dc.creatorCastillo Henríquez, Luis
dc.creatorVargas Zúñiga, Rolando
dc.creatorMadrigal Redondo, German
dc.creatorCarazo Berrocal, Gustavo
dc.creatorHanley Vargas, Georgia
dc.date.accessioned2020-06-18T19:59:48Z
dc.date.accessioned2022-10-20T00:23:36Z
dc.date.available2020-06-18T19:59:48Z
dc.date.available2022-10-20T00:23:36Z
dc.date.created2020-06-18T19:59:48Z
dc.date.issued2019-11-08
dc.identifierhttps://www.semanticscholar.org/paper/Determination-of-the-Impact-Caused-by-Direct-on-the-Henríquez-Zúñiga/e8d63a66492192dd636ce30a9d4b5b0bed8af27a
dc.identifier2347-9531
dc.identifier2320-4206
dc.identifierhttps://hdl.handle.net/10669/81174
dc.identifier10.36347/SAJP.2019.v08i11.001
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/4532930
dc.description.abstractThe aim of this study is to determine the impact caused by direct compression on the crystalline state of two prototypes of Rupatadine fumarate 10 mg tablets. The tablets were manufactured through direct compression. Five grams powdered tablets samples were taken randomly for analysis through DSC, TGA and XRD. The results were analyzed by making a comparison between their crystalline characterization and the one shown by the active pharmaceutical ingredient, excipients, the placebo and the powdered formula before compression. The active pharmaceutical ingredient showed a melting point at 201.38 °C, which decreased 2 – 3 °C in the tablets’ thermograms. Placebos presented an endotherm at 228 °C characteristic of amorphous lactose’s melting point. The only thermal change presented between the tablets and the other samples is the crystallization of amorphous lactose around 172 – 176 °C. X-ray diffractograms showed an increased intensity for the peaks of α - lactose monohydrate after compression and no changes regarding the active pharmaceutical ingredient. The comparison done between the analyses, confirmed that compression didn’t impact the crystalline state of Rupatadine fumarate. However mechanical treatment and the influence of the excipients caused the fusion peak to shift towards lower temperatures. Lactose’s crystal lattice suffered the greatest impact caused by compression, which generated the crystallization of the amorphous region present in that raw material. Nevertheless, such modification doesn’t alter the prototypes’ aptitude for being developed into a final solid pharmaceutical form and it is not a situation that affects the product’s quality.
dc.languageen_US
dc.sourceScholars Academic Journal of Pharmacy, vol. 8(11), pp.465-472
dc.subjectCompression impact
dc.subjectCrystallization
dc.subjectDirect compression
dc.subjectPolymorphism
dc.subjectRupatadine fumarate
dc.subjectTablet
dc.titleDetermination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
dc.typeartículo científico


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