 h |
| AUC0–∞ (mg h/ml) | 206 ± 5.9 | 159 ± 9.6 | 46 ± 4.9 ( 22 ± 2.8% total AUC0–∞) |
| Cltotal (ml/h) | 6.3 ± 0.6 | 8.0 ± 1.0 | |
| Vd (ml) | 108 ± 14 | 128 ± 15 | |
| t1/2 β (h) | 10.9 ± 0.3 | 10.6 ± 0.6 | |
| PolybHb (20:1) | |||
| Dose (mg) | 1375 ± 17 | 1341 ± 21 | 47 ± 5.0 |
| Cmax (mg/ml) | 28.9 ± 1.7 | 18.9 ± 1.3 | 11.4 ± 5.0 at Tmax = 5.5 h |
| AUC0–∞ (mg h/ml) | 682 ± 86 | 271 ± 40 | 358 ± 20 (46 ± 1.3% total AUC0–∞) |
| Cltotal (ml/h) | 2.0 ± 0.10 | 3.7 ± 0.01 | |
| Vd (ml) | 54 ± 3.2 | 89 ± 1.7 | |
| t1/2 β (h) | 19 ± 2.0 | 13.5 ± 0.30 | |
| PolybHb (30:1) | |||
| Dose (mg) | 1076 ± 80 | 1036 ± 82 | 40 ± 5.0 |
| Cmax (mg/ml) | 31.9 ± 4.0 | 29.1 ± 4.1** | 6.7 ± 0.96 at Tmax = 4.5 h |
| AUC0–∞ (mg h/ml) | 1126 ± 74**,* | 750 ± 62**,* | 375 ± 56 (33 ± 3.9% total AUC0–∞) |
| Cltotal (ml/h) | 0.90 ± 0.2**,* | 1.4 ± 0.2**,* | |
| Vd (ml) | 39 ± 6.8**,* | 50 ± 11**,* | |
| t1/2 β (h) | 31.1 ± 1.7**,* | 23.5 ± 1.8**,* | |
| PolybHb (40:1) | |||
| Dose (mg) | 1259 ± 20 | 1244 ± 37 | 43 ± 2.8 |
| Cmax (mg/ml) | 22.2 ± 0.10*** | 19 ± 0.41*** | 6.8 ± 0.87 at Tmax = 7.3 h |
| AUC0–∞ (mg h/ml) | 526.5 ± 42*** | 276.9 ± 22*** | 249 ± 26 (47 ± 2.1% total AUC0–∞) |
| Cltotal (ml/h) | 2.5 ± 0.17**,*** | 4.5 ± 0.28**,*** | |
| Vd (ml) | 59 ± 7.9**,*** | 98 ± 11**,*** | |
| t1/2 β (h) | 15.3 ± 1.2**,*** | 13.1 ± 0.77**,*** |
* = Significant difference between 20:1 PolybHb parameter estimates (p < 0.05).
** = Significant difference between 10:1 PolybHb parameter estimates (p < 0.05).
*** = Significant difference between 30:1 PolybHb parameter estimates (p < 0.05).