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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/124369
Ver los metadatos del registro completo
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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 Técnicas2025-09-29T09:55:38Zoai: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:34982025-09-29 09:55:38.816CONICET 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 |
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reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
reponame_str |
CONICET Digital (CONICET) |
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CONICET Digital (CONICET) |
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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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1844613676662784000 |
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13.070432 |