Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Sold in Retail Outlets in Dutsinma Metropolis, Katsina State, Nigeria

Abstract

Background: The presence of microbial contaminants in non-sterile pharmaceutical preparations has been found to not only cause spoilage of numerous products, but they also pose serious health hazards to the consumers. For this reason, non-sterile pharmaceutical products must satisfy the appropriate microbiological purity tests. The objective of this study was to evaluate the incidence and types of predominant microorganisms in non-sterile pharmaceutical preparations commonly sold in retail outlets in Dutsinma, Northwestern Nigeria.

Methods: A total of 121 samples of seven brands of non-sterile pharmaceutical products were subjected to microbial examinations including total aerobic count and presence of microbial pathogens using standard conventional techniques.

Results: Microbial contamination was observed in 28.9% of the tested samples with paracetamol tablets showing a higher incidence of contamination (55%). Bacterial count ranged from 10 to >1000 cfu/ml. The isolated organisms were either of human flora origin or from air-borne sources.

Conclusion: The microbiological quality of the examined products was, in general, adequate. Producers should pay more attention to good manufacturing practices and adhere to guidelines given by relevant government au­thorities. Several measures, including equipment sanitization and automation, moni­toring programs and post-marketing surveillance may be employed to further reduce the level of microbial contamination of non-sterile pharmaceutical products.