The comparison of the quality of selected brands of antibiotics in Tanzania sourced from different geographical regions

Author:

Mwalwisi Yonah Hebron1,Fimbo Adam Mitangu1,Hoellein Ludwig2,Nandonde Moses13,Sambu Gerald13,Ahmed Babuali13,Juma Abdalla13,Augustine Siya13,Shewiyo Danstan Hipolite13,Kaale Eliangiringa Amos4ORCID,Holzgrabe Ulrike2ORCID

Affiliation:

1. Human and Veterinary Medicines, Tanzania Medicines and Medical Devices Authority (TMDA) , Dar es Salaam , Tanzania

2. Pharmaceutical and Medicinal Chemistry, Institute for Pharmacy and Food Chemistry, Universität Würzburg , 97074 Würzburg , Germany

3. Laboratory Services, Tanzania Medicines and Medical Devices Authority (TMDA) , Dar es Salaam , Tanzania

4. Pharm R&D Lab, School of Pharmacy, Muhimbili University of Health and Allied Sciences , P.O. Box 65545, 11103, Upanga West, Dar es Salaam , Tanzania

Abstract

Abstract Objectives The quality of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets was evaluated to determine whether there is any difference in quality when comparing the country of origin. This was undertaken because it has been claimed that antibiotics manufactured in Europe are of superior quality to those originating from Africa or Asia. Methods Samples of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets were collected from three randomly selected wholesale pharmacies in each city, namely Arusha, Dar es Salaam and Mwanza, Tanzania. The collected samples of collected brands were subjected to quality control testing as per their respective pharmacopoeial monographs. Amoxil 250 mg capsules (Glaxo Wellcome, Mayenne, France), Rocephin (Roche, Switzerland) and Cipro-Denk 500 (Allphamed Pharbil Arzneimittel GmbH, Gottingen, Germany) were used as reference brands for the other generic brands of amoxicillin, ceftriaxone and ciprofloxacin, respectively. Results A total of 31 brands (10 different brands of amoxicillin capsules, 9 of ceftriaxone sodium injections, and 12 of ciprofloxacin tablets) were collected from the targeted regions and subjected to quality control testing. All samples of collected brands complied with the requirements of their respective pharmacopoeial monographs. Conclusions There was no significant difference in quality between brands of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets manufactured in Africa and Asia against those manufactured in Europe in terms of compliance with the respective pharmacopoeial monographs.

Funder

Tanzania Medicines and Medical Devices Authority

Publisher

Oxford University Press (OUP)

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