Yesuneh T. Mekasha ^1* Habtamu Getahun ² Sileshi Belew ³ Gemmechu Hasen ³ Guta Tefera ⁴ Sultan Suleman ³

• ¹ Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, Amhara Regional State, Ethiopia, Gondar, Ethiopia
• ² Pharmaceutical Quality Assurance and Regulatory Affairs, Oromia Regional Health Bureau, Oromia Regional State, Ethiopia,, Addis Ababa, Ethiopia
• ³ Institute of Health, Jimma University, Jimma, Oromia Region, Ethiopia
• ⁴ Wolkite University, Wolkite, Southern Nations, Nationalities, and Peoples' Region, Ethiopia

The problem of medicine expiration presents a notable obstacle, resulting in considerable financial losses. Nevertheless, there is currently limited data indicating that certain medications do not experience a significant decrease in effectiveness after their expiration date. Therefore, the aim of the study was to assess the Physico-chemical quality of expired fluoroquinolone antibiotics.The expired samples of fluoroquinolone antibiotics were purposively collected from public hospitals in the Jimma zone of the Oromia regional state, Ethiopia. A World Health Organization quality evaluation sampling strategy was employed. Then, simple random sampling techniques were utilized for the selection of tablets for the laboratory quality control test. The assay, identification, and dissolution were performed in accordance with the United States Pharmacopeia (USP) guidelines, as well as Failure Mode and Effect Analysis (FMEA) techniques.The finding revealed that about 100% (7/7) expired samples passed pharmacopoeia quality specifications for identity and assay tests. However, of the seven expired brands, about 14.3% (1/7) of the sample (Code-002) was unable to release its API content within the USP criteria of 30 minutes. The risk-based quality evaluation revealed that assay was the most critical quality attributed to ciprofloxacin tablets (RPN = 189), followed by identity (RPN = 100). Assay was also the most critical quality attribute (RPN = 378), followed by identity (RPN = 100) for Norfloxacin tablets. The risk-based desirability function approach showed that 75% (3/4) of ciprofloxacin products were of good quality, and 25% (1) were found to be of acceptable quality, while the desirability function of norfloxacin tablets was found to be excellent 1 (33.3%), good 1 (33.3%), and acceptable 1 (33.3%).The study revealed that medications can maintain their quality beyond their labeled expiration date. By combining pharmacopeial standards with risk-based approaches like Failure Mode and Effect Analysis (FMEA), the study provides a comprehensive evaluation framework. This approach not only confirms the continued effectiveness of expired fluoroquinolone antibiotics but also underscores the potential waste reduction and cost-saving benefits. This could significantly contribute to addressing healthcare challenges in low-resource settings, promoting more efficient pharmaceutical resource utilization.