Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method

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dc.contributor.authorAmasya, Gülin
dc.contributor.authorBadilli, Ulya
dc.contributor.authorAksu, Buket
dc.contributor.authorTarımcı, Nilufer
dc.date.accessioned2021-05-15T12:37:14Z
dc.date.available2021-05-15T12:37:14Z
dc.date.issued2016
dc.departmentEczacılık Fakültesien_US
dc.descriptionAksu, Buket/0000-0001-7555-0603; Amasya, Gulin/0000-0002-0491-450X
dc.description.abstractWith Quality by Design (QbD), a systematic approach involving design and development of all production processes to achieve the final product with a predetermined quality, you work within a design space that determines the critical formulation and process parameters. Verification of the quality of the final product is no longer necessary. In the current study, the QbD approach was used in the preparation of lipid nanoparticle formulations to improve skin penetration of 5-Fluorouracil, a widely-used compound for treating non-melanoma skin cancer. 5-Fluorouracil-loaded lipid nanoparticles were prepared by the W/O/W double emulsion - solvent evaporation method. Artificial neural network software was used to evaluate the data obtained from the lipid nanoparticle formulations, to establish the design space, and to optimize the formulations. Two different artificial neural network models were developed. The limit values of the design space of the inputs and outputs obtained by both models were found to be within the knowledge space. The optimal formulations recommended by the models were prepared and the critical quality attributes belonging to those formulations were assigned. The experimental results remained within the design space limit values. Consequently, optimal formulations with the critical quality attributes determined to achieve the Quality Target Product Profile were successfully obtained within the design space by following the QbD steps. (C) 2016 Elsevier B.V. All rights reserved.en_US
dc.description.sponsorshipAnkara University Scientific Research Projects CoordinationAnkara University [13L3336003]en_US
dc.description.sponsorshipThis work was supported by Ankara University Scientific Research Projects Coordination, (13L3336003).en_US
dc.identifier.doi10.1016/j.ejps.2016.01.003
dc.identifier.endpage102en_US
dc.identifier.issn0928-0987
dc.identifier.issn1879-0720
dc.identifier.pmid26780593
dc.identifier.scopus2-s2.0-84955511110
dc.identifier.scopusqualityQ1
dc.identifier.startpage92en_US
dc.identifier.urihttps://doi.org/10.1016/j.ejps.2016.01.003
dc.identifier.urihttps://hdl.handle.net/20.500.12939/499
dc.identifier.volume84en_US
dc.identifier.wosWOS:000370680200011
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorAksu, Buket
dc.language.isoen
dc.publisherElsevier Science Bven_US
dc.relation.ispartofEuropean Journal of Pharmaceutical Sciences
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectQuality By Design (QbD)en_US
dc.subjectLipid Nanoparticlesen_US
dc.subjectArtificial Neural Networksen_US
dc.subject5-Fluorouracilen_US
dc.subjectNon-Melanoma Skin Canceren_US
dc.titleQuality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method
dc.typeArticle

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