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dc.contributor.authorLoughrey, Jonathan-
dc.date.accessioned2020-02-11T07:36:11Z-
dc.date.available2020-02-11T07:36:11Z-
dc.date.issued2019-
dc.identifier.issn1543-2521-
dc.identifier.issn2150-7376 (e)-
dc.identifier.otherBBKH693-
dc.identifier.urihttp://thuvienso.vanlanguni.edu.vn/handle/Vanlang_TV/15140-
dc.descriptionPharmaceutical Technology APIs, Excipients, and manufacturing 2019vi
dc.description.abstractLocating and understanding hydrated forms of an API As discussed, facile hydrate formation can drastically alter the processability, stability, and aqueous solubility of a given API; this example shows how an API was fully characterized to allow the development of a reliable method for synthesis, avoiding an undesirable hemi-hydrated form that was uncovered during a polymorph screening project. [...]thermal gravimetric analysis (TGA) confirmed the anhydrous, non-solvated nature of the form, while analysis by dynamic vapor sorption (DVS) at 25 °C, showed minor hysteresis with a maximum mass uptake of 0.95 wt.% at 90% relative humidity (RH), confirming its status as a developable form (Figure 1). Using the non-random two-liquid (NRTL) equation and measured water activity, a detailed hydration map was investigated across multiple organic solvents; it was found that the morphology of Form 1 was greatly improved using small volume aliquots of water in ICH class 3 solvents (e.g., 0.5 Aw = 95 % isopropanol : 5 % water, % v/v) to minimize the risk of hemi-hydrate formation.vi
dc.language.isoenvi
dc.publisherMultiMedia Healthcare Inc.vi
dc.subjectPhase transitionsvi
dc.subjectCrystallizationvi
dc.subjectHumidityvi
dc.subjectManufacturingvi
dc.subjectHydrationvi
dc.subjectDesign of experimentsvi
dc.subjectSolventsvi
dc.subjectMorphologyvi
dc.subjectPolymorphismvi
dc.subjectBioavailabilityvi
dc.titleUncovering Hidden Risks in Solid-State API Propertiesvi
dc.typeWorking Papervi
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