Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats

• Main Author: Araujo, Aurigena Antunes de
• Publication Date: 2010
• Other Authors: Solon, Lílian Grace da Silva, Guerra, Gerlane Bernardo Coelho, Barichello, José Mário, Pérez-Urizar, José, Soares, Luiz Alberto Lira
• Format: Article
• Language: por
• Source: Repositório Institucional da UFRN
• Download full: https://repositorio.ufrn.br/jspui/handle/123456789/25362; http://dx.doi.org/10.4172/1948-593X.1000021
• topic: Bioavailability studies; Validation; HPLC; Pharmacokinetics; Compounded naproxen sodium suspension

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: NaH 2 PO 4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using a C 18 column (150 mm x 4.6 mm, 5 μ m). The calibration curve was linear (R 2 = 0.9987) over the range of 0.25 - 200 μ g.mL -1 . The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. C max , T max and AUC t were 191.25 ± 11.17 μ g.mL -1 , 1.00 ± 0.106 h and 2438.16 ± 291.34 μ g.h.mL -1 for the reference drug, 188.22 ± 24.78 μ g.mL -1 , 1.06 ± 0.092 h and 1755.02 ± 228.90 μ g.h.mL -1 for test 1, and 160.50 ± 10.58 μ g.mL -1 , 0.66 ± 0.102 h and 1955.28 ± 142.80 μ g.h.mL -1 for test 2. No signi fi cant differences were found based on analysis of variance, with mean values and 90% CI of test2/reference ratio (C max 83.92% and AUC t 80.19%). For test1/reference ratio, the result was C max 98.41% and AUC t 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.