Quality evaluation of cephalexin, cefuroxime, and ceftriaxone medicines marketed in Addis Ababa city, Ethiopia with three tier level approach and anti-microbial assays
Abstract
BACKGROUND: The prevalence of substandard and falsified (SF) medicines hinders progresses towards sustainable development goals in providing quality health care. It is posed as major public health threat. Cephalosporin are beta-lactam antibiotics used for treating penicillin resistant infections and are widely prescribed. Three tiered level approach is a quality assessment methodology that consists of visual and physical inspection of labelling, packaging, and inserts of the dosage form and then performing rapid screening and finally carrying out full pharmacopoeial tests. OBJECTIVES: It is aimed at assessing the quality of three cephalosporin medicines marketed in Addis Ababa city, Ethiopia. METHODS: Different cephalosporin products for post market quality survey were collected from different health care systems in Addis Ababa, Ethiopia. Purposive sampling was employed for sample collection using the WHO and National Regulatory Authority (NRA) guidelines. A total of 56 samples (13 cefuroxime axetil tablets, 21 cephalexin capsules, and 22 samples of ceftriaxone powder for injections) were collected. All samples had been subjected to visual inspection, then screening test with GPHF-minilab™ protocol, and later confirmatory physicochemical tests per U.S. Pharmacopoeia monograph (USP 44-NF39) methods. Finally, antimicrobial effectiveness tests were carried out. RESULTS: All samples had passed visual inspections and screening test with GPHF-minilab™. Twenty-four samples were…
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