Comparaison entre quelques antibiotiques princeps et génériques commercialisés en Algérie via les tests de l’antibiogramme, l’uniformité de masse et la friabilité

Abstract

The inferior quality of generic antibiotics compared to the branded ones may contribute to the problem of AMR according to some studies. The aim of this work is to carry out a comparative study of the antibacterial potency and technological properties of ten antibiotics that belong to three antibiotics families marketed in Algeria. The following families are represented: aminopenicillins (one branded and three generics), macrolides (one branded and two generics) and second generation cephalosporins (one branded and two generics). Our work also includes a survey of health professionals in the Constantine region to assess their perceptions about the use of antibiotics in health care facilities and the extent of antibiotic resistance. Our results indicate that the 190 health professionals surveyed are fully aware of the AMR problem and the irrational use of antibiotics. A significant proportion (62.1%) recognize that there is a difference in quality between branded and generic antibiotics. The disc diffusion technique revealed that the diameters of the inhibition zones of tree generic antibiotics are statistically different (by 19.67%, 29.5% and 51.52 %) than their branded homologs (2 belonging to the amino-penicillin family and 1 to the macrolide family, all tested on the reference strain E. coli). No differences were found for the other generic antibiotics that belong to these families as well as for those belonging to the second-generation cephalosporin family on all reference strains tested (E. coli, P. aeruginosa and S. epidermidis). The quality control tests carried out (mass uniformity and friability) also revealed that all the antibiotics analysed were compliant. Given that the regulatory approval of generic antibiotics is based on their conformity with respect to pharmaco-technical standards (especially similarity of the dissolution profile with that of the branded counterpart), our results indicate that this may not be enough to guarantee the antimicrobial potency equivalence between generic antibiotics and their branded counterparts. This may contribute to the phenomenon of AMR