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The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach
dc.creator | Đokić, Marija | |
dc.creator | Đuriš, Jelena | |
dc.creator | Solomun, Ljiljana | |
dc.creator | Kachrimanis, Kyriakos | |
dc.creator | Đurić, Zorica | |
dc.creator | Ibrić, Svetlana | |
dc.date.accessioned | 2019-09-02T11:40:32Z | |
dc.date.available | 2019-09-02T11:40:32Z | |
dc.date.issued | 2014 | |
dc.identifier.issn | 0263-8762 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/2159 | |
dc.description.abstract | The purpose of this study was to investigate the influence of spiral jet-milling process on the physicochemical characteristics of alpha polymorphic active pharmaceutical ingredient, using Carbamazepine form III as a model drug, and taking into consideration Quality by Design (QbD) approach to pharmaceutical development. A 2((4-1)) factorial screening design was implemented to identify the spiral jet-milling process variables that significantly affect the particle size distribution of milled samples. Diameter of injector nozzles, diameter of ring nozzles and air pressure were selected for further analysis using a 2((3-1)) factorial experimental design. Particle size distribution of additional samples was determined, while physicochemical properties were examined by differential scanning calorimetry (DSC), hot-stage polarized microscopy (HSPM), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), and compared to those of un-milled drug. The gathered results shown that applied experimental design approach is capable to predict material behavior and could help in better understanding of material behavior during jet-milling process. Created design space (DS) provides assurance of product quality, expressed as the powder particle sizes lower than 5 mu m, as well as, in initial polymorph form existence after jet-milling through combination and interaction of input variables. | en |
dc.publisher | Inst Chemical Engineers, Rugby | |
dc.relation | info:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34007/RS// | |
dc.rights | restrictedAccess | |
dc.source | Chemical Engineering Research & Design | |
dc.subject | Jet-milling | en |
dc.subject | Carbamazepine | en |
dc.subject | Factorial screening design | en |
dc.subject | Particle size | en |
dc.subject | Polymorphism | en |
dc.subject | Quality by design | en |
dc.title | The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach | en |
dc.type | article | |
dc.rights.license | ARR | |
dcterms.abstract | Соломун, Љиљана; Ђокић, Марија; Ђуриш, Јелена; Кацхриманис, Кyриакос; Ибрић, Светлана; Ђурић, Зорица; | |
dc.citation.volume | 92 | |
dc.citation.issue | 3 | |
dc.citation.spage | 500 | |
dc.citation.epage | 508 | |
dc.citation.other | 92(3): 500-508 | |
dc.citation.rank | M22 | |
dc.identifier.wos | 000333782900012 | |
dc.identifier.doi | 10.1016/j.cherd.2013.09.011 | |
dc.identifier.scopus | 2-s2.0-84894321842 | |
dc.type.version | publishedVersion |