title: Bioavailability of valsartan oral dosage forms.
abstract: 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).
authors.affiliation: Novartis Institutes for Biomedical Research, East Hanover, NJ, USA.
authors.forename: Gangadhar
authors.initials: G
authors.lastname: Sunkara
authors.affiliation: Novartis Institutes for Biomedical Research, Hyderabad, India.
authors.forename: Girish
authors.initials: G
authors.lastname: Bende
authors.affiliation: Novartis Institutes for Biomedical Research, Cambridge, MA, USA.
authors.forename: Anisha E
authors.initials: AE
authors.lastname: Mendonza
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Solar-Yohay
authors.affiliation: Novartis Institutes for Biomedical Research, Hyderabad, India.
authors.forename: Shibadas
authors.initials: S
authors.lastname: Biswal
authors.affiliation: Novartis Healthcare Pvt. Ltd., Hyderabad, India.
authors.forename: Srikanth
authors.initials: S
authors.lastname: Neelakantham
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Wagner
authors.affiliation: Novartis Institutes for Biomedical Research, East Hanover, NJ, USA.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Flarakos
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Yiming
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Novartis Institutes for Biomedical Research, East Hanover, NJ, USA.
authors.forename: Venkateswar
authors.initials: V
authors.lastname: Jarugula
keywords: pediatric formulations; pharmacokinetics; valsartan