Abstract

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Over the counter (OTC-drugs) oral preparations being classified as non-sterile pharmaceutical products are easily prone to microbial contamination. The presence of microbial contaminants in these products may cause spoilage resulting in physical and chemical changes, as well as risk of infection or potential health hazard to the patients. A study aimed at evaluating the microbiological quality of some OTC drugs commonly dispensed to patients in Katsina was conducted from April, 2017 to March, 2019. One hundred and twenty-five (125) samples of four different OTC drugs on sale were evaluated for microbial quality using standard procedures as described in the official monograph of the British and United Stated pharmacopoeia. Incidence of microbial contamination was observed in 60 (48%) of the tested samples with 23 (18.4%) of the tested preparations having microbial count exceeding the USP and BP acceptable limit for the microbiological quality of non-sterile oral dosage forms. Bacillus species were the predominant contaminants recovered from the tested products. The study revealed a considerable level of microbial contamination in the examined products and thus highlighted the need for the manufacturers of these products to pay more attention and adhere strictly to the guidelines of the current good manufacturing practices

Keywords: Microbial contamination, Non-sterile, OTC, British and United States pharmacopoeia.