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Type: Artigo de periódico
Title: Cyclosporine bioequivalence study: quantification using fluorescence polarization immunoassay (FPIA) and radioimmunoassay (RIA)
Author: Mendes, GD
de Oliveira, CH
Sucupira, M
Donato, JL
Moreno, RA
De Nucci, G
Abstract: Objective: The aim of study was to compare the bioavailability of 2 cyclosporine capsule formulations (100 mg; Sigmasporin Microoral from Novaquimica Divisao Nature's Plus Farmaceutica Ltd., Brazil, as test formulation and Sandimmune Neoral from Novartis Biociencias S.A., Brazil, as reference formulation) in 24 healthy male volunteers. Methods: The study was open, randomized, with a 2-period crossover, a 1-week washout interval between doses. Blood samples were obtained over a 12-hour interval after each oral administration of cyclosporine (2 capsules of 100 mg of each formulation). Cyclosporine blood concentrations were quantified using a fluorescence polarization immunoassay (FRIA) method provided Abbott Axsym System and Cyclo-Trac SP. Whole-blood radioimmuoassay (RIA) kit was provided by DiaSorin. These assays provided concentration-time curves for cyclosporine in blood concentration from which the following pharmacokinetic parameters were obtained: AUC(last), AUC(inf), C-max. Results: Geometric mean and 90% Confidence intervals (CI) of Microoral/Neoral as percent ratios were 94.5% (90.8 - 98.4%) for AUC(last), 93.8% (89.7 - 98.1%) for AUC(inf), and 98.1% (94.5 - 101.8%) for C-max when cyclosporine was determined using FPIA and 96.1% (91.9 to 100.6%) for AUC(last), 95.2% (90.2 - 100.5%) for AUC(inf), and 99.4% (96.4 - 102.4%) for C-max using RIA. Conclusion: Since the 90% Cl for Cmax, AUC(last) and AUCinf ratio were within the 80 - 125% interval proposed by US-FDA, it is concluded that Sigmasporin Microoral 100 mg capsule formulation is bioequivalent to Sandimmune Neoral 100 mg capsule formulation with regard to both rate and the extent of absorption.
Subject: cyclosporine
Country: Alemanha
Editor: Dustri-verlag Dr Karl Feistle
Citation: International Journal Of Clinical Pharmacology And Therapeutics. Dustri-verlag Dr Karl Feistle, v. 42, n. 2, n. 125, n. 132, 2004.
Rights: fechado
Date Issue: 2004
Appears in Collections:Unicamp - Artigos e Outros Documentos

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