Product quality evaluation of marketed veterinary Ivermectin formulations in Addis Abeba

Document Type : Original Article


1 Department of Pharmaceutical Technology, Institute of Health Sciences, Near East University, Turkiye & Ethiopian Agricultural Authority, Addis Ababa, Ethiopia

2 Department of Animal Science, Werabe University, Werabe, Ethiopia

3 University of Gondar, College of Veterinary Medicine and Animal Sciences, Gondar, Ethiopia

4 Department of Pharmaceutical Technology, Institute of Health Sciences, Near East University, Turkiye

5 Ethiopian Agricultural Authority, Addis Ababa, Ethiopia

6 Department of Pharmaceutical Technology, Altinbas University, Istanbul, Turkiye


Objectives: To assess the prevalence of substandard products, a quality study based on the United States Pharmacopeia (USP) standards was conducted on the veterinary medicinal product ivermectin.
Methods: From September 2020 to January 2021, a cross-sectional quality analysis was carried out on 19 samples of pharmaceutical products. These samples were obtained from all veterinary retail outlets in Addis Ababa, Ethiopia. The analysis included organoleptic assessment for packaging-related information and physical appearance, as well as high-performance liquid chromatography (HPLC)-based physicochemical analysis for identity, assay, packaging uniformity, and HLB ratio. The procedures followed were in accordance with the USP recommendations. The quality analysis took place at the national veterinary drug quality test center.
Results: The quality analysis has revealed the presence of substandard products for uniformity of packaging (15.8%), API assay (15.8%), and filling to a volume (16.67%). However, both sampled products demonstrated the expected API, recommended physical appearance, and consistent packaging information. The prevalence ratio values for all H1B1a/(H1B1a+H1B1b) chemical species were greater than 0.95.
Conclusion: The findings from this study clearly indicate the alarming presence of substandard veterinary pharmaceutical products. This highlights the need for strengthening the regulatory surveillance system.


Main Subjects

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