SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening

During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product's manufacturability, critical quality a...

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Autores: Suñé i Negre, Josep M. (Josep Maria), Figuera-Figuera, Alba, Suñé Pou, Marc, Pérez Lozano, Pilar, García Montoya, Encarna, Amela Navarro, Joaquím
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/208060
Acesso em linha:https://hdl.handle.net/2445/208060
Access Level:acceso abierto
Palavra-chave:Tecnologia farmacèutica
Desenvolupament de medicaments
Comprimits (Medicina)
Pharmaceutical technology
Drug development
Tablets (Medicine)
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spelling SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier ScreeningSuñé i Negre, Josep M. (Josep Maria)Figuera-Figuera, AlbaSuñé Pou, MarcPérez Lozano, PilarGarcía Montoya, EncarnaAmela Navarro, JoaquímTecnologia farmacèuticaDesenvolupament de medicamentsComprimits (Medicina)Pharmaceutical technologyDrug developmentTablets (Medicine)During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product's manufacturability, critical quality attributes, and bioavailability. The objective of this study was to validate the manufacturing process of the drug Linezolid from three different sources at both the pilot and industrial scale and to identify differences in critical material attributes between the API manufacturers. Furthermore, the scalability factor between the pilot and industrial scale and the suitability of a process for direct compression were also evaluated. In the present study, the different sources of API were characterized by SeDeM methodology, particle size distribution, and scanning electron microscopy determinations. The statistical analysis revealed that no statistically significant differences were found for any of the parameters under study for the same API source analyzed on both scales. On the other hand, for most of the parameters evaluated, statistical differences were observed between the different sources. It was concluded that SeDeM was able to successfully validate the API manufacturing process, assess scalability, and distinguish between sources. Therefore, it could be highly valuable in the formulation phase to select the best API source. Keywords: Linezolid; SeDeM expert system; critical material attribute; critical quality attribute; direct compression; drug substance manufacturers; particle size; powder characterization; preformulation; process validation.MDPI2024202420232024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion25 p.application/pdfhttps://hdl.handle.net/2445/208060Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.3390/pharmaceutics15082034Pharmaceutics, 2023, vol. 15, p. 1-25https://doi.org/10.3390/pharmaceutics15082034cc-by (c) Figuera-Figuera, A. et al., 2023http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2080602026-05-29T05:05:01Z
dc.title.none.fl_str_mv SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
title SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
spellingShingle SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
Suñé i Negre, Josep M. (Josep Maria)
Tecnologia farmacèutica
Desenvolupament de medicaments
Comprimits (Medicina)
Pharmaceutical technology
Drug development
Tablets (Medicine)
title_short SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
title_full SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
title_fullStr SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
title_full_unstemmed SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
title_sort SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening
dc.creator.none.fl_str_mv Suñé i Negre, Josep M. (Josep Maria)
Figuera-Figuera, Alba
Suñé Pou, Marc
Pérez Lozano, Pilar
García Montoya, Encarna
Amela Navarro, Joaquím
author Suñé i Negre, Josep M. (Josep Maria)
author_facet Suñé i Negre, Josep M. (Josep Maria)
Figuera-Figuera, Alba
Suñé Pou, Marc
Pérez Lozano, Pilar
García Montoya, Encarna
Amela Navarro, Joaquím
author_role author
author2 Figuera-Figuera, Alba
Suñé Pou, Marc
Pérez Lozano, Pilar
García Montoya, Encarna
Amela Navarro, Joaquím
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv Tecnologia farmacèutica
Desenvolupament de medicaments
Comprimits (Medicina)
Pharmaceutical technology
Drug development
Tablets (Medicine)
topic Tecnologia farmacèutica
Desenvolupament de medicaments
Comprimits (Medicina)
Pharmaceutical technology
Drug development
Tablets (Medicine)
description During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product's manufacturability, critical quality attributes, and bioavailability. The objective of this study was to validate the manufacturing process of the drug Linezolid from three different sources at both the pilot and industrial scale and to identify differences in critical material attributes between the API manufacturers. Furthermore, the scalability factor between the pilot and industrial scale and the suitability of a process for direct compression were also evaluated. In the present study, the different sources of API were characterized by SeDeM methodology, particle size distribution, and scanning electron microscopy determinations. The statistical analysis revealed that no statistically significant differences were found for any of the parameters under study for the same API source analyzed on both scales. On the other hand, for most of the parameters evaluated, statistical differences were observed between the different sources. It was concluded that SeDeM was able to successfully validate the API manufacturing process, assess scalability, and distinguish between sources. Therefore, it could be highly valuable in the formulation phase to select the best API source. Keywords: Linezolid; SeDeM expert system; critical material attribute; critical quality attribute; direct compression; drug substance manufacturers; particle size; powder characterization; preformulation; process validation.
publishDate 2023
dc.date.none.fl_str_mv 2023
2024
2024
2024
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/2445/208060
url https://hdl.handle.net/2445/208060
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/pharmaceutics15082034
Pharmaceutics, 2023, vol. 15, p. 1-25
https://doi.org/10.3390/pharmaceutics15082034
dc.rights.none.fl_str_mv cc-by (c) Figuera-Figuera, A. et al., 2023
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Figuera-Figuera, A. et al., 2023
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 25 p.
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:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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