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

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, T...

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Detalles Bibliográficos
Autores: Castillo Henríquez, Luis, Vargas Zúñiga, Rolando, Madrigal Redondo, German, Carazo Berrocal, Gustavo, Hanley Vargas, Georgia
Tipo de recurso: artículo
Fecha de publicación:2019
País:Costa Rica
Institución:Universidad de Costa Rica
Repositorio:Kérwá
OAI Identifier:oai:kerwa.ucr.ac.cr:10669/81174
Acceso en línea:https://www.semanticscholar.org/paper/Determination-of-the-Impact-Caused-by-Direct-on-the-Henríquez-Zúñiga/e8d63a66492192dd636ce30a9d4b5b0bed8af27a
https://hdl.handle.net/10669/81174
Access Level:acceso abierto
Palabra clave:Compression impact
Crystallization
Direct compression
Polymorphism
Rupatadine fumarate
Tablet
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dc.title.es_ES.fl_str_mv Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
title Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
spellingShingle Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
Castillo Henríquez, Luis
Compression impact
Crystallization
Direct compression
Polymorphism
Rupatadine fumarate
Tablet
title_short Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
title_full Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
title_fullStr Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
title_full_unstemmed Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
title_sort Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
dc.creator.none.fl_str_mv Castillo Henríquez, Luis
Vargas Zúñiga, Rolando
Madrigal Redondo, German
Carazo Berrocal, Gustavo
Hanley Vargas, Georgia
author Castillo Henríquez, Luis
author_facet Castillo Henríquez, Luis
Vargas Zúñiga, Rolando
Madrigal Redondo, German
Carazo Berrocal, Gustavo
Hanley Vargas, Georgia
author_role author
author2 Vargas Zúñiga, Rolando
Madrigal Redondo, German
Carazo Berrocal, Gustavo
Hanley Vargas, Georgia
author2_role author
author
author
author
dc.subject.es_ES.fl_str_mv Compression impact
Crystallization
Direct compression
Polymorphism
Rupatadine fumarate
Tablet
topic Compression impact
Crystallization
Direct compression
Polymorphism
Rupatadine fumarate
Tablet
description 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.
publishDate 2019
dc.date.issued.none.fl_str_mv 2019-11-08
dc.date.accessioned.none.fl_str_mv 2020-06-18T19:59:48Z
dc.date.available.none.fl_str_mv 2020-06-18T19:59:48Z
dc.type.none.fl_str_mv artículo original
http://purl.org/coar/resource_type/c_2df8fbb1
info:eu-repo/semantics/article
format article
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dc.identifier.issn.none.fl_str_mv 2347-9531
2320-4206
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/10669/81174
dc.identifier.doi.none.fl_str_mv 10.36347/SAJP.2019.v08i11.001
url https://www.semanticscholar.org/paper/Determination-of-the-Impact-Caused-by-Direct-on-the-Henríquez-Zúñiga/e8d63a66492192dd636ce30a9d4b5b0bed8af27a
https://hdl.handle.net/10669/81174
identifier_str_mv 2347-9531
2320-4206
10.36347/SAJP.2019.v08i11.001
dc.language.iso.es_ES.fl_str_mv en_US
language_invalid_str_mv en_US
dc.rights.none.fl_str_mv acceso abierto
http://purl.org/coar/access_right/c_abf2
info:eu-repo/semantics/openAccess
rights_invalid_str_mv acceso abierto
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.source.es_ES.fl_str_mv Scholars Academic Journal of Pharmacy, vol. 8(11), pp.465-472
dc.source.none.fl_str_mv reponame:Kérwá
instname:Universidad de Costa Rica
instacron:UCR
instname_str Universidad de Costa Rica
instacron_str UCR
institution UCR
reponame_str Kérwá
collection Kérwá
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spelling Castillo Henríquez, Luisb0d10d39-da2d-4270-841f-ae3e3c38445bVargas Zúñiga, Rolandod66b2ad2-5b4a-4c20-a331-9cdc374504d0600Madrigal Redondo, German87549009-dd05-4ce5-81bb-8d7ad90be88a600Carazo Berrocal, Gustavoa2d58e07-4a32-452e-929e-819ebd3a0c97600Hanley Vargas, Georgia87f01512-f399-443d-a520-17dd0afe86122020-06-18T19:59:48Z2020-06-18T19:59:48Z2019-11-08https://www.semanticscholar.org/paper/Determination-of-the-Impact-Caused-by-Direct-on-the-Henríquez-Zúñiga/e8d63a66492192dd636ce30a9d4b5b0bed8af27a2347-95312320-4206https://hdl.handle.net/10669/8117410.36347/SAJP.2019.v08i11.001The 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.UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)en_USacceso abiertohttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessScholars Academic Journal of Pharmacy, vol. 8(11), pp.465-472reponame:Kérwáinstname:Universidad de Costa Ricainstacron:UCRCompression impactCrystallizationDirect compressionPolymorphismRupatadine fumarateTabletDetermination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tabletsartículo originalhttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleORIGINALDetermination_of_the_Impact_Caused_by_Direct_Compression_on_the.pdfDetermination_of_the_Impact_Caused_by_Direct_Compression_on_the.pdfDocumento completoapplication/pdf545383https://www.kerwa.ucr.ac.cr/bitstreams/795f6233-7f4a-47a6-b578-d794e8684d1d/download7bcd485749d71910b4d6dcbac981de6aMD51LICENSElicense.txtlicense.txttext/plain; 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