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Background <p>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.</p> Objectives <p>It is aimed at assessing the quality of three cephalosporin medicines marketed in Addis Ababa city, Ethiopia.</p> Methods <p>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.</p> Results <p>All samples had passed visual inspections and screening test with GPHF-minilab™. Twenty-four samples were subjected for further confirmatory tests. All samples complied for the dissolution and assay tests with USP 44-NF39 specifications. However, two samples, each from cephalexin capsule and ceftriaxone powder for injection failed to meet the uniformity of dosage units’ test. Cephalexin capsule and cefuroxime axetil tablets were found to be more active against <i>S. aureus</i> (with zone of inhibition (Z.O.I.) as 28.7&#xa0;mm and 32.1&#xa0;mm, respectively), while ceftriaxone was found to be most effective against <i>P. mirabilis</i> (Z.O.I. as 33.39&#xa0;mm). For antimicrobial assays, 24 (samples) multiplied by 5 (microorganism types) with total amount of 120 antibiograms were generated. Eighty-five (85) were found to be sensitive, 15 intermediate and 20 resistants.</p> Conclusion <p>The tested medicinal products were of good quality. However, there are differences in the antimicrobial activity effectiveness results against tested bacterial strains. It implies that resistance to Cephalosprins’ is emerging in the study area.</p>

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Quality evaluation of cephalexin, cefuroxime, and ceftriaxone medicines marketed in Addis Ababa city, Ethiopia with three tier level approach and anti-microbial assays

  • 期刊论文

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  • 发表日期：

    2025年10月24日

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  • Worku Birhane,
  • Tigist Getachew,
  • Molalegne Bitew,
  • Mequanint Mitiku,
  • Tibebu Abera,
  • Tadele Eticha,
  • Ayenew Ashenef

摘要

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 subjected for further confirmatory tests. All samples complied for the dissolution and assay tests with USP 44-NF39 specifications. However, two samples, each from cephalexin capsule and ceftriaxone powder for injection failed to meet the uniformity of dosage units’ test. Cephalexin capsule and cefuroxime axetil tablets were found to be more active against S. aureus (with zone of inhibition (Z.O.I.) as 28.7 mm and 32.1 mm, respectively), while ceftriaxone was found to be most effective against P. mirabilis (Z.O.I. as 33.39 mm). For antimicrobial assays, 24 (samples) multiplied by 5 (microorganism types) with total amount of 120 antibiograms were generated. Eighty-five (85) were found to be sensitive, 15 intermediate and 20 resistants.

Conclusion

The tested medicinal products were of good quality. However, there are differences in the antimicrobial activity effectiveness results against tested bacterial strains. It implies that resistance to Cephalosprins’ is emerging in the study area.