Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials

Autores
Testa, Carla G.; Prado, Livia D.; Costa, Rogéria N.; Costa, Michelle L.; Garro Linck, Yamila; Monti, Gustavo Alberto; Cuffini, Silvia Lucia; Rocha, Helvécio V. A.
Año de publicación
2019
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Olanzapine (OLZ), a drug for the treatment of schizophrenia, presents in more than 60 crystal forms. Polymorphs I, II and III were reported, however, the preparation conditions for pure II and III have not been reported. Polymorph IV was reported but this form is actually polymorph II described at different temperature. The diversity of solid forms of OLZ, the change in the nomenclature found in the literature and the presence of polymorphic mixture in samples, increase the difficulty for a correct solid state characterization. Therefore, the goal was the polymorphic identification of three OLZ raw materials, highlighting the limitation of conventional techniques (typically used in analytical control) and the necessity to use a combination of advanced ones to solve this challenge. The samples were studied by conventional techniques such as powder X-ray diffraction, thermoanalytical techniques, infrared spectroscopy. In apart from that, synchrotron powder X-ray diffraction (SPXRD) and solid state nuclear magnetic resonance (ss-NMR) were used. All samples were in accordance with the pharmacopoeia criteria. However, the conventional techniques were not specific for the complete polymorphic identification. Therefore, a combination of advanced techniques (SPXRD and ss-NMR) was necessary to identify the mixture of polymorphs (I, II and III) in all samples.
Fil: Testa, Carla G.. Laboratório Farmacêutico da Marinha; Brasil. Mestrado Profissional em Gestão, Pesquisa e Desenvolvimento na Indústria Farmacêutica; Brasil
Fil: Prado, Livia D.. Universidade Federal Fluminense; Brasil. Fundación Oswaldo Cruz; Brasil
Fil: Costa, Rogéria N.. Universidade Federal de Sao Paulo; Brasil
Fil: Costa, Michelle L.. Universidade Estadual Paulista Julio de Mesquita Filho; Brasil
Fil: Garro Linck, Yamila. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; Argentina
Fil: Monti, Gustavo Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; Argentina
Fil: Cuffini, Silvia Lucia. Universidade Federal de Sao Paulo; Brasil
Fil: Rocha, Helvécio V. A.. Fundación Oswaldo Cruz; Brasil
Materia
OLANZAPINE
POLYMORPHISM
SOLID STATE NUCLEAR MAGNETIC RESONANCE
THERMAL ANALYSIS
X-RAY DIFFRACTION
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/124369
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/124369
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materialsTesta, Carla G.Prado, Livia D.Costa, Rogéria N.Costa, Michelle L.Garro Linck, YamilaMonti, Gustavo AlbertoCuffini, Silvia LuciaRocha, Helvécio V. A.OLANZAPINEPOLYMORPHISMSOLID STATE NUCLEAR MAGNETIC RESONANCETHERMAL ANALYSISX-RAY DIFFRACTIONhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Olanzapine (OLZ), a drug for the treatment of schizophrenia, presents in more than 60 crystal forms. Polymorphs I, II and III were reported, however, the preparation conditions for pure II and III have not been reported. Polymorph IV was reported but this form is actually polymorph II described at different temperature. The diversity of solid forms of OLZ, the change in the nomenclature found in the literature and the presence of polymorphic mixture in samples, increase the difficulty for a correct solid state characterization. Therefore, the goal was the polymorphic identification of three OLZ raw materials, highlighting the limitation of conventional techniques (typically used in analytical control) and the necessity to use a combination of advanced ones to solve this challenge. The samples were studied by conventional techniques such as powder X-ray diffraction, thermoanalytical techniques, infrared spectroscopy. In apart from that, synchrotron powder X-ray diffraction (SPXRD) and solid state nuclear magnetic resonance (ss-NMR) were used. All samples were in accordance with the pharmacopoeia criteria. However, the conventional techniques were not specific for the complete polymorphic identification. Therefore, a combination of advanced techniques (SPXRD and ss-NMR) was necessary to identify the mixture of polymorphs (I, II and III) in all samples.Fil: Testa, Carla G.. Laboratório Farmacêutico da Marinha; Brasil. Mestrado Profissional em Gestão, Pesquisa e Desenvolvimento na Indústria Farmacêutica; BrasilFil: Prado, Livia D.. Universidade Federal Fluminense; Brasil. Fundación Oswaldo Cruz; BrasilFil: Costa, Rogéria N.. Universidade Federal de Sao Paulo; BrasilFil: Costa, Michelle L.. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Garro Linck, Yamila. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; ArgentinaFil: Monti, Gustavo Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; ArgentinaFil: Cuffini, Silvia Lucia. Universidade Federal de Sao Paulo; BrasilFil: Rocha, Helvécio V. A.. Fundación Oswaldo Cruz; BrasilElsevier Science2019-02-10info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/124369Testa, Carla G.; Prado, Livia D.; Costa, Rogéria N.; Costa, Michelle L.; Garro Linck, Yamila; et al.; Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials; Elsevier Science; International Journal Of Pharmaceutics; 556; 10-2-2019; 125-1350378-5173CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/abs/pii/S037851731830913Xinfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.ijpharm.2018.12.008info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T14:50:37Zoai:ri.conicet.gov.ar:11336/124369instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 14:50:37.274CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
title Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
spellingShingle Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
Testa, Carla G.
OLANZAPINE
POLYMORPHISM
SOLID STATE NUCLEAR MAGNETIC RESONANCE
THERMAL ANALYSIS
X-RAY DIFFRACTION
title_short Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
title_full Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
title_fullStr Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
title_full_unstemmed Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
title_sort Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
dc.creator.none.fl_str_mv Testa, Carla G.
Prado, Livia D.
Costa, Rogéria N.
Costa, Michelle L.
Garro Linck, Yamila
Monti, Gustavo Alberto
Cuffini, Silvia Lucia
Rocha, Helvécio V. A.
author Testa, Carla G.
author_facet Testa, Carla G.
Prado, Livia D.
Costa, Rogéria N.
Costa, Michelle L.
Garro Linck, Yamila
Monti, Gustavo Alberto
Cuffini, Silvia Lucia
Rocha, Helvécio V. A.
author_role author
author2 Prado, Livia D.
Costa, Rogéria N.
Costa, Michelle L.
Garro Linck, Yamila
Monti, Gustavo Alberto
Cuffini, Silvia Lucia
Rocha, Helvécio V. A.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv OLANZAPINE
POLYMORPHISM
SOLID STATE NUCLEAR MAGNETIC RESONANCE
THERMAL ANALYSIS
X-RAY DIFFRACTION
topic OLANZAPINE
POLYMORPHISM
SOLID STATE NUCLEAR MAGNETIC RESONANCE
THERMAL ANALYSIS
X-RAY DIFFRACTION
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Olanzapine (OLZ), a drug for the treatment of schizophrenia, presents in more than 60 crystal forms. Polymorphs I, II and III were reported, however, the preparation conditions for pure II and III have not been reported. Polymorph IV was reported but this form is actually polymorph II described at different temperature. The diversity of solid forms of OLZ, the change in the nomenclature found in the literature and the presence of polymorphic mixture in samples, increase the difficulty for a correct solid state characterization. Therefore, the goal was the polymorphic identification of three OLZ raw materials, highlighting the limitation of conventional techniques (typically used in analytical control) and the necessity to use a combination of advanced ones to solve this challenge. The samples were studied by conventional techniques such as powder X-ray diffraction, thermoanalytical techniques, infrared spectroscopy. In apart from that, synchrotron powder X-ray diffraction (SPXRD) and solid state nuclear magnetic resonance (ss-NMR) were used. All samples were in accordance with the pharmacopoeia criteria. However, the conventional techniques were not specific for the complete polymorphic identification. Therefore, a combination of advanced techniques (SPXRD and ss-NMR) was necessary to identify the mixture of polymorphs (I, II and III) in all samples.
Fil: Testa, Carla G.. Laboratório Farmacêutico da Marinha; Brasil. Mestrado Profissional em Gestão, Pesquisa e Desenvolvimento na Indústria Farmacêutica; Brasil
Fil: Prado, Livia D.. Universidade Federal Fluminense; Brasil. Fundación Oswaldo Cruz; Brasil
Fil: Costa, Rogéria N.. Universidade Federal de Sao Paulo; Brasil
Fil: Costa, Michelle L.. Universidade Estadual Paulista Julio de Mesquita Filho; Brasil
Fil: Garro Linck, Yamila. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; Argentina
Fil: Monti, Gustavo Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Física Enrique Gaviola. Universidad Nacional de Córdoba. Instituto de Física Enrique Gaviola; Argentina. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía y Física; Argentina
Fil: Cuffini, Silvia Lucia. Universidade Federal de Sao Paulo; Brasil
Fil: Rocha, Helvécio V. A.. Fundación Oswaldo Cruz; Brasil
description Olanzapine (OLZ), a drug for the treatment of schizophrenia, presents in more than 60 crystal forms. Polymorphs I, II and III were reported, however, the preparation conditions for pure II and III have not been reported. Polymorph IV was reported but this form is actually polymorph II described at different temperature. The diversity of solid forms of OLZ, the change in the nomenclature found in the literature and the presence of polymorphic mixture in samples, increase the difficulty for a correct solid state characterization. Therefore, the goal was the polymorphic identification of three OLZ raw materials, highlighting the limitation of conventional techniques (typically used in analytical control) and the necessity to use a combination of advanced ones to solve this challenge. The samples were studied by conventional techniques such as powder X-ray diffraction, thermoanalytical techniques, infrared spectroscopy. In apart from that, synchrotron powder X-ray diffraction (SPXRD) and solid state nuclear magnetic resonance (ss-NMR) were used. All samples were in accordance with the pharmacopoeia criteria. However, the conventional techniques were not specific for the complete polymorphic identification. Therefore, a combination of advanced techniques (SPXRD and ss-NMR) was necessary to identify the mixture of polymorphs (I, II and III) in all samples.
publishDate 2019
dc.date.none.fl_str_mv 2019-02-10
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/124369
Testa, Carla G.; Prado, Livia D.; Costa, Rogéria N.; Costa, Michelle L.; Garro Linck, Yamila; et al.; Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials; Elsevier Science; International Journal Of Pharmaceutics; 556; 10-2-2019; 125-135
0378-5173
CONICET Digital
CONICET
url http://hdl.handle.net/11336/124369
identifier_str_mv Testa, Carla G.; Prado, Livia D.; Costa, Rogéria N.; Costa, Michelle L.; Garro Linck, Yamila; et al.; Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials; Elsevier Science; International Journal Of Pharmaceutics; 556; 10-2-2019; 125-135
0378-5173
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/abs/pii/S037851731830913X
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ijpharm.2018.12.008
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier Science
publisher.none.fl_str_mv Elsevier Science
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.22299

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