{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T07:00:14Z","timestamp":1782025214758,"version":"3.54.5"},"reference-count":60,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T00:00:00Z","timestamp":1677715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Azithromycin is a therapeutically\u201d 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\u2019t 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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Objective<\/jats:title>\n<jats:p>To evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Methods<\/jats:title>\n<jats:p>All six brands were subjected to <jats:italic>in-vitro<\/jats:italic> quality control tests, which were carried out according to procedures described in the manufacturer\u2019s 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&lt;0.05. The <jats:italic>in-vitro<\/jats:italic> dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Results<\/jats:title>\n<jats:p>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\u2019s specification (\u00b15%). 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\u2019s Peppas model were the best release models.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>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\u2019s 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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0282156","type":"journal-article","created":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T18:29:21Z","timestamp":1677781761000},"page":"e0282156","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":10,"title":["Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2225-7088","authenticated-orcid":true,"given":"Yesuneh Tefera","family":"Mekasha","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belachew Umeta","family":"Chali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anbessa Bekele","family":"Feissa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1693-0240","authenticated-orcid":true,"given":"Gemmechu Hasen","family":"Godena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassen Kebede","family":"Hassen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sultan Suleman","family":"Wega","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,3,2]]},"reference":[{"issue":"3","key":"pone.0282156.ref001","doi-asserted-by":"crossref","first-page":"261","DOI":"10.15557\/PiMR.2020.0048","article-title":"Azithromycin: More Than Antibiotics","volume":"16","author":"AJ Sybilski","year":"2020","journal-title":"Pediatr Med Rodz"},{"key":"pone.0282156.ref002","first-page":"1","article-title":"Predictors of chronic obstructive pulmonary diseases exacerbation reduction in response to daily Azithromycin Therapy","author":"MK Han","year":"2014","journal-title":"AM j Respir Crit Care Meds"},{"issue":"4","key":"pone.0282156.ref003","first-page":"551","article-title":"Clinical applications of azithromycin microspheres in respiratory tract infections","volume":"2","author":"F Blasi","year":"2007","journal-title":"Int J Nanomedicine"},{"issue":"1","key":"pone.0282156.ref004","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1007\/s12070-011-0437-x","article-title":"Azithromycin in Acute Bacterial Upper Respiratory Tract Infections: An Indian Non-Interventional Study","volume":"66","author":"S Donde","year":"2014","journal-title":"Indian J Otolaryngol Head Neck Surg"},{"issue":"2","key":"pone.0282156.ref005","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1093\/chromsci\/48.2.86","article-title":"Analysis of Azithromycin and Its Related Compounds by RP-HPLC with UV Detection","volume":"48","author":"F Al-rimawi","year":"2010","journal-title":"J Chromatogr Sci"},{"issue":"7","key":"pone.0282156.ref006","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.18203\/2319-2003.ijbcp20172548","article-title":"In-vitro study of quality control parameters of three different brands of azithromycin tablets","volume":"6","author":"R Singh","year":"2017","journal-title":"Int J Basic Clin Pharmacol"},{"key":"pone.0282156.ref007","unstructured":"Bolla P. 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