Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation

The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retro...

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Autores: Galí Serra, Albert, Ascaso Anglés, Magda, Nardi Ricart, Anna, Suñé Pou, Marc, Pérez Lozano, Pilar, Suñé i Negre, Josep M. (Josep Maria), García Montoya, Encarna
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/173526
Acceso en línea:https://hdl.handle.net/2445/173526
Access Level:acceso abierto
Palabra clave:Síntesi de fàrmacs
Drug synthesis
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spelling Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and ValidationGalí Serra, AlbertAscaso Anglés, MagdaNardi Ricart, AnnaSuñé Pou, MarcPérez Lozano, PilarSuñé i Negre, Josep M. (Josep Maria)García Montoya, EncarnaSíntesi de fàrmacsDrug synthesisThe objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retrospective statistical analysis, the recommended working ranges are identified. Retrospective analysis showed that the design of experiments (DoE) provided an improved process variable configuration. Therefore, it is decided to study two critical parameters: Product temperature and drum speed, with an additional 22 experimental design. The quality results of the samples analyzed show that the aesthetic defects of the batches made with the new working ranges have been reduced. These results have also been corroborated with the 42 industrial batches manufactured with the new ranges. With the optimized parameters, tablets have been coated and the suitability of the model determined. The results demonstrated the overall reliability and effectiveness of the proposed Quality by Design approach and provides a useful tool to help optimize the industrial coating process. This study confirms that it is possible to optimize and validate the manufacturing process of an existing commercial product by means of a DoE with retrospective data. Therefore, no variation in the dossier is required.MDPI2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/173526Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.3390/pharmaceutics12080743Pharmaceutics, 2020, vol. 12, num. 8https://doi.org/10.3390/pharmaceutics12080743cc-by (c) Galí Serra, Albert et al., 2020http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1735262026-05-27T06:46:51Z
dc.title.none.fl_str_mv Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
title Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
spellingShingle Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
Galí Serra, Albert
Síntesi de fàrmacs
Drug synthesis
title_short Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
title_full Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
title_fullStr Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
title_full_unstemmed Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
title_sort Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation
dc.creator.none.fl_str_mv Galí Serra, Albert
Ascaso Anglés, Magda
Nardi Ricart, Anna
Suñé Pou, Marc
Pérez Lozano, Pilar
Suñé i Negre, Josep M. (Josep Maria)
García Montoya, Encarna
author Galí Serra, Albert
author_facet Galí Serra, Albert
Ascaso Anglés, Magda
Nardi Ricart, Anna
Suñé Pou, Marc
Pérez Lozano, Pilar
Suñé i Negre, Josep M. (Josep Maria)
García Montoya, Encarna
author_role author
author2 Ascaso Anglés, Magda
Nardi Ricart, Anna
Suñé Pou, Marc
Pérez Lozano, Pilar
Suñé i Negre, Josep M. (Josep Maria)
García Montoya, Encarna
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv Síntesi de fàrmacs
Drug synthesis
topic Síntesi de fàrmacs
Drug synthesis
description The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retrospective statistical analysis, the recommended working ranges are identified. Retrospective analysis showed that the design of experiments (DoE) provided an improved process variable configuration. Therefore, it is decided to study two critical parameters: Product temperature and drum speed, with an additional 22 experimental design. The quality results of the samples analyzed show that the aesthetic defects of the batches made with the new working ranges have been reduced. These results have also been corroborated with the 42 industrial batches manufactured with the new ranges. With the optimized parameters, tablets have been coated and the suitability of the model determined. The results demonstrated the overall reliability and effectiveness of the proposed Quality by Design approach and provides a useful tool to help optimize the industrial coating process. This study confirms that it is possible to optimize and validate the manufacturing process of an existing commercial product by means of a DoE with retrospective data. Therefore, no variation in the dossier is required.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/173526
url https://hdl.handle.net/2445/173526
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.3390/pharmaceutics12080743
Pharmaceutics, 2020, vol. 12, num. 8
https://doi.org/10.3390/pharmaceutics12080743
dc.rights.none.fl_str_mv cc-by (c) Galí Serra, Albert et al., 2020
http://creativecommons.org/licenses/by/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Galí Serra, Albert et al., 2020
http://creativecommons.org/licenses/by/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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