Bioequivalence evaluation of two brands of furosemide 40mg tablets (Salurin and Lasix) in healthy human volunteers

Abstract

A randomized, two-way, crossover, bioequivalence study was conducted in 24 fasting, healthy, male volunteers to compare two brands of furosemide 40 mg tablets, Salurin (Julphar, UAE) as test and Lasix (Hoechst AG, Germany) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in a joint venture with Al-Mowasah Hospital, Amman, Jordan. One tablet of either formulation was administered with 240 ml of water after a 10 h overnight fast. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested from blood was analysed for furosemide by a validated HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC(0-t), AUC(0-infinity), and C(max) to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the US FDA accepted bioequivalence range of 80%-125%. Based on these statistical inferences, Salurin was found to be bioequivalent to Lasix.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide

“…Many studies reported in the literature asserted that the drug products studied were bioequivalent, but most studies used small subject numbers and statistical methods that do not meet current requirements. Only the Nakib et al81 and Cuadrado et al82 studies appeared to have reached a BE conclusion based on currently accepted methodology. On the other hand, in the Thai,79 Wolf‐Coporda et al,84 McNamara et al,57 and Rubinstein and Rughani85 studies, at least one of the products showed such large differences in pharmacokinetic parameters from those of the comparator that it is most likely that that product would be declared bio in equivalent after application of statistical testing.…”

“…Nakib et al81 reported BE of a brand of furosemide 40 mg tablets versus Lasix®. The compositions of the products were not reported.…”

Analytical issues in HPLC/MS/MS simultaneous assay of furosemide, spironolactone and canrenone in human plasma samples

“…Pharmacokinetic and pharmacodynamic aspects related to administration of furosemide and spironolactone as individual medications are also available in literature [13][14][15][16][17].…”

Use of Green Fluorescent Nano-sensors for the Determination of Furosemide in Biological Samples and Pharmaceutical Preparations

“…After oral dosing of 40 mg FRS, the peak plasma concentration is 1.163 µg/mL 27 , as a result the method could be used in the estimation of the drug in plasma. After preparing the samples, they were analyzed as described before under section (2.5.3).…”