Quality Assessment of Antimicrobial Drugs: Amoxicillin Capsules, Amoxicillin + Clavulanate, Ciprofloxacin and Norfloxacin Tablets from Drug Retail Outlets of Selected Cities in Eastern Ethiopia.

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dc.contributor.advisorAshenef,Ayenew (Assist. Prof.)
dc.contributor.advisorHymete,Ariaya(Prof.)
dc.contributor.authorAnjulo,Hailu
dc.date.accessioned2024-04-23T10:59:54Z
dc.date.available2024-04-23T10:59:54Z
dc.date.issued2023
dc.description.abstractRising incidence of substandard and falsified antimicrobial drugs is an increasing concern in developing nations. The beta-lactams and fluoroquinolones are among the broad-spectrum antimicrobial agents that are most frequently prescribed, inexpensive, and readily available in Ethiopia, for the treatment of infectious diseases. The consumption of substandard and/or falsified antimicrobial drugs has the potential to result in treatment failure, emergence and development of Antimicrobial resistance (AMR), and ultimately patient mortality. The objective of this study is to assess the quality of four commonly used antimicrobials (ciprofloxacin, norfloxacin, and amoxicillin and its combination with clavulanic acid) marketed in Dire Dawa and Jijiga cities, and Togo-Wuchale town with high potential for illegal drug trade in Ethiopia due to porous border through Somaliland. A total of 54 different brands/products of amoxicillin, amoxicillin plus clavulanic acid, ciprofloxacin, and norfloxacin formulations were collected covertly from 43 facilities using a convenience sampling strategy from March 16 to March 29, 2022, from the selected locations. The samples were first screened using GPHF-minilab protocol and then analyzed with references to USP and BP methods. The quality evaluation showed that 14.28% (6/42) of all samples failed the GPHF-minilab screening test quantitatively, 27.27% (6/22) of amoxicillin samples failed weight variation test, and 22.73% (5/22) of amoxicillin and 40% (2/5) of amoxicillin/clavulanate products failed to meet the assay test. Furthermore, 12.96% of the samples failed the dissolution test. Overall, 22.22% of the products analyzed did not meet pharmacopoeial specifications. Additionally, 56.25% of amoxicillin samples, 60% of amoxicillin/clavulanate, 20% of ciprofloxacin, and 54.54% of norfloxacin samples were found to be pharmaceutically inequivalent with their respective comparator products in relation to dissolution profile studies. The study had shown that the quality of essential antimicrobial medicines in eastern Ethiopia is substandard. This affirms the need for regular post-market surveillance to inform on the situation of antibiotic quality in eastern Ethiopia. Based on the accumulated evidence regulatory actions and mechanisms had to be also in place to circumvent the challenge
dc.identifier.urihttps://etd.aau.edu.et/handle/123456789/2822
dc.language.isoen_US
dc.publisherAddis Ababa University
dc.subjectAntimicrobials
dc.subjectquality assessment
dc.subjectpharmaceutical equivalence
dc.subjectEastern Ethiopia
dc.titleQuality Assessment of Antimicrobial Drugs: Amoxicillin Capsules, Amoxicillin + Clavulanate, Ciprofloxacin and Norfloxacin Tablets from Drug Retail Outlets of Selected Cities in Eastern Ethiopia.
dc.typeThesis

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