Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach

The main objective of this research is to develop an immediate release Rupatadine fumarate 10 mg tablets formulation by direct compression, through a Quality by Design approach in Costa Rica. Methods: According to a Quality by Design approach; Target Product Profile, Quality Target Product Profile a...

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Detalhes bibliográficos
Autores: Castillo Henríquez, Luis, Vargas Zúñiga, Rolando, Carazo Berrocal, Gustavo, Madrigal Redondo, German, Calvo Guzmán, Briner, Baltodano Viales, Eleaneth
Formato: artículo
Fecha de publicación:2019
País:Costa Rica
Recursos:Universidad de Costa Rica
Repositorio:Kérwá
OAI Identifier:oai:kerwa.ucr.ac.cr:10669/80712
Acesso em linha:https://www.tandfonline.com/doi/full/10.1080/03639045.2019.1652637
https://hdl.handle.net/10669/80712
Access Level:acceso embargado
Palavra-chave:Antihistaminic
Direct compression
Formulation
Immediate release
Pharmaceutical Research and Development
Quality by Design
Rupatadine fumarate
Tablets
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dc.title.es_ES.fl_str_mv Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
title Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
spellingShingle Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
Castillo Henríquez, Luis
Antihistaminic
Direct compression
Formulation
Immediate release
Pharmaceutical Research and Development
Quality by Design
Rupatadine fumarate
Tablets
title_short Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
title_full Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
title_fullStr Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
title_full_unstemmed Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
title_sort Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
dc.creator.none.fl_str_mv Castillo Henríquez, Luis
Vargas Zúñiga, Rolando
Carazo Berrocal, Gustavo
Madrigal Redondo, German
Calvo Guzmán, Briner
Baltodano Viales, Eleaneth
author Castillo Henríquez, Luis
author_facet Castillo Henríquez, Luis
Vargas Zúñiga, Rolando
Carazo Berrocal, Gustavo
Madrigal Redondo, German
Calvo Guzmán, Briner
Baltodano Viales, Eleaneth
author_role author
author2 Vargas Zúñiga, Rolando
Carazo Berrocal, Gustavo
Madrigal Redondo, German
Calvo Guzmán, Briner
Baltodano Viales, Eleaneth
author2_role author
author
author
author
author
dc.subject.es_ES.fl_str_mv Antihistaminic
Direct compression
Formulation
Immediate release
Pharmaceutical Research and Development
Quality by Design
Rupatadine fumarate
Tablets
topic Antihistaminic
Direct compression
Formulation
Immediate release
Pharmaceutical Research and Development
Quality by Design
Rupatadine fumarate
Tablets
description The main objective of this research is to develop an immediate release Rupatadine fumarate 10 mg tablets formulation by direct compression, through a Quality by Design approach in Costa Rica. Methods: According to a Quality by Design approach; Target Product Profile, Quality Target Product Profile and the Critical Quality Attributes were defined. In the preformulation study, compatibility tests were carried out between the raw materials. The Critical Material Attributes were established using Quality Risk Management. Three formulation prototypes were prepared by direct compression and its Critical Process Parameters were defined. The analysis of the prototypes was realized in terms of organoleptic properties, identification, potency, content uniformity, dissolution, disintegration, friability and loss by drying. Results: All the prototypes showed a white or slightly pink surface, potency between 90.0 – 110.0% of the labeling, an acceptance value for the content uniformity lower than the specification (AV < 15), the dissolved amount of active pharmaceutical ingredient was greater than 85.0 % at 30 minutes, friability less than 1.0 %, a disintegration time less than 15 minutes and moisture content less than 2.0%. Conclusions: The approaching of a Quality by Design model to the current development allowed to obtain satisfactory results in the three formulation prototypes. The excipients to be used can be lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, pregelatinized starch, magnesium stearate, stearic acid and PVP K-30.
publishDate 2019
dc.date.issued.none.fl_str_mv 2019
dc.date.accessioned.none.fl_str_mv 2020-03-11T15:18:18Z
dc.date.available.none.fl_str_mv 2020-03-11T15:18:18Z
dc.type.none.fl_str_mv artículo original
http://purl.org/coar/resource_type/c_2df8fbb1
info:eu-repo/semantics/article
format article
dc.identifier.citation.none.fl_str_mv https://www.tandfonline.com/doi/full/10.1080/03639045.2019.1652637
dc.identifier.issn.none.fl_str_mv 0363-9045
1520-5762
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/10669/80712
dc.identifier.doi.none.fl_str_mv 10.1080/03639045.2019.1652637
url https://www.tandfonline.com/doi/full/10.1080/03639045.2019.1652637
https://hdl.handle.net/10669/80712
identifier_str_mv 0363-9045
1520-5762
10.1080/03639045.2019.1652637
dc.language.iso.es_ES.fl_str_mv en_US
language_invalid_str_mv en_US
dc.rights.none.fl_str_mv acceso embargado
http://purl.org/coar/access_right/c_f1cf
info:eu-repo/semantics/embargoedAccess
rights_invalid_str_mv acceso embargado
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eu_rights_str_mv embargoedAccess
dc.source.es_ES.fl_str_mv Drug Development and Industrial Pharmacy, vol. 45(10), pp.1674-1681
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-a331-9cdc374504d0600Carazo Berrocal, Gustavoa2d58e07-4a32-452e-929e-819ebd3a0c97600Madrigal Redondo, German87549009-dd05-4ce5-81bb-8d7ad90be88a600Calvo Guzmán, Brinerb3da0f38-8ae0-4572-8470-d828803234afBaltodano Viales, Eleanethe3bf4ae7-e48e-4d60-a6f0-35cba5d6a8d36002020-03-11T15:18:18Z2020-03-11T15:18:18Z2019https://www.tandfonline.com/doi/full/10.1080/03639045.2019.16526370363-90451520-5762https://hdl.handle.net/10669/8071210.1080/03639045.2019.1652637The main objective of this research is to develop an immediate release Rupatadine fumarate 10 mg tablets formulation by direct compression, through a Quality by Design approach in Costa Rica. Methods: According to a Quality by Design approach; Target Product Profile, Quality Target Product Profile and the Critical Quality Attributes were defined. In the preformulation study, compatibility tests were carried out between the raw materials. The Critical Material Attributes were established using Quality Risk Management. Three formulation prototypes were prepared by direct compression and its Critical Process Parameters were defined. The analysis of the prototypes was realized in terms of organoleptic properties, identification, potency, content uniformity, dissolution, disintegration, friability and loss by drying. Results: All the prototypes showed a white or slightly pink surface, potency between 90.0 – 110.0% of the labeling, an acceptance value for the content uniformity lower than the specification (AV < 15), the dissolved amount of active pharmaceutical ingredient was greater than 85.0 % at 30 minutes, friability less than 1.0 %, a disintegration time less than 15 minutes and moisture content less than 2.0%. Conclusions: The approaching of a Quality by Design model to the current development allowed to obtain satisfactory results in the three formulation prototypes. The excipients to be used can be lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, pregelatinized starch, magnesium stearate, stearic acid and PVP K-30.Universidad de Costa Rica/[]/UCR/Costa RicaUCR::Vicerrectoría de Docencia::Salud::Facultad de FarmaciaUCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR)en_USacceso embargadohttp://purl.org/coar/access_right/c_f1cfinfo:eu-repo/semantics/embargoedAccessDrug Development and Industrial Pharmacy, vol. 45(10), pp.1674-1681reponame:Kérwáinstname:Universidad de Costa Ricainstacron:UCRAntihistaminicDirect compressionFormulationImmediate releasePharmaceutical Research and DevelopmentQuality by DesignRupatadine fumarateTabletsDevelopment of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approachartículo originalhttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleORIGINALDevelopment of immediate release Rupatadine.pdfDevelopment of immediate release Rupatadine.pdfArtículo principalapplication/pdf785310https://www.kerwa.ucr.ac.cr/bitstreams/29789376-24d2-40ad-8f34-ed96275cb18c/downloadec0ec3898201aedbadc6709c30b6da94MD54LICENSElicense.txtlicense.txttext/plain; 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