Evaluation of some selected non sterile pharmaceutical products for bacterial and fungi of clinical importance

Abstract

This study investigated, identified, and quantified microbial contamination of 12 non-sterile pharmaceuticals products frequently made available to Akala Primary Health Care Centre Ibadan, for the possibility of detecting harmful and non-pathogenic microorganisms. Though sterility is not a requirement in official compendia for non-sterile pharmaceuticals, their bioburdens should not exceed the acceptable limit. The representative, syrups, tablets, capsules, and disinfectants from the dispensing unit were selected as guided by the conventional protocol for the study type. Bacteria and fungi of clinical potential were isolated and enumerated using standard microbiology procedures. Ten (10) of the twelve (12) non-sterile pharmaceutical products examined elicited microbial contamination beyond USP acceptable bio-burden standard. The isolates of bacteria identified comprised Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli elicited varied resistance to gentamicin, ciprofloxacin, tetracycline, and erythromycin but susceptible to augmentin, amoxicillin, cloxacillin, and chloramphenicol, while the Candida albicans fungi isolated, were susceptible to ketoconazole and fluconazole at every concentration exposed. The differences in means for CFU/mL and zones of inhibition among the microorganisms isolated were considered, data collected were analyzed using SPSS 15 and the graph was plotted using Graph Pad prism 8.1 Version 5 for Windows. Ten of the twelve (83%) of non-sterile pharmaceuticals products examined were presumably contaminated which could be an indication of improper handling, poor dispensing, poor repackaging, and or non-adherence to Good Manufacturing Practices. Therefore, training and educating the dispensers, as well as patients, on the proper handling and use of medicines to reduce or prevent microbial contamination are hereby advocated.