Application of quality by design (qbd) to reformulation of chewable tablets

This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study. In this way, product formulation and preparation procedure were reformulated. The starting point was the definition of t...

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Autores:
Rocha Saleme, Héctor
Cuadro Julio, Jorge Enrique
Mora Huertas, Claudia Elizabeth
Tipo de recurso:
Article of journal
Fecha de publicación:
2013
Institución:
Universidad Nacional de Colombia
Repositorio:
Universidad Nacional de Colombia
Idioma:
spa
OAI Identifier:
oai:repositorio.unal.edu.co:unal/49326
Acceso en línea:
https://repositorio.unal.edu.co/handle/unal/49326
http://bdigital.unal.edu.co/42783/
http://bdigital.unal.edu.co/42783/2/
Palabra clave:
calidad basada en el diseño
gestión del riesgo
diseño estadístico experimental
formulación
tabletas masticables
Quality by Design (QbD)
risk management
statistical experimental design
formulation
chewable tablets
Rights
openAccess
License
Atribución-NoComercial 4.0 Internacional
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oai_identifier_str oai:repositorio.unal.edu.co:unal/49326
network_acronym_str UNACIONAL2
network_name_str Universidad Nacional de Colombia
repository_id_str
spelling Atribución-NoComercial 4.0 InternacionalDerechos reservados - Universidad Nacional de Colombiahttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Rocha Saleme, Héctorb699b015-ac0c-4018-ad22-6c19217940ce300Cuadro Julio, Jorge Enriqueb9b0ff80-0222-46d1-bf2b-c31c4152043d300Mora Huertas, Claudia Elizabeth17a1db90-5629-4a1b-9d93-e95616a858ee3002019-06-29T08:35:36Z2019-06-29T08:35:36Z2013https://repositorio.unal.edu.co/handle/unal/49326http://bdigital.unal.edu.co/42783/http://bdigital.unal.edu.co/42783/2/This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study. In this way, product formulation and preparation procedure were reformulated. The starting point was the definition of the product quality profile from which the critical quality attributes were identified. Also, the impact and the criticality of each stage of manufacture for the product were examined regarding to their influence in achieving the critical quality attributes. Risk assessment was made for critical manufacture stages and considering the results, mitigation strategies were proposed and implemented. This leads to a formulation satisfying the requirements for the organoleptic properties like the 25% reduction in the production time.El presente trabajo ilustra la implementación de los principios de la calidad basada en el diseño (QbD) en la fabricación industrial de medicamentos. Como caso de estudio se eligió la elaboración de tabletas masticables, cuya formulación y proceso de manufactura se rediseñaron. Se tomó como punto de partida la definición del perfil de calidad para el producto, el que sirvió de base para identificar los atributos críticos de calidad. Posteriormente, se analizó el impacto y la criticidad de cada una de las operaciones de fabricación en la calidad del producto, y para cada una de las operaciones que resultaron críticas, se realizó el análisis de riesgos. De acuerdo con los resultados obtenidos, se diseñaron e implementaron las estrategias de mitigación, logrando una formulación acorde con las expectativas desde el punto de vista organoléptico y la reducción en un 25% de los tiempos de producción.application/pdfspaRevista Colombiana de Ciencias Químico Farmacéuticashttp://revistas.unal.edu.co/index.php/rccquifa/article/view/45116Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 190-214 0034-7418 1909-6356Rocha Saleme, Héctor and Cuadro Julio, Jorge Enrique and Mora Huertas, Claudia Elizabeth (2013) Application of quality by design (qbd) to reformulation of chewable tablets. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 190-214 0034-7418 1909-6356 .Application of quality by design (qbd) to reformulation of chewable tabletsArtículo de revistainfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1http://purl.org/coar/version/c_970fb48d4fbd8a85Texthttp://purl.org/redcol/resource_type/ARTcalidad basada en el diseñogestión del riesgodiseño estadístico experimentalformulacióntabletas masticablesQuality by Design (QbD)risk managementstatistical experimental designformulationchewable tabletsORIGINAL45116-216479-1-SM.pdfapplication/pdf263089https://repositorio.unal.edu.co/bitstream/unal/49326/1/45116-216479-1-SM.pdf7068cf4aefb716d45f8f750e811def33MD51THUMBNAIL45116-216479-1-SM.pdf.jpg45116-216479-1-SM.pdf.jpgGenerated Thumbnailimage/jpeg5700https://repositorio.unal.edu.co/bitstream/unal/49326/2/45116-216479-1-SM.pdf.jpga064ec039c3c99297a05a83df88548abMD52unal/49326oai:repositorio.unal.edu.co:unal/493262022-12-14 23:03:56.274Repositorio Institucional Universidad Nacional de Colombiarepositorio_nal@unal.edu.co
dc.title.spa.fl_str_mv Application of quality by design (qbd) to reformulation of chewable tablets
title Application of quality by design (qbd) to reformulation of chewable tablets
spellingShingle Application of quality by design (qbd) to reformulation of chewable tablets
calidad basada en el diseño
gestión del riesgo
diseño estadístico experimental
formulación
tabletas masticables
Quality by Design (QbD)
risk management
statistical experimental design
formulation
chewable tablets
title_short Application of quality by design (qbd) to reformulation of chewable tablets
title_full Application of quality by design (qbd) to reformulation of chewable tablets
title_fullStr Application of quality by design (qbd) to reformulation of chewable tablets
title_full_unstemmed Application of quality by design (qbd) to reformulation of chewable tablets
title_sort Application of quality by design (qbd) to reformulation of chewable tablets
dc.creator.fl_str_mv Rocha Saleme, Héctor
Cuadro Julio, Jorge Enrique
Mora Huertas, Claudia Elizabeth
dc.contributor.author.spa.fl_str_mv Rocha Saleme, Héctor
Cuadro Julio, Jorge Enrique
Mora Huertas, Claudia Elizabeth
dc.subject.proposal.spa.fl_str_mv calidad basada en el diseño
gestión del riesgo
diseño estadístico experimental
formulación
tabletas masticables
Quality by Design (QbD)
risk management
statistical experimental design
formulation
chewable tablets
topic calidad basada en el diseño
gestión del riesgo
diseño estadístico experimental
formulación
tabletas masticables
Quality by Design (QbD)
risk management
statistical experimental design
formulation
chewable tablets
description This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study. In this way, product formulation and preparation procedure were reformulated. The starting point was the definition of the product quality profile from which the critical quality attributes were identified. Also, the impact and the criticality of each stage of manufacture for the product were examined regarding to their influence in achieving the critical quality attributes. Risk assessment was made for critical manufacture stages and considering the results, mitigation strategies were proposed and implemented. This leads to a formulation satisfying the requirements for the organoleptic properties like the 25% reduction in the production time.
publishDate 2013
dc.date.issued.spa.fl_str_mv 2013
dc.date.accessioned.spa.fl_str_mv 2019-06-29T08:35:36Z
dc.date.available.spa.fl_str_mv 2019-06-29T08:35:36Z
dc.type.spa.fl_str_mv Artículo de revista
dc.type.coar.fl_str_mv http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.driver.spa.fl_str_mv info:eu-repo/semantics/article
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dc.type.content.spa.fl_str_mv Text
dc.type.redcol.spa.fl_str_mv http://purl.org/redcol/resource_type/ART
format http://purl.org/coar/resource_type/c_6501
status_str publishedVersion
dc.identifier.uri.none.fl_str_mv https://repositorio.unal.edu.co/handle/unal/49326
dc.identifier.eprints.spa.fl_str_mv http://bdigital.unal.edu.co/42783/
http://bdigital.unal.edu.co/42783/2/
url https://repositorio.unal.edu.co/handle/unal/49326
http://bdigital.unal.edu.co/42783/
http://bdigital.unal.edu.co/42783/2/
dc.language.iso.spa.fl_str_mv spa
language spa
dc.relation.spa.fl_str_mv http://revistas.unal.edu.co/index.php/rccquifa/article/view/45116
dc.relation.ispartof.spa.fl_str_mv Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico Farmacéuticas
Revista Colombiana de Ciencias Químico Farmacéuticas
dc.relation.ispartofseries.none.fl_str_mv Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 190-214 0034-7418 1909-6356
dc.relation.references.spa.fl_str_mv Rocha Saleme, Héctor and Cuadro Julio, Jorge Enrique and Mora Huertas, Claudia Elizabeth (2013) Application of quality by design (qbd) to reformulation of chewable tablets. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 190-214 0034-7418 1909-6356 .
dc.rights.spa.fl_str_mv Derechos reservados - Universidad Nacional de Colombia
dc.rights.coar.fl_str_mv http://purl.org/coar/access_right/c_abf2
dc.rights.license.spa.fl_str_mv Atribución-NoComercial 4.0 Internacional
dc.rights.uri.spa.fl_str_mv http://creativecommons.org/licenses/by-nc/4.0/
dc.rights.accessrights.spa.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv Atribución-NoComercial 4.0 Internacional
Derechos reservados - Universidad Nacional de Colombia
http://creativecommons.org/licenses/by-nc/4.0/
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.mimetype.spa.fl_str_mv application/pdf
dc.publisher.spa.fl_str_mv Revista Colombiana de Ciencias Químico Farmacéuticas
institution Universidad Nacional de Colombia
bitstream.url.fl_str_mv https://repositorio.unal.edu.co/bitstream/unal/49326/1/45116-216479-1-SM.pdf
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