Please use this identifier to cite or link to this item:
https://hdl.handle.net/10316/106536
DC Field | Value | Language |
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dc.contributor.author | Simões, Ana | - |
dc.contributor.author | Miranda, Margarida | - |
dc.contributor.author | Cardoso, Catarina | - |
dc.contributor.author | Veiga, Francisco | - |
dc.contributor.author | Vitorino, Carla | - |
dc.date.accessioned | 2023-04-06T11:43:42Z | - |
dc.date.available | 2023-04-06T11:43:42Z | - |
dc.date.issued | 2020-08-28 | - |
dc.identifier.issn | 1999-4923 | pt |
dc.identifier.uri | https://hdl.handle.net/10316/106536 | - |
dc.description.abstract | 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. | pt |
dc.language.iso | eng | pt |
dc.publisher | MDPI | pt |
dc.relation | research grant PD/BDE/135074/2017 assigned by FCT (Fundação para a Ciência e a Tecnologia) and Dendropharma, Investigação e Serviços de Intervenção Farmacêutica, Sociedade Unipessoal Lda, from Drugs R&D Doctoral Program | pt |
dc.relation | PD/BDE/135075/2017 assigned by FCT and Laboratórios Basi from Drugs R&D Doctoral Program. | pt |
dc.relation | UIDB/50006/2020 | pt |
dc.relation | UID/QUI/00313/2020 | pt |
dc.rights | openAccess | pt |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | pt |
dc.subject | rheology | pt |
dc.subject | method validation | pt |
dc.subject | equipment qualification | pt |
dc.subject | topical dosage forms | pt |
dc.subject | regulatory requirements | pt |
dc.title | Rheology by Design: A Regulatory Tutorial for Analytical Method Validation | pt |
dc.type | article | - |
degois.publication.firstPage | 820 | pt |
degois.publication.issue | 9 | pt |
degois.publication.title | Pharmaceutics | pt |
dc.peerreviewed | yes | pt |
dc.identifier.doi | 10.3390/pharmaceutics12090820 | pt |
degois.publication.volume | 12 | pt |
dc.date.embargo | 2020-08-28 | * |
uc.date.periodoEmbargo | 0 | pt |
item.fulltext | Com Texto completo | - |
item.grantfulltext | open | - |
item.languageiso639-1 | en | - |
item.cerifentitytype | Publications | - |
item.openairetype | article | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
crisitem.project.grantno | Associated Laboratory for Green Chemistry - Clean Technologies and Processes- REQUIMTE | - |
crisitem.author.researchunit | CQC - Coimbra Chemistry Centre | - |
crisitem.author.parentresearchunit | Faculty of Sciences and Technology | - |
crisitem.author.orcid | 0000-0002-1041-0068 | - |
crisitem.author.orcid | 0000-0003-3424-548X | - |
Appears in Collections: | FFUC- Artigos em Revistas Internacionais I&D CQC - Artigos em Revistas Internacionais I&D CNC - Artigos em Revistas Internacionais |
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File | Description | Size | Format | |
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Rheology-by-design-A-regulatory-tutorial-for-analytical-method-validationPharmaceutics.pdf | 5.05 MB | Adobe PDF | View/Open |
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This item is licensed under a Creative Commons License