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This study aims to investigate the potential anticancer activity of fluvastatin (FLV)\u2010SNEDs in breast cancer while comparing it with FLV in vitro as well as in vivo exploiting\/using MDA\u2010MB\u2010231 and Erhlich ascites carcinoma (EAC)\u2010bearing mice, respectively. Biochemical analysis of liver and kidney functions, oxidative stress markers, and histopathological examinations of such tumor tissues were performed showing the potentiality of SNEDs as a nanocarrier for antitumor agents. FLV\u2010SNEDs demonstrated more potent anticancer activity compared to FLV on MDA\u2010MB\u2010231 and hepatocellular carcinoma (HepG2) cells. In vivo experiments on the EAC\u2010bearing\u00a0mice\u00a0model indicated that FLV and\u2014to a greater extent\u2014FLV\u2010SNEDs ameliorated EAC\u2010induced hepatotoxicity and nephrotoxicity. FLV or FLV\u2010SNEDs evidently reduced the percent of Ki\u201067 +ve EAC cells by 57.5% and 86.5% in comparison to the vehicle\u2010treated EAC group. In addition, FLV or FLV\u2010SNEDs decreased Bcl\u20102 levels in serum and liver specimens. In contrast, FLV or FLV\u2010SNEDs significantly activated the executioner caspase\u20103. Simultaneously, both FLV and FLV\u2010SNEDs stimulated p53 signaling and modulated Bcl\u20102 protein levels in treated cells. Collectively, these results support the contribution of apoptotic cell death in mediating the anticancer activities of FLV and FLV\u2010SNEDs against murine EAC model in vivo. This study provides new understandings of how FLV and FLV\u2010SNEDs regulate EAC cell viability via upregulation of p53 signaling, and through modulation of cleaved caspase\u20103 as well as antiapoptotic Bcl\u20102 marker.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcb.30238","type":"journal-article","created":{"date-parts":[[2022,3,28]],"date-time":"2022-03-28T05:05:13Z","timestamp":1648443913000},"page":"947-963","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Preclinical activity of fluvastatin\u2010loaded self\u2010nanoemulsifying delivery system against breast cancer models: Emphasis on apoptosis"],"prefix":"10.1002","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2585-9957","authenticated-orcid":false,"given":"Hanan","family":"Elimam","sequence":"first","affiliation":[{"name":"Department of Biochemistry, Faculty of Pharmacy University of Sadat City Sadat City Egypt"},{"name":"Department of 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