Bioequivalence study of ibuprofen 400 mg tablets

Abstract

Objective. To determine the bioavailability of two dosage forms of ibuprofen 400mg tablets, for establishing if the multisource (generic) drug is bioequivalent to the reference (Motrin® 400mg tablets). Materials and methods. It was designed an opened study, randomized, two periods, cross over, and seven days washout period, with 12 healthy volunteers (male and female), between 21 and 48 years old, who have taken one tablet of the multisource or reference tablets; according to randomization; with 200 mL of water. After drug intake 4 mL of blood was collected from each volunteer, for quantification of ibuprofen. The plasma samples with ibuprofen and sodium diclofenac (internal standard) were analyzed by liquid chromatography tandem mass spectrometry (LC-MS/MS) with negative ion electrospray ionization using selected reaction monitoring. The bioequivalence was established with pharmacokinetics parameters: area under the curve AUC(0-t), AUC(0-∞) and maximum concentration (Cmax). Results. According to statistical analysis were founded: AUCmultisource(0-t) = 86.85 (ug*h)/mL, AUCRef.(0-t) = 81.20 (ug*h)/mL, AUCmultisource(0-∞) = 88.67 (ug*h)/mL, AUCRef.(0-∞) = 82.83 (ug*h)/mL, Cmáxmultisource = 17.70 ug/mL, CmáxRef.=18.09 ug/mL, with intervals of 0.93-1.24 for AUC(0-t), 0.93-1.24 for AUC(0-∞) and 0.81-1.19 for Cmax. Conclusions. The values founded for AUC(0-t), AUC(0-∞) and Cmax are within the established limits by WHO and FDA (0,80 -1,25), so ibuprofen 400mg tables; multisource drug, is bioequivalent to Motrin 400mg tablets, with regard to both the rate and extent of absorption.