Quality evaluation of selected expired fluoroquinolones medicines obtained from the public hospitals in Jimma zone, Oromia regional state, Ethiopia.

Background: 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. Methods: 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. Results: The finding revealed that about 100% (7/7) expired samples passed pharmacopeia 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 min. 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%). Conclusion: 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.

Modeling and comparison of dissolution profiles for different brands of albendazole boluses.

BACKGROUND: Addressing critical veterinary drugs, especially drugs with solubility problems like albendazole, and their implications for therapeutic efficacy, in-vitro dissolution studies can indeed provide valuable insights into how different brands of albendazole boluses perform under standardized conditions, helping to assess their dissolution profiles and potential bioavailability. METHODS: Six brands of albendazole 300 mg boluses were collected from December 2020 to May 2021 G.C. The laboratory work was conducted from December 2020 to May 2021 in the National Animal Products and Veterinary Drugs and Feed Quality Assessment Centre (APVD-FQAC) laboratories. The collected brands from government veterinary clinics and private veterinary shops were subjected to model independent and dependent parameters. The dissolution test was conducted according to the USP monograph. RESULTS: The study found that none of the six brands met the requirements of the dissolution test, as their API release was less than 80% within the specified 60-minute timeframe according to USP standards. Model independence indicated that only one brand (Alb002 = 3.72) achieved a difference factor of ≤ 15%. The remaining four brands (4/6) did not meet this criterion. However, the similarity factor (f2) revealed that all five brands (5/6) were comparable to the comparator products, with f2 values of [Formula: see text]50%. The mean dissolution time results confirmed that three brands (3/6) had the highest dissolution rate and the fastest onset of action. The model-dependent kinetics indicated that the Weibull and Korsemeyer-Peppas models were the best fit for the release of drug substances. CONCLUSION: The study highlights issues with albendazole boluses' quality, highlighting the need for national in-vitro dissolution studies. These recommendations could improve quality control, streamline regulatory frameworks, and offer practical, cost-effective methods for evaluating drug efficacy and safety, ensuring veterinary pharmaceuticals meet safety and efficacy standards.

Traditional herbal medicine regulatory implementation in Ethiopia: a qualitative study.

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia.

BACKGROUND: Azithromycin is a therapeutically" relevant macrolide antibiotic registered on the Essential Medicines List of the World Health Organization. The fact that medicine is selected as an essential drug doesn't mean that it is of good quality. Hence, a continuous quality evaluation of the drug should be mandated to verify that the right medication is available on the market. OBJECTIVE: To evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia. METHODS: All six brands were subjected to in-vitro quality control tests, which were carried out according to procedures described in the manufacturer's method, the United States Pharmacopeia, and the WHO inspection tool. All quality control parameters were compared by one-way ANOVA. Statistically, significant difference was considered when P<0.05. The in-vitro dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches. RESULTS: All of the evaluated brands agreed with WHO visual inspection criteria. All of the tablets achieved the thickness, and diameter test requirements of the manufacturer's specification (±5%). All brands passed the hardness, friability, weight variation, disintegration, identity, and assay tests as stipulated by USP. The dissolution rate was more than 80% in 30 minutes, which was within the USP specification. The model-independent parameters have confirmed that only two brands (2/6) were deemed better brands for interchangeability. Weibull and Korsemeyer's Peppas model were the best release models. CONCLUSION: All of the evaluated brands passed the quality specification. The model dependent approaches revealed that drug release data fit well to the Weibull, and Korsemeyer's Peppas release models. However, the model-independent parameters have confirmed that only two brands were deemed better brands (2/6) for interchangeability. Due to the dynamic nature of low-quality medications, the Ethiopian Food, and Drug Authority should keep an eye on marketed products to guarantee their quality, especially for drugs like azithromycin for which non-bioequivalence data from the study has revealed a clinical concern.