Rheology by Design: A Regulatory Tutorial for Analytical Method Validation

Detalhes bibliográficos
Autor(a) principal: Simões, Ana
Data de Publicação: 2020
Outros Autores: Miranda, Margarida, Cardoso, Catarina, Veiga, Francisco, Vitorino, Carla
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10316/106536
https://doi.org/10.3390/pharmaceutics12090820
Resumo: The increasing demand for product and process understanding as an active pursuit in the quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of topical products, has unveiled the tremendous potential of rheology methods as a tool for microstructure characterization of topical semisolid dosage forms. Accordingly, procedure standardization is a dire need. This work aimed at developing and validating a methodology tutorial for rheology analysis. A 1% hydrocortisone cream was used as model cream formulation. Through a risk assessment analysis, the impact of selected critical method variables (geometry, temperature and application mode) was estimated in a broad range of rheological critical analytical attributes-zero-shear viscosity, upper-shear thinning viscosity, lower-shear thinning viscosity, infinite-shear viscosity, rotational yield point, thixotropic relative area, linear viscoelastic region, oscillatory yield point, storage modulus, loss modulus, and loss tangent. The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition. The thixotropic relative area, oscillatory yield point, flow point and viscosity related endpoints proved to be highly sensitive and discriminatory parameters. This rationale provided a standard framework for the development of a reliable and robust rheology profile acquisition.
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spelling Rheology by Design: A Regulatory Tutorial for Analytical Method Validationrheologymethod validationequipment qualificationtopical dosage formsregulatory requirementsThe increasing demand for product and process understanding as an active pursuit in the quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of topical products, has unveiled the tremendous potential of rheology methods as a tool for microstructure characterization of topical semisolid dosage forms. Accordingly, procedure standardization is a dire need. This work aimed at developing and validating a methodology tutorial for rheology analysis. A 1% hydrocortisone cream was used as model cream formulation. Through a risk assessment analysis, the impact of selected critical method variables (geometry, temperature and application mode) was estimated in a broad range of rheological critical analytical attributes-zero-shear viscosity, upper-shear thinning viscosity, lower-shear thinning viscosity, infinite-shear viscosity, rotational yield point, thixotropic relative area, linear viscoelastic region, oscillatory yield point, storage modulus, loss modulus, and loss tangent. The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition. The thixotropic relative area, oscillatory yield point, flow point and viscosity related endpoints proved to be highly sensitive and discriminatory parameters. This rationale provided a standard framework for the development of a reliable and robust rheology profile acquisition.MDPI2020-08-28info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10316/106536http://hdl.handle.net/10316/106536https://doi.org/10.3390/pharmaceutics12090820eng1999-4923Simões, AnaMiranda, MargaridaCardoso, CatarinaVeiga, FranciscoVitorino, Carlainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-04-10T20:43:17Zoai:estudogeral.uc.pt:10316/106536Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:22:58.828692Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
title Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
spellingShingle Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
Simões, Ana
rheology
method validation
equipment qualification
topical dosage forms
regulatory requirements
title_short Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
title_full Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
title_fullStr Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
title_full_unstemmed Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
title_sort Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
author Simões, Ana
author_facet Simões, Ana
Miranda, Margarida
Cardoso, Catarina
Veiga, Francisco
Vitorino, Carla
author_role author
author2 Miranda, Margarida
Cardoso, Catarina
Veiga, Francisco
Vitorino, Carla
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Simões, Ana
Miranda, Margarida
Cardoso, Catarina
Veiga, Francisco
Vitorino, Carla
dc.subject.por.fl_str_mv rheology
method validation
equipment qualification
topical dosage forms
regulatory requirements
topic rheology
method validation
equipment qualification
topical dosage forms
regulatory requirements
description The increasing demand for product and process understanding as an active pursuit in the quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of topical products, has unveiled the tremendous potential of rheology methods as a tool for microstructure characterization of topical semisolid dosage forms. Accordingly, procedure standardization is a dire need. This work aimed at developing and validating a methodology tutorial for rheology analysis. A 1% hydrocortisone cream was used as model cream formulation. Through a risk assessment analysis, the impact of selected critical method variables (geometry, temperature and application mode) was estimated in a broad range of rheological critical analytical attributes-zero-shear viscosity, upper-shear thinning viscosity, lower-shear thinning viscosity, infinite-shear viscosity, rotational yield point, thixotropic relative area, linear viscoelastic region, oscillatory yield point, storage modulus, loss modulus, and loss tangent. The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition. The thixotropic relative area, oscillatory yield point, flow point and viscosity related endpoints proved to be highly sensitive and discriminatory parameters. This rationale provided a standard framework for the development of a reliable and robust rheology profile acquisition.
publishDate 2020
dc.date.none.fl_str_mv 2020-08-28
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10316/106536
http://hdl.handle.net/10316/106536
https://doi.org/10.3390/pharmaceutics12090820
url http://hdl.handle.net/10316/106536
https://doi.org/10.3390/pharmaceutics12090820
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1999-4923
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instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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