生物学的同等性とバイオアベイラビリティのジャーナル

概要

Comparison between Pharmacokinetic and Pharmacodynamic of Single- Doses of Furosemide 40 mg Tablets

Michel Silveira Bragatto, Maurício Bedim dos Santos, Ana Maria Pugens Pinto, Eduardo Gomes, Naura Tonin Angonese, Walniza Fátima Girelli Viezzer, Carmen Maria Donaduzzi and Josélia Larger Manfio

This study was to evaluate and compare the pharmacokinetic and pharmacodynamic behavior of two formulations of furosemide (CAS 54-31-9) 40 mg tablets, administered as a single dose to healthy subjects. Plasma concentrations of furosemide were determined with a validated method by liquid chromatography coupled to mass spectrometry (LC-MS/MS). We obtained the parameters: AUC 0-t , AUC 0-∞ , K el , T 1/2 , C max e T max . The following parameters were determined in urine: Sodium, Potassium and Chlorine and the total volume. The 90% confidence intervals for the ratio of C max (93.63-121.92%), AUC 0–t (96.80-115.72%) and AUC 0-∞ (98.45-117.43%) respectively for test and reference. Statistical analysis of the similarity of the parameters for urinary volume, excretion of sodium, potassium and chlorine and assuming that both formulations reach the same plasma levels, we expect that the pharmacological effect is also the same. Whereas the rate and extent of absorption, both products can be considered therapeutic equivalents.