BIOAVAILABILITY OF VALSARTAN LIQUID ORAL DOSAGE FORMS

The oral bioavailability of valsartan from extemporaneous suspension and solution formulation was evaluated relative to tablet formulation in two separate open label, randomize crossover studies in healthy adults. In both studies, plasma concentrations of valsartan after oral administered were analyzed using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods and the corresponding pharmacokinetic parameters were estimated using noncompartmental analysis. The peak plasma concentration (Cmax) and area under the concentration time-curves (AUC(0-∞)) of valsartan from the extemporaneous suspension were higher by 1.93- and 1.56-fold, respectively, relative to the tablet formulation (p<0.001). The Cmax and AUC(0-∞) of valsartan from the oral solution were higher by 2.21- and 1.75-fold, respectively, relative to the tablet formulation (p<0.001). These results indicate that both rate and extent of absorption of valsartan are higher from the two liquid dosage forms (extemporaneous suspension and solution formulations) relative to the solid oral dosage form (tablet formulation).