[Bioequivalence in vitro evaluation of some antibacterial generic dosage forms]

Abstract

In this work, bioequivalence between generic and corresponding original brand-name dosage forms of some antibacterial drugs, frequently prescribed in developing countries, have been examined using in vitro dissolution testing. For this purpose, tablet or hard capsule formulations of five active substances (amoxycillin, ampicillin, co-trimoxazole (sulphamethoxazole/trimethoprim), metronidazole and penicillin V) have been retained. For each active substance, batch samples of three generic and one test formulations have been submitted to the pharmaceutical quality control and dissolution testing. Results obtained have shown that all samples examined met the specifications of quality edited by the pharmacopeias. On the other hand, interchangeability between generic and corresponding test formulations should be possible since their dissolution profiles are superposables enough.