title: Formulation and bioequivalence of two valsartan tablets after a single oral administration.
abstract: The aim of this study is to assess the quality of Valzan(®) tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan(®) tablet (160 mg, valsartan reference formulation). Valzan(®) tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan(®) tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference formulation (Diovan(®)) and the other one with the generic Valzan(®), with a cross-over after the drug washout period of 14 days. Blood samples were collected at fixed time intervals and valsartan concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC(0-48), AUC(0-∞), C(max), T(max), K(e) and T(1/2) were determined for both the tablets and were compared statistically to evaluate the bioequivalence between the two brands of valsartan, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on this statistical evaluation it was concluded that the test tablets (Valzan(®)) is well formulated, since it exhibits pharmacokinetic profile comparable to the reference brand Diovan(®).
authors: College of Pharmacy, An-Najah National University, P.O. Box: 7, Nablus, Palestine. anzaid@najah.edu
authors: Abdel Naser
authors: AN
authors: Zaid
authors: Rita
authors: R
authors: Cortesi
authors: Aiman
authors: A
authors: Qaddomi
authors: Saed
authors: S
authors: Khammash
references: Clin Ther. 1996 Sep-Oct;18(5):797-810
references: 8930424
references: J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Feb 17;832(1):169-72
references: 16426905
references: Arch Pharm Res. 2008 Aug;31(8):1055-9
references: 18787797
references: Clin Pharmacol Ther. 1996 Sep;60(3):341-6
references: 8841157
references: J Clin Invest. 2007 Nov;117(11):3393-402
references: 17965777
references: Pharm Res. 2007 Oct;24(10):1962-73
references: 17458684
references: Xenobiotica. 1997 Jan;27(1):59-71
references: 9041679
references: Eur J Clin Pharmacol. 1997;52(6):441-9
references: 9342579
references: Eur J Clin Pharmacol. 1997;52(2):115-20
references: 9174680
references: J Hum Hypertens. 1997 Aug;11(8):483-9
references: 9322828
references: J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Jan 25;766(2):345-9
references: 11824822
references: Int J Clin Pharmacol Ther. 2002 Jan;40(1):35-40
references: 11837381
references: Eur J Drug Metab Pharmacokinet. 1991 Oct-Dec;16(4):249-55
references: 1823867
references: Clin Pharmacol Ther. 1997 Sep;62(3):272-8
references: 9333102
references: Indian J Pharm Sci. 2008 May-Jun;70(3):372-4
references: 20046750
references: J Hypertens. 1996 Sep;14(9):1147-51
references: 8986917
references: Arzneimittelforschung. 2010;60(2):76-80
references: 20329655