Comparative Bioavailability of Two Oral Oseltamivir Formulations: Commercial Capsules and an Emergency Solution Prepared During the 2009 Influenza a (H1n1) Outbreak in Mexico
Lina Marcela Barranco-Garduño1,2, Ariadna Cervantes-Nevárez1, Adrian Martínez-Talavera3, Juan Carlos Neri-Salvador1, Gilberto Castañeda-Hernández3, Francisco Javier Flores-Murrieta1,2 and Miriam del Carmen Carrasco-Portugal1*
- *Corresponding Author:
- Miriam del Carmen Carrasco-Portugal, PhD
Unidad de Investigación en Farmacología
Instituto Nacional de Enfermedades Respiratorias
Ismael Cosío Villegas Calz. De Tlalpan 4502
Col. Sección XVI, 14080 México, D.F., Mexico
E-mail: [email protected]
Received Date: August 30, 2011; Accepted Date: November 15, 2011; Published Date: November 17, 2011
Citation: Barranco-Garduño LM, Cervantes-Nevárez A, Martínez-Talavera A, Neri-Salvador JC, Castañeda-Hernández G, et al. (2011) Comparative Bioavailability of Two Oral Oseltamivir Formulations: Commercial Capsules and an Emergency Solution Prepared During the 2009 Influenza a (H1n1) Outbreak in Mexico. J Bioequiv Availab S1: 008. doi: 10.4172/jbb.S1-008
Copyright: © 2011 Barranco-Garduño LM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
This study was designed to evaluate the bioequivalence of two formulations, commercially available capsule of oseltamivir phosphate and an emergency solution prepared to be used under the influenza A (H1N1) outbreak in Mexico. The clinical investigation was designed as a randomized, open-labeled, two-part, two-treatment, two- period crossover study, in 22 healthy male volunteers. Each formulation was administered with 200 ml of water after 10-hour overnight fast. After dosing, serial blood samples were collected for a period of 24 hours. Plasma concentrations were determined by a validated high-performance liquid chromatographic method with fluorescence detection and pharmacokinetic parameters were obtained by non-compartmental approach. Analysis of variance (ANOVA) was carried out using log-transformed AUC last , AUC ∞ and C max and untransformed t max , and 90% confidence intervals for AUC last , AUC ∞ and C max were calculated. If the 90% confidence intervals (CI) for AUC last , AUC ∞ and C max fell fully within the interval 80 – 125%, the bioequivalence of the two formulations was established. The means (test and reference) for AUC last were 3745.386 and 3535.320 ng.h/ml, for AUC ∞ were 3967.991 and 3911.227 ng.h/ml and for C max were 340.335 and 352.737 ng/ml. The geometric mean ratios of the test formulation to reference formulation for AUC last , AUC ∞ and C max (CI) were 101.92% (85.62 – 121.33%), 103.43% (87.29 – 122.56%) and 105.45% (90.86 – 122.39%), respectively. All 90% CI for AUC last , AUC ∞ and C max fell within the Mexican Federal Commission for Prevention of Sanitary Risks (COFEPRIS) accepted bioequivalence range of 80 – 125%. Based on the results, the formulations tested are bioequivalent.