Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats.
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2010
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The purpose of this study was to determine naproxen concentrations in rat plasma samples by HPLC and to compare
the bioavailability of a generic and two compounded naproxen sodium suspensions (test 1 and test 2). Analysis was run
at a fl ow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile: NaH2PO4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using
a C18 column (150 mm x 4.6 mm, 5 μm). The calibration curve was linear (R2 = 0.9987) over the range of 0.25 - 200
μg.mL-1. The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. Cmax, Tmax and AUCt were 191.25
± 11.17 μg.mL-1, 1.00 ± 0.106 h and 2438.16 ± 291.34 μg.h.mL-1 for the reference drug, 188.22 ± 24.78 μg.mL-1, 1.06 ±
0.092 h and 1755.02 ± 228.90 μg.h.mL-1 for test 1, and 160.50 ± 10.58 μg.mL-1, 0.66 ± 0.102 h and 1955.28 ± 142.80
μg.h.mL-1 for test 2. No signifi cant differences were found based on analysis of variance, with mean values and 90% CI
of test2/reference ratio (Cmax 83.92% and AUCt 80.19%). For test1/reference ratio, the result was Cmax 98.41% and AUCt
71.98%. Based on these results, it can be concluded that the validated method was successfully applied to this study;
the test 1 formulation failed to demonstrate a bioequivalence to the reference drug; however, the test 2 and reference
naproxen sodium suspension were bioequivalent in terms of the rate and extent of absorption under these conditions.
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Validation, Pharmacokinetics
Citação
SOLON, L. G. da S. et al. Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats. Journal of Bioanalysis & Biomedicine, v. 2, p. 48-54, 2010. Disponível em: <https://www.omicsonline.org/comparative-bioavailability-of-a-generic-and-two-compounded-naproxen-sodium-suspensions-administered-to-rats-1948-593X.1000021.php?aid=336>. Acesso em: 10 jan. 2017.