Previous presentation: Parts of these studies were presented as a poster and the abstract was published in Clin Pharmacol Therap. 2012;91:S122–S123.
Bioavailability of valsartan oral dosage forms
Article first published online: 10 OCT 2013
© 2013, The American College of Clinical Pharmacology
Clinical Pharmacology in Drug Development
Volume 3, Issue 2, pages 132–138, March/April 2014
How to Cite
Sunkara, G., Bende, G., Mendonza, A. E., Solar-Yohay, S., Biswal, S., Neelakantham, S., Wagner, R., Flarakos, J., Zhang, Y. and Jarugula, V. (2014), Bioavailability of valsartan oral dosage forms. Clinical Pharm in Drug Dev, 3: 132–138. doi: 10.1002/cpdd.56
- Issue published online: 14 MAR 2014
- Article first published online: 10 OCT 2013
- Manuscript Accepted: 15 JUL 2013
- Manuscript Received: 18 JAN 2013
- pediatric formulations;
The oral bioavailability of valsartan from extemporaneous suspension and solution formulations were evaluated relative to tablet formulation in two separate open-label, randomized crossover studies in healthy adults. In both studies, the plasma concentrations of valsartan after oral administration 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 < .001). The Cmax and AUC(0–∞) of valsartan from the oral solution were higher by 2.21- and 1.74-fold, respectively, relative to the tablet formulation (P < .001). These results indicate that both rate and extent of absorption of valsartan are higher in the two liquid dosage forms (extemporaneous suspension and solution formulations) relative to the solid oral dosage form (tablet formulation).