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Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets

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Date
2019-11-08
Author
Castillo Henríquez, Luis
Vargas Zúñiga, Rolando
Madrigal Redondo, German
Carazo Berrocal, Gustavo
Hanley Vargas, Georgia
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Abstract
The 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.
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http://hdl.handle.net/10669/81174
External link to the item
10.36347/SAJP.2019.v08i11.001
https://www.semanticscholar.org/paper/Determination-of-the-Impact-Caused-by-Direct-on-the-Henríquez-Zúñiga/e8d63a66492192dd636ce30a9d4b5b0bed8af27a
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  • Repositorios universitarios

  • Repositorio del SIBDI-UCR
  • Biblioteca Digital del CIICLA
  • Repositorio Documental Rafael Obregón Loría (CIHAC)
  • Biblioteca Digital Carlos Melendez (CIHAC)
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  • Colección de videos de UPA-VAS
  • Sitios recomendados

  • Buscador regional de LA Referencia
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  • Scientific Electronic Library Online (SciELO)
  • Directory of Open Access Journals (DOAJ)
  • Redalyc
  • Redes sociales

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Contact Us | Send Feedback
Repositorio Institucional de la Universidad de Costa Rica. Algunos derechos reservados. Este repositorio funciona con DSpace.
Universidad de Costa Rica