In-vitro release study of racecadotril from granule sachets: influence of brij-35

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dc.contributor.authorÇakır, Onur
dc.contributor.authorUğraş, Halil İbrahim
dc.contributor.authorToksöz, Yavuz Selim
dc.contributor.authorGüleli, Müge
dc.contributor.authorÇalışkan, Cem
dc.date.accessioned2024-06-13T20:18:29Z
dc.date.available2024-06-13T20:18:29Z
dc.date.issued2023
dc.departmentFakülteler, Mühendislik Fakültesi, Metalurji ve Malzeme Mühendisliği Bölümü
dc.description.abstractFor sachet drug forms containing Racecadotril, which are freely soluble in methanol and methylene chloride but practically insoluble in water, used as an anti-diarrhea, suitable dissolution media meeting the parameters requested by the authorities are not available in the literature and monographs. For this reason, a suitable dissolution medium was determined in accordance with the guidelines and the dissolution profiles of reference product and samples used in the study. The profiles were compared, and the method was validated. In order to determine the most suitable medium for the release of drug product, in vitro dissolution tests were performed in media prepared by different buffers similar to the pH of the gastrointestinal tract (GIT) and media containing Brij 35. In this context, the effects of buffers, pH, and different surfactants were evaluated, and it was found that Polyoxyethylene 23 lauryl ether (Brij-35), a nonionic surfactant, increased the solubility. The results were obtained with RP-HPLC method using Kromasil C18 150 mm x 4.6 mm, 5 mu m column with a flow rate of 1.5 ml/min at 210 nm wavelength in 7 minutes for Racecadotril, which dissolves at least 60% of the label value after 45 minutes after the dissolution studies performed with a type II apparatus at 37 degrees C. A suitable dissolution medium was found for sachet drug forms containing Racecadotril, and the analytical method was validated in accordance with the ICH Q2 (R1) guideline. In addition, the difference factor (f(1)) and similarity factor (f(2)) were calculated to compare the dissolution profiles of the reference product and samples in this determined dissolution medium.
dc.description.sponsorshipmanagement of World Medicine Ilac San. ve Tic. A.S (Istanbul, Turkiye)
dc.identifier.doi10.25135/jcm.91.2307.2837
dc.identifier.endpage180
dc.identifier.issn1307-6183
dc.identifier.issue2
dc.identifier.scopus2-s2.0-85171597455
dc.identifier.scopusqualityQ3
dc.identifier.startpage170
dc.identifier.urihttps://doi.org/10.25135/jcm.91.2307.2837
dc.identifier.urihttps://hdl.handle.net/11501/1393
dc.identifier.volume17
dc.identifier.wosWOS:001067792600001
dc.identifier.wosqualityQ3
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorÇakır, Onur
dc.institutionauthorUğraş, Halil İbrahim
dc.institutionauthorid0000-0002-6686-371X
dc.institutionauthorid0000-0002-1633-967X
dc.language.isoen
dc.publisherACG Publications
dc.relation.ispartofJournal of Chemical Metrology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectRacecadotril
dc.subjectDissolution Medium
dc.subjectBrij-35
dc.subjectDissolution Rate Validation
dc.subjectSink Condition
dc.titleIn-vitro release study of racecadotril from granule sachets: influence of brij-35
dc.typeArticle

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