Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process

Detalhes bibliográficos
Autor(a) principal: Carolina Rossi Gouvêa Silva
Data de Publicação: 2021
Outros Autores: Sílvia Ligório Fialho, Jamile Barbosa, Bárbara Caroline Rodrigues de Araújo, Guilherme Carneiro, Rita de Cássia de Oliveira Sebastião, Wagner da Nova Mussel, Maria Irene Yoshida, Maria Betânia de Freitas Marques
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: https://dx.doi.org/10.21577/0103-5053.20200218
http://hdl.handle.net/1843/50603
https://orcid.org/0000-0001-8068-5211
https://orcid.org/0000-0002-0367-8170
https://orcid.org/0000-0002-5158-7783
https://orcid.org/0000-0002-9768-9830
https://orcid.org/0000-0002-6795-9457
https://orcid.org/0000-0002-0561-2343
Resumo: CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
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spelling 2023-03-02T14:52:21Z2023-03-02T14:52:21Z2021-03323638651https://dx.doi.org/10.21577/0103-5053.202002181678-4790http://hdl.handle.net/1843/50603https://orcid.org/0000-0001-8068-5211https://orcid.org/0000-0002-0367-8170https://orcid.org/0000-0002-5158-7783https://orcid.org/0000-0002-9768-9830https://orcid.org/0000-0002-6795-9457https://orcid.org/0000-0002-0561-2343CNPq - Conselho Nacional de Desenvolvimento Científico e TecnológicoFAPEMIG - Fundação de Amparo à Pesquisa do Estado de Minas GeraisCAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível SuperiorAzathioprine is an immunosuppressive drug for several inflammatory disorders. Due to its clinical relevance, to explore the solid-state properties for excipient compatibility in the product quality review process is essential. Fourier transform infrared spectroscopy, powder X-ray diffraction and thermal analysis (thermogravimetry/derivative thermogravimetry (TG/DTG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC)) were applied. The compatibility studies evidenced that starch pregelatinized, colloidal silicon dioxide, and talc are fully compatible with azathioprine. However, stearic acid, magnesium stearate, and mannitol are incompatible after heat supply at temperatures easily reached by industrial processing. The nonlinear Vyazovkin isoconversional treatment performed the kinetic study of the thermal degradation. The activation energies were determined to clarify the influence of each excipient on the thermal drug stability, an essential procedure in the pharmaceutical development, and all over the commercial live span, in Good Manufacturing Practices.engUniversidade Federal de Minas GeraisUFMGBrasilICX - DEPARTAMENTO DE QUÍMICAQuímica farmacêuticaCinética químicaFourier, Espectroscopia de infravermelho por transformada deRaios X - DifraçãoAnálise térmicaTermogravimetriaCalorimetriaTecnologia farmacêutica - Controle de qualidadeMedicamentos - AnáliseExcipientesImmunosuppressive drugGood manufacturing practicesSolid-state propertiesActivation energyVyazovkin methodFukui functionCompatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review processinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://jbcs.sbq.org.br/default.asp?ed=309Carolina Rossi Gouvêa SilvaSílvia Ligório FialhoJamile BarbosaBárbara Caroline Rodrigues de AraújoGuilherme CarneiroRita de Cássia de Oliveira SebastiãoWagner da Nova MusselMaria Irene YoshidaMaria Betânia de Freitas Marquesapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGORIGINALCompatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process.pdfCompatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process.pdfapplication/pdf7207159https://repositorio.ufmg.br/bitstream/1843/50603/2/Compatibility%20by%20a%20nonisothermal%20kinetic%20study%20of%20azathioprine%20associated%20with%20usual%20excipients%20in%20the%20product%20quality%20review%20process.pdfe9992a04a8987e49b6c62f450fe2ef49MD52LICENSELicense.txtLicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
title Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
spellingShingle Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
Carolina Rossi Gouvêa Silva
Immunosuppressive drug
Good manufacturing practices
Solid-state properties
Activation energy
Vyazovkin method
Fukui function
Química farmacêutica
Cinética química
Fourier, Espectroscopia de infravermelho por transformada de
Raios X - Difração
Análise térmica
Termogravimetria
Calorimetria
Tecnologia farmacêutica - Controle de qualidade
Medicamentos - Análise
Excipientes
title_short Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
title_full Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
title_fullStr Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
title_full_unstemmed Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
title_sort Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process
author Carolina Rossi Gouvêa Silva
author_facet Carolina Rossi Gouvêa Silva
Sílvia Ligório Fialho
Jamile Barbosa
Bárbara Caroline Rodrigues de Araújo
Guilherme Carneiro
Rita de Cássia de Oliveira Sebastião
Wagner da Nova Mussel
Maria Irene Yoshida
Maria Betânia de Freitas Marques
author_role author
author2 Sílvia Ligório Fialho
Jamile Barbosa
Bárbara Caroline Rodrigues de Araújo
Guilherme Carneiro
Rita de Cássia de Oliveira Sebastião
Wagner da Nova Mussel
Maria Irene Yoshida
Maria Betânia de Freitas Marques
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Carolina Rossi Gouvêa Silva
Sílvia Ligório Fialho
Jamile Barbosa
Bárbara Caroline Rodrigues de Araújo
Guilherme Carneiro
Rita de Cássia de Oliveira Sebastião
Wagner da Nova Mussel
Maria Irene Yoshida
Maria Betânia de Freitas Marques
dc.subject.por.fl_str_mv Immunosuppressive drug
Good manufacturing practices
Solid-state properties
Activation energy
Vyazovkin method
Fukui function
topic Immunosuppressive drug
Good manufacturing practices
Solid-state properties
Activation energy
Vyazovkin method
Fukui function
Química farmacêutica
Cinética química
Fourier, Espectroscopia de infravermelho por transformada de
Raios X - Difração
Análise térmica
Termogravimetria
Calorimetria
Tecnologia farmacêutica - Controle de qualidade
Medicamentos - Análise
Excipientes
dc.subject.other.pt_BR.fl_str_mv Química farmacêutica
Cinética química
Fourier, Espectroscopia de infravermelho por transformada de
Raios X - Difração
Análise térmica
Termogravimetria
Calorimetria
Tecnologia farmacêutica - Controle de qualidade
Medicamentos - Análise
Excipientes
description CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
publishDate 2021
dc.date.issued.fl_str_mv 2021-03
dc.date.accessioned.fl_str_mv 2023-03-02T14:52:21Z
dc.date.available.fl_str_mv 2023-03-02T14:52:21Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/50603
dc.identifier.doi.pt_BR.fl_str_mv https://dx.doi.org/10.21577/0103-5053.20200218
dc.identifier.issn.pt_BR.fl_str_mv 1678-4790
dc.identifier.orcid.pt_BR.fl_str_mv https://orcid.org/0000-0001-8068-5211
https://orcid.org/0000-0002-0367-8170
https://orcid.org/0000-0002-5158-7783
https://orcid.org/0000-0002-9768-9830
https://orcid.org/0000-0002-6795-9457
https://orcid.org/0000-0002-0561-2343
url https://dx.doi.org/10.21577/0103-5053.20200218
http://hdl.handle.net/1843/50603
https://orcid.org/0000-0001-8068-5211
https://orcid.org/0000-0002-0367-8170
https://orcid.org/0000-0002-5158-7783
https://orcid.org/0000-0002-9768-9830
https://orcid.org/0000-0002-6795-9457
https://orcid.org/0000-0002-0561-2343
identifier_str_mv 1678-4790
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.publisher.initials.fl_str_mv UFMG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv ICX - DEPARTAMENTO DE QUÍMICA
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
instname:Universidade Federal de Minas Gerais (UFMG)
instacron:UFMG
instname_str Universidade Federal de Minas Gerais (UFMG)
instacron_str UFMG
institution UFMG
reponame_str Repositório Institucional da UFMG
collection Repositório Institucional da UFMG
bitstream.url.fl_str_mv https://repositorio.ufmg.br/bitstream/1843/50603/2/Compatibility%20by%20a%20nonisothermal%20kinetic%20study%20of%20azathioprine%20associated%20with%20usual%20excipients%20in%20the%20product%20quality%20review%20process.pdf
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