Quality evaluation of Oral Rehydration Salt (ORS) products marketed in Abuja, Nigeria

Abstract

Medicine security remains one of the public health challenges in Sub-Saharan Africa as the report by World Health Organization (WHO) shows that 10.5% of medicines in low and middle-income countries worldwide are falsified or substandard. The study aimed to evaluate the quality of Oral Rehydration Salt (ORS) products sold in pharmacy outlets in Abuja, Nigeria. Seventeen different commercial brands of WHO recommended low-osmolarity ORS finished pharmaceutical products (FPP) were randomly selected from pharmacy outlets in the Federal Capital Territory (FCT) and Gwagwalada Area Council in Abuja. They were assessed for quality based on physicochemical properties and the content of active pharmaceutical ingredients in accordance with the International Pharmacopeia (IP) guidelines. The shelf lives of all the samples were valid, and they all met the visual inspection test, labelling, pH (7.4‒8.0 between23.3‒23.9°C) and moisture content (1‒9 mg/g) requirements. The content assay revealed 88.2%, 88.2%, 64.7%, 47.1%, and 35.3% compliance of the samples for glucose, chloride, citrate, sodium and potassium, respectively. Twelve (76.5%) of the brands failed at least one content assay and 8 (47%) had zero potassium content. The study underscores the need for regular, periodic post-market surveillance on essential medicines sold in the Nigerian market.