Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materials
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.ijpharm.2018.12.008 http://hdl.handle.net/11449/185322 |
Resumo: | 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. |
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Challenging identification of polymorphic mixture: Polymorphs I, II and III in olanzapine raw materialsOlanzapinePolymorphismX-ray diffractionThermal analysisSolid state nuclear magnetic resonanceOlanzapine (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.CONICET ArgentinaANPCYT ArgentinaConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Lab Farmaceut Marinha, Av Dom Helder Camara 315, BR-20911291 Rio De Janeiro, BrazilFarmanguinhos Fiocruz, Mestrado Profiss Gestao Pesquisa & Desenvolvirnen, Av Cmte Guaranys 447, BR-22775903 Rio De Janeiro, BrazilUniv Fed Fluminense, Programa Posgrad Quim, Outeiro Sao Joao Batista S-N, BR-24210130 Niteroi, RJ, BrazilFarmanguinhos Fiocruz, Lab Micro & Nanotecnol, Av Brasil 4036, BR-21040361 Rio De Janeiro, BrazilUniv Fed Sao Paulo, Programa Posgrad Engn & Ciencia Mat, Rua Talim 330, BR-12231280 Sao Jose Dos Campos, BrazilUniv Estadual Paulista, Dept Mat & Tecnol, Av Dr Ariberto Pereira Cunha 333, BR-12516410 Guaratingueta, BrazilUniv Nacl Cordoba, Fac Matemat Astron Fis & Computat, Ciudad Univ,X5000HUA, Cordoba, ArgentinaConsejo Nacl Invest Cient & Tecn, Inst Fis Enrique Gaviola, Ciudad Univ,X5016LAE, Cordoba, ArgentinaUniv Estadual Paulista, Dept Mat & Tecnol, Av Dr Ariberto Pereira Cunha 333, BR-12516410 Guaratingueta, BrazilCONICET Argentina: 11220130100746COANPCYT Argentina: PICT 1095/2014CNPq: 305492/2017-9Elsevier B.V.Lab Farmaceut MarinhaFarmanguinhos FiocruzUniversidade Federal Fluminense (UFF)Universidade Federal de São Paulo (UNIFESP)Universidade Estadual Paulista (Unesp)Univ Nacl CordobaConsejo Nacl Invest Cient & TecnTesta, Carla G.Prado, Livia D.Costa, Rogeria N.Costa, Michelle L. [UNESP]Linck, Yamila G.Monti, Gustavo A.Cuffini, Silvia L.Rocha, Helvecio V. A.2019-10-04T12:34:27Z2019-10-04T12:34:27Z2019-02-10info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article125-135http://dx.doi.org/10.1016/j.ijpharm.2018.12.008International Journal Of Pharmaceutics. Amsterdam: Elsevier Science Bv, v. 556, p. 125-135, 2019.0378-5173http://hdl.handle.net/11449/18532210.1016/j.ijpharm.2018.12.008WOS:000455968700013Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengInternational Journal Of Pharmaceuticsinfo:eu-repo/semantics/openAccess2024-07-02T15:03:45Zoai:repositorio.unesp.br:11449/185322Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T17:00:24.368911Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
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 X-ray diffraction Thermal analysis Solid state nuclear magnetic resonance |
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 |
author |
Testa, Carla G. |
author_facet |
Testa, Carla G. Prado, Livia D. Costa, Rogeria N. Costa, Michelle L. [UNESP] Linck, Yamila G. Monti, Gustavo A. Cuffini, Silvia L. Rocha, Helvecio V. A. |
author_role |
author |
author2 |
Prado, Livia D. Costa, Rogeria N. Costa, Michelle L. [UNESP] Linck, Yamila G. Monti, Gustavo A. Cuffini, Silvia L. Rocha, Helvecio V. A. |
author2_role |
author author author author author author author |
dc.contributor.none.fl_str_mv |
Lab Farmaceut Marinha Farmanguinhos Fiocruz Universidade Federal Fluminense (UFF) Universidade Federal de São Paulo (UNIFESP) Universidade Estadual Paulista (Unesp) Univ Nacl Cordoba Consejo Nacl Invest Cient & Tecn |
dc.contributor.author.fl_str_mv |
Testa, Carla G. Prado, Livia D. Costa, Rogeria N. Costa, Michelle L. [UNESP] Linck, Yamila G. Monti, Gustavo A. Cuffini, Silvia L. Rocha, Helvecio V. A. |
dc.subject.por.fl_str_mv |
Olanzapine Polymorphism X-ray diffraction Thermal analysis Solid state nuclear magnetic resonance |
topic |
Olanzapine Polymorphism X-ray diffraction Thermal analysis Solid state nuclear magnetic resonance |
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 |
2019-10-04T12:34:27Z 2019-10-04T12:34:27Z 2019-02-10 |
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://dx.doi.org/10.1016/j.ijpharm.2018.12.008 International Journal Of Pharmaceutics. Amsterdam: Elsevier Science Bv, v. 556, p. 125-135, 2019. 0378-5173 http://hdl.handle.net/11449/185322 10.1016/j.ijpharm.2018.12.008 WOS:000455968700013 |
url |
http://dx.doi.org/10.1016/j.ijpharm.2018.12.008 http://hdl.handle.net/11449/185322 |
identifier_str_mv |
International Journal Of Pharmaceutics. Amsterdam: Elsevier Science Bv, v. 556, p. 125-135, 2019. 0378-5173 10.1016/j.ijpharm.2018.12.008 WOS:000455968700013 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
International Journal Of Pharmaceutics |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
125-135 |
dc.publisher.none.fl_str_mv |
Elsevier B.V. |
publisher.none.fl_str_mv |
Elsevier B.V. |
dc.source.none.fl_str_mv |
Web of Science reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1808128737411072000 |