MICROBIAL EVALUATION OF SOME NON-STERILE PHARMACEUTICAL PREPARATIONS SOLD

ABSTRACT

Background and Aim: Microbial contamination and subsequent biodegradation of pharmaceuticals is one of the major reasons for product recalls world-wide. . The presence of microbial contaminants in non-sterile pharmaceutical preparations has been found not only to cause spoilage of numerous products but also poses serious health hazards to consumers. Consequently, non sterile preparations are required to pass certain microbiological limit measures.This study was carried out to determine the total aerobic bacterial, yeast and mould count, the type and incidence of microbial contaminants present and the determine the effect of shelve life on the microbial loads of some non-sterile pharmaceutical preparations sold in Benin City, Nigeria. Methods: A total of 198 samples of non sterile preparations were carefully purchased from 18 community pharmacies in Benin City, Nigeria. They were analysed using standard conventional microbiological techniques. Results and conclusions: The findings of this study revealed significant microbial contaminations beyond the acceptable limits. The percentage of the preparations having viable aerobic bacterial count (> 100 CFU/mL) was 18.33% in syrups, 26.31% in suspensions and 13% in tablets. Whereas, for total yeast and mould count, the proportion having fungal count (> 100 CFU/mL) was 23.33% in syrups, 15.79% in suspensions and 8.70% in tablets. Products closer to their expiry dates had more microbial loads. The bacteria isolates were mainly Staphylococcus aureus, Staphylococcus epidermidis and Bacillus subtillis, whereas the fungal isolates comprised Penicillium notatum, Candida albicans, Candida tropicalis and Mucor species. The microbial value of the products tested was not generally acceptable with reference to the United States Pharmacopoeia (USP, 2003). Manufacturers of non-sterile pharmaceutical products must keep to Good Manufacturing Practice (GMP), much efforts such as equipment automation, sterilization of equipment, monitoring programmes and post marketing checks should be put in place to prevent contaminations by microorganisms and compromise of microbial quality of non-sterile preparations.