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dc.contributor.authorHenriet, Theo
dc.contributor.authorGana, Inès
dc.contributor.authorGhaddar, Carine
dc.contributor.authorBarrio Casado, María del
dc.contributor.authorCartigny, Yohann
dc.contributor.authorYagoubi, Najet
dc.contributor.authorDo, Bernard
dc.contributor.authorTamarit Mur, José Luis
dc.contributor.authorRietveld, Ivo B.
dc.contributor.otherUniversitat Politècnica de Catalunya. Departament de Física
dc.date.accessioned2017-01-31T09:15:09Z
dc.date.available2017-01-31T09:15:09Z
dc.date.issued2016-09-10
dc.identifier.citationHenriet, T., Gana, I., Ghaddar, C., Del Barrio, M., Cartigny, Y., Yagoubi, N., Do, B., Tamarit, J. Ll., Rietveld, Ivo B. Solid state stability and solubility of triethylenetetramine dihydrochloride. "International journal of pharmaceutics", 10 Setembre 2016, vol. 511, núm. 1, p. 312-321.
dc.identifier.issn0378-5173
dc.identifier.urihttp://hdl.handle.net/2117/100349
dc.description.abstractThe API triethylenetetramine dihydrochloride used as an alternative treatment of Wilson¿s disease is sensitive to water and it exhibits polymorphism. As this may become an issue for the drug formulation, the physical stability has been studied by differential scanning calorimetry, high-pressure thermal analysis, dynamic vapor sorption, and X-ray diffraction as a function of temperature. In addition, high-pressure liquid chromatography and mass spectrometry have been used to study the purity and chemical stability of the API. A pressure-temperature phase diagram of the pure compound has been constructed and it can be concluded that form II is monotropic in relation to form I, which is the only stable solid. The solubilities of the different solid forms have been determined with the help of a temperature ¿ composition phase diagram. The API is very soluble, at 20° C about 10% of the saturated solution with respect to the dihydrate consists of API and the solubility of the pure form I is twice as high. Moreover, it has been shown that at 20 °C, a relative humidity above 40% induces the formation of the dihydrate and at 70% a saturated solution appears. At higher temperatures, the formation of the dihydrate appears at lower relative humidity values. A clear link has been established between the API¿s chemical stability, its physical stability and the relative humidity in the air. Humidity levels above 40% are detrimental to the quality of the API.
dc.format.extent10 p.
dc.language.isoeng
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
dc.subjectÀrees temàtiques de la UPC::Física
dc.subject.lcshPharmaceutical chemistry
dc.subject.otherPhase behavior
dc.subject.otherPhysical stability
dc.subject.otherChemical stability
dc.subject.otherThermodynamics
dc.subject.otherWater vapor
dc.subject.otherPhase diagram
dc.subject.otherPhase equilibrium
dc.titleSolid state stability and solubility of triethylenetetramine dihydrochloride
dc.typeArticle
dc.subject.lemacQuímica farmacèutica
dc.contributor.groupUniversitat Politècnica de Catalunya. GCM - Grup de Caracterització de Materials
dc.identifier.doi10.1016/j.ijpharm.2016.06.140
dc.relation.publisherversionhttp://www.sciencedirect.com/science/article/pii/S0378517316306305
dc.rights.accessOpen Access
drac.iddocument19332604
dc.description.versionPostprint (author's final draft)
upcommons.citation.authorHenriet, T.; Gana, I.; Ghaddar, C.; Del Barrio, M.; Cartigny, Y.; Yagoubi, N.; Do, B.; Tamarit, J. Ll.; Rietveld, Ivo B.
upcommons.citation.publishedtrue
upcommons.citation.publicationNameInternational journal of pharmaceutics
upcommons.citation.volume511
upcommons.citation.number1
upcommons.citation.startingPage312
upcommons.citation.endingPage321


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