Quality of the antibiotics--amoxicillin and co-trimoxazole from Ghana, Nigeria, and the United Kingdom.

Ifeyinwa Fadeyi,Harparkash Kaur,Naiela Mailk,Mirza Lalani,Albert Van Wyk

doi:10.4269/ajtmh.14-0539

Abstract

Little is known about the quality of antibiotics despite being in high demand globally. Thirty five samples (27 brands) of the antibiotics amoxicillin (N = 20; 16 brands) and co-trimoxazole (N = 15; 11 brands), manufactured in six countries (China, Ghana, India, Ireland, Nigeria, and United Kingdom), were purchased in Ghana, Nigeria, and the United Kingdom. Their quality was assessed using German Pharma Health Fund (GPHF) MiniLab® as the screening tool—two capsules of amoxicillin (10%) and two tablets of co-trimoxazole (20%) failed the thin-layer chromatography (TLC) test. Definitive drug quality was measured using high-performance liquid chromatography–photodiode array detection (HPLC-PDA) for content of the stated active pharmaceutical ingredients (APIs) and bioavailability was determined with in vitro dissolution testing. All the samples of amoxicillin complied with U.S. Pharmacopeia (USP) tolerance limits, but 60% tablets of co-trimoxazole (purchased in Ghana and Nigeria) did not. There was disparity in the results obtained for co-trimoxazole and amoxicillin samples using the MiniLab® TLC tests. This highlights the need to invest in techniques such as HPLC-PDA and dissolution testing alongside the screening tests for assessing drug quality.

Highlights

IntroductionAntibiotics such as co-trimoxazole (sulfamethoxazole/ trimethoprim—a dihydrofolate reductase inhibitor and a sulphonamide) and amoxicillin (a b-lactam) are used globally in the public health sector for treatment of bacterial infections
Antibiotics such as co-trimoxazole and amoxicillin are used globally in the public health sector for treatment of bacterial infections
Co-trimoxazole is commonly used as prophylaxis against secondary bacterial infections among human immunodeficiency virus (HIV)-1-infected tuberculosis patients for whom it has shown a marked reduction in morbidity and mortality rates.[4]

Summary

Introduction

Antibiotics such as co-trimoxazole (sulfamethoxazole/ trimethoprim—a dihydrofolate reductase inhibitor and a sulphonamide) and amoxicillin (a b-lactam) are used globally in the public health sector for treatment of bacterial infections. Antibiotics in general are crucial for use as chemotherapeutic agents in treating bacterial infections and microbe-borne diseases making them vital for the prevention of mortality in pneumonia, diarrheal diseases, human immunodeficiency virus (HIV), tuberculosis, and malaria.[1,2,3] Co-trimoxazole is commonly used as prophylaxis against secondary bacterial infections among HIV-1-infected tuberculosis patients for whom it has shown a marked reduction in morbidity and mortality rates.[4] Amoxicillin is a broad-spectrum antibiotic used for the treatment of several bacterial infections.[5]. There is widespread concern about the quality of antimalarial drugs, with up to 35% poor quality antimalarials reported to be in malaria-endemic countries.[6,7] little is known about the quality of antibiotics, despite being in high demand globally. Data are limited from the developing world where first-line antibiotics can be obtained without prescription from pharmacies, grocery shops, and even mobile drug peddlers.[10,11]

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Results

Conclusion