Development, Characterization, and Evaluation of Potential Systemic Toxicity of a Novel Oral Melatonin Formulation

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dc.authoridOrhan, Hilmi/0000-0003-2464-1841
dc.authoridYILMAZ, ONUR/0000-0002-0992-5937
dc.contributor.authorCheaburu-Yilmaz, Catalina N.
dc.contributor.authorAtmaca, Kemal
dc.contributor.authorYilmaz, Onur
dc.contributor.authorOrhan, Hilmi
dc.date.accessioned2024-08-31T07:47:40Z
dc.date.available2024-08-31T07:47:40Z
dc.date.issued2024
dc.departmentEge Üniversitesien_US
dc.description.abstractThe need to create safe materials for biomedical and pharmaceutical applications has become a significant driving force for the development of new systems. Therefore, a chitosan-coated copolymer of itaconic acid, acrylic acid, and N-vinyl caprolactam (IT-AA-NVC) was prepared by radical polymerization and subsequent coating via nanoprecipitation to give a system capable of sustained delivery of melatonin. Although melatonin brings undoubted benefits to the human body, aspects of the optimal dose, route, and time of administration for the obtaining of suitable treatment outcomes remain under discussion. The entrapment of melatonin in biocompatible polymeric systems can prevent its oxidation, decrease its toxicity, and provide an increased half-life, resulting in an enhanced pharmacokinetic profile with improved patient compliance. The structures of the biopolymer and conjugate were proven by FTIR, thermal properties were tested by DSC, and the morphologies were followed by SEM. The loading efficiency and in vitro release profile were studied by means of HPLC, and a delayed release profile with an initial burst was obtained. The potential systemic toxicity of the formulation was studied in vivo; a mild hepatotoxicity was observed following administration of the melatonin-loaded formulation to mice, both by histopathology and blood clinical biochemistry. Histopathology showed a mild nephrotoxicity as well; however, kidney clinical biochemistry did not support this.en_US
dc.description.sponsorshipEge University Scientific Research Grants [ONAP 22922]en_US
dc.description.sponsorshipThis research was partly funded by Ege University Scientific Research Grants, project number ONAP 22922; the APC was funded by C.N.C.-Y. and O.Y., using reviewer vouchers.en_US
dc.identifier.doi10.3390/pharmaceutics16070871
dc.identifier.issn1999-4923
dc.identifier.issue7en_US
dc.identifier.pmid39065568en_US
dc.identifier.scopus2-s2.0-85199582299en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.3390/pharmaceutics16070871
dc.identifier.urihttps://hdl.handle.net/11454/104507
dc.identifier.volume16en_US
dc.identifier.wosWOS:001277614400001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherMdpien_US
dc.relation.ispartofPharmaceuticsen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.snmz20240831_Uen_US
dc.subjectChitosan Coatingen_US
dc.subjectItaconicen_US
dc.subjectN-Vinyl Caprolactamen_US
dc.subjectNanoprecipitationen_US
dc.subjectCopolymeren_US
dc.subjectMelatoninen_US
dc.subjectBiocompatibleen_US
dc.subjectSystemic Acute Toxicityen_US
dc.titleDevelopment, Characterization, and Evaluation of Potential Systemic Toxicity of a Novel Oral Melatonin Formulationen_US
dc.typeArticleen_US

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