Table 6.
Pharmacokinetic parameters of valsartan after oral administration of the pure powder, marketed formulation (Valzaar), and liquid and solid SMEF.
Parameters | Pure drug | Valzaar | L-SMEF | S-SMSD | S-SMFD |
---|---|---|---|---|---|
C max (μg/mL) | 0.83 ± 0.14 | 1.20 ± 0.23 | 3.40 ± 0.89 | 3.20 ± 1.23 | 3.14 ± 1.13 |
T max (h) | 1.00 ± 0.21 | 1.10 ± 0.42 | 0.75 ± 0.24 | 1.02 ± 0.53 | 1.05 ± 0.46 |
t 1/2 (h) | 7.83 ± 1.23 | 5.13 ± 1.47 | 5.94 ± 1.25 | 6.06 ± 2.63 | 5.22 ± 2.35 |
Kel (h−1) | 0.088 ± 0.03 | 0.13 ± 0.07 | 0.11 ± 0.04 | 0.11 ± 0.06 | 0.13 ± 0.03 |
AUC t 0–t 12 (μg h/mL) | 3.45 ± 0.95 | 6.33 ± 1.75 | 10.23 ± 2.57 | 10.69 ± 2.14 | 10.28 ± 1.95 |
AUC t 0–t ∞ (μg h/mL) | 6.71 ± 1.34 | 8.41 ± 2.42 | 13.48 ± 4.53 | 13.76 ± 3.73 | 12.92 ± 2.47 |
f 1 | — | — | 2.9 | 3.0 | 2.98 |
f 2 | — | — | 1.6 | 1.68 | 1.62 |
f 1: Relative bioavailability compared to pure drug.
f 2: Relative bioavailability compared to marketed formulation.
Each value is represented in mean ± SD. n = 3.