dc.creator | Abreu Villela, Renata | es |
dc.creator | Schönenberger, Monica | es |
dc.creator | Caraballo Rodríguez, Isidoro | es |
dc.creator | Kuentz, Martin | es |
dc.date.accessioned | 2024-04-04T08:20:14Z | |
dc.date.available | 2024-04-04T08:20:14Z | |
dc.date.issued | 2018-12 | |
dc.identifier.citation | Abreu Villela, R., Schönenberger, M., Caraballo Rodríguez, I. y Kuentz, M. (2018). Early stages of drug crystallization from amorphous solid dispersion via fractal analysis based on chemical imaging. European Journal of Pharmaceutics and Biopharmaceutics, 133, 122-130. https://doi.org/10.1016/j.ejpb.2018.10.007. | |
dc.identifier.issn | 0939-6411 | es |
dc.identifier.issn | 1873-3441 | es |
dc.identifier.uri | https://hdl.handle.net/11441/156658 | |
dc.description.abstract | Early stages of crystallization from amorphous solid dispersion (ASD) are typically not detected by means of standard methods like powder X-ray diffraction (XRPD). The aim of this study is therefore to evaluate if fractal analysis based on energy dispersive X-ray imaging can provide the means to identify early signs of physical instability. ASDs of the poorly water-soluble compound, felodipine (FEL) were prepared by solvent evaporation using different grades of HPMCAS, at 50 wt% drug loading. Samples were stored at accelerated conditions of 40 °C. Scanning electron microscopy equipped with an energy-dispersive X-ray spectroscopy (SEM-EDS) was used for elemental mapping of tablet surfaces. Comparative data were generated with a standard XRPD and with more sensitive methods for detection of early instability, i.e. laser scanning confocal microscopy (LSM) and atomic force microscopy (AFM). The SEM-EDS identified changes of drug-rich domains that were confirmed by LSM and AFM. Early changes in drug clusters were also revealed by a multifractal analysis that indicated a beginning phase separation and drug crystallization. Therefore, the presented fractal cluster analysis based on chemical imaging bears much promise as a new method to detect early signs of physical instability in ASD, which is of great relevance for pharmaceutical development. | es |
dc.description.sponsorship | Ministry of Education of Brazil (CAPES) grant number 99999.001486 | es |
dc.description.sponsorship | Spanish Ministry of Economy and Competitiveness and FEDER Funds (EuropeanUnion) MAT2016-77345-C3-3-P | es |
dc.format | application/pdf | es |
dc.format.extent | 9 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | European Journal of Pharmaceutics and Biopharmaceutics, 133, 122-130. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Solid dispersion | es |
dc.subject | Amorphous drug | es |
dc.subject | Phase separation | es |
dc.subject | Crystallization | es |
dc.subject | Chemical imaging | es |
dc.subject | Multifractal analysis | es |
dc.title | Early stages of drug crystallization from amorphous solid dispersion via fractal analysis based on chemical imaging | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/acceptedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Farmacia y Tecnología Farmacéutica | es |
dc.relation.projectID | 99999.001486 | es |
dc.relation.projectID | MAT2016-77345-C3-3-P | es |
dc.relation.publisherversion | https://dx.doi.org/10.1016/j.ejpb.2018.10.007 | es |
dc.identifier.doi | 10.1016/j.ejpb.2018.10.007 | es |
dc.journaltitle | European Journal of Pharmaceutics and Biopharmaceutics | es |
dc.publication.volumen | 133 | es |
dc.publication.initialPage | 122 | es |
dc.publication.endPage | 130 | es |
dc.contributor.funder | Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior. Brasil | es |
dc.contributor.funder | Ministerio de Economía y Competitividad (MINECO). España | es |
dc.contributor.funder | European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER) | es |
dc.description.awardwinning | Premio Mensual Publicación Científica Destacada de la US. Facultad de Farmacia | |