Evaluation of microbial quality of selected blister-packed paracetamol tablets and paracetamol syrups marketed in Nigeria

Abstract

Ten brands of blister-packed paracetamol tablet and twenty brands of paracetamol syrup marketed in Nigeria were evaluated for their microbial quality. While no microbial contaminant was isolated from all blistered-packed paracetamol tablets, ten of syrups were contaminated with organisms such as Escherichia coli, Klebsiellaspp, Pseudomonas aeruginosa and Staphylococcus aureus at 14.3, 21.4, 21.4 and 42.9% occurrence respectively. Penicilliumspp was isolated from two brands. Antibiotic susceptibility profile revealed all bacterial isolates to be multidrug resistant with Escherichia coli resistant to all antibiotics tested, while Staphylococcus aureus isolates were sensitive to Oxacillin, Cefuroxime and vancomycin. Pseudomonas aeruginosa isolates were sensitive to ofloxacin and gentamycin while Klebsiella isolates were sensitive to ofloxacin and nitrofurantoin. The study concluded that compliance with the provisions of good manufacturing practice as well as good quality control play role in determining the microbial bioburden of pharmaceutical products while isolation of multi-drug resistant organisms calls for establishment and adherence to antibiotics use policy in Nigeria.

Keywords: Blister-pack, multidrug resistance, good manufacturing practice, quality control, bioburden