Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide

Understanding the phase behavior of active pharmaceutical ingredients is important for formulations of dosage forms and regulatory reasons. Nimesulide is an anti-inflammatory drug that is known to exhibit dimorphism; however up to now its stability behavior was not clear, as few thermodynamic data w...

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Autores: Barrio Casado, María del|||0000-0003-3467-7581, Huguet, Jordi, Robert, B., Rietveld, Ivo B., Céolin, René, Tamarit Mur, José Luis|||0000-0002-7965-0000
Tipo de recurso: artículo
Fecha de publicación:2017
País:España
Institución:Universitat Politècnica de Catalunya (UPC)
Repositorio:UPCommons. Portal del coneixement obert de la UPC
Idioma:inglés
OAI Identifier:oai:upcommons.upc.edu:2117/104659
Acceso en línea:https://hdl.handle.net/2117/104659
https://dx.doi.org/10.1016/j.ijpharm.2017.04.016
Access Level:acceso abierto
Palabra clave:Calorimetry
Crystallography
Polymorphism (Crystallography)
Thermodynamics
Polymorphism
Pressure-temperature phase diagram
Phase behavior
Preformulation
Termodinàmica
Cristal·lografia
Calorimetria
Polimorfisme (Cristal·lografia)
Àrees temàtiques de la UPC::Física
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spelling Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulideBarrio Casado, María del|||0000-0003-3467-7581Huguet, JordiRobert, B.Rietveld, Ivo B.Céolin, RenéTamarit Mur, José Luis|||0000-0002-7965-0000CalorimetryCrystallographyPolymorphism (Crystallography)ThermodynamicsPolymorphismThermodynamicsPressure-temperature phase diagramPhase behaviorCrystallographyCalorimetryPreformulationTermodinàmicaCristal·lografiaCalorimetriaPolimorfisme (Cristal·lografia)Àrees temàtiques de la UPC::FísicaUnderstanding the phase behavior of active pharmaceutical ingredients is important for formulations of dosage forms and regulatory reasons. Nimesulide is an anti-inflammatory drug that is known to exhibit dimorphism; however up to now its stability behavior was not clear, as few thermodynamic data were available. Therefore, calorimetric melting data have been obtained, which were found to be TI-L = 422.4 ± 1.0 K, ¿I ¿ LH = 117.5 ± 5.2 J g-1, TII-L = 419.8 ± 1.0 K and ¿II ¿ LH = 108.6 ± 3.3 J g-1. In addition, vapor-pressure data, high-pressure melting data, and specific volumes have been obtained. It is demonstrated that form II is intrinsically monotropic in relation to form I and the latter would thus be the best polymorph to use for drug formulations. This result has been obtained by experimental means, involving high-pressure measurements. Furthermore, it has been shown that with very limited experimental and statistical data, the same conclusion can be obtained, demonstrating that in first instance topological pressure-temperature phase diagrams can be obtained without necessarily measuring any high-pressure data. It provides a quick method to verify the phase behavior of the known phases of an active pharmaceutical ingredient under different pressure and temperature conditions.20172017-06-1520172017-05-19journal articlehttp://purl.org/coar/resource_type/c_6501AMhttp://purl.org/coar/version/c_ab4af688f83e57aainfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/2117/104659https://dx.doi.org/10.1016/j.ijpharm.2017.04.016reponame:UPCommons. Portal del coneixement obert de la UPCinstname:Universitat Politècnica de Catalunya (UPC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:upcommons.upc.edu:2117/1046592026-05-27T15:37:01Z
dc.title.none.fl_str_mv Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
title Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
spellingShingle Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
Barrio Casado, María del|||0000-0003-3467-7581
Calorimetry
Crystallography
Polymorphism (Crystallography)
Thermodynamics
Polymorphism
Thermodynamics
Pressure-temperature phase diagram
Phase behavior
Crystallography
Calorimetry
Preformulation
Termodinàmica
Cristal·lografia
Calorimetria
Polimorfisme (Cristal·lografia)
Àrees temàtiques de la UPC::Física
title_short Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
title_full Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
title_fullStr Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
title_full_unstemmed Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
title_sort Pressure-temperature phase diagram of the dimorphism of the anti-inflammatory drug nimesulide
dc.creator.none.fl_str_mv Barrio Casado, María del|||0000-0003-3467-7581
Huguet, Jordi
Robert, B.
Rietveld, Ivo B.
Céolin, René
Tamarit Mur, José Luis|||0000-0002-7965-0000
author Barrio Casado, María del|||0000-0003-3467-7581
author_facet Barrio Casado, María del|||0000-0003-3467-7581
Huguet, Jordi
Robert, B.
Rietveld, Ivo B.
Céolin, René
Tamarit Mur, José Luis|||0000-0002-7965-0000
author_role author
author2 Huguet, Jordi
Robert, B.
Rietveld, Ivo B.
Céolin, René
Tamarit Mur, José Luis|||0000-0002-7965-0000
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv Calorimetry
Crystallography
Polymorphism (Crystallography)
Thermodynamics
Polymorphism
Thermodynamics
Pressure-temperature phase diagram
Phase behavior
Crystallography
Calorimetry
Preformulation
Termodinàmica
Cristal·lografia
Calorimetria
Polimorfisme (Cristal·lografia)
Àrees temàtiques de la UPC::Física
topic Calorimetry
Crystallography
Polymorphism (Crystallography)
Thermodynamics
Polymorphism
Thermodynamics
Pressure-temperature phase diagram
Phase behavior
Crystallography
Calorimetry
Preformulation
Termodinàmica
Cristal·lografia
Calorimetria
Polimorfisme (Cristal·lografia)
Àrees temàtiques de la UPC::Física
description Understanding the phase behavior of active pharmaceutical ingredients is important for formulations of dosage forms and regulatory reasons. Nimesulide is an anti-inflammatory drug that is known to exhibit dimorphism; however up to now its stability behavior was not clear, as few thermodynamic data were available. Therefore, calorimetric melting data have been obtained, which were found to be TI-L = 422.4 ± 1.0 K, ¿I ¿ LH = 117.5 ± 5.2 J g-1, TII-L = 419.8 ± 1.0 K and ¿II ¿ LH = 108.6 ± 3.3 J g-1. In addition, vapor-pressure data, high-pressure melting data, and specific volumes have been obtained. It is demonstrated that form II is intrinsically monotropic in relation to form I and the latter would thus be the best polymorph to use for drug formulations. This result has been obtained by experimental means, involving high-pressure measurements. Furthermore, it has been shown that with very limited experimental and statistical data, the same conclusion can be obtained, demonstrating that in first instance topological pressure-temperature phase diagrams can be obtained without necessarily measuring any high-pressure data. It provides a quick method to verify the phase behavior of the known phases of an active pharmaceutical ingredient under different pressure and temperature conditions.
publishDate 2017
dc.date.none.fl_str_mv 2017
2017-06-15
2017
2017-05-19
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
AM
http://purl.org/coar/version/c_ab4af688f83e57aa
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/2117/104659
https://dx.doi.org/10.1016/j.ijpharm.2017.04.016
url https://hdl.handle.net/2117/104659
https://dx.doi.org/10.1016/j.ijpharm.2017.04.016
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:UPCommons. Portal del coneixement obert de la UPC
instname:Universitat Politècnica de Catalunya (UPC)
instname_str Universitat Politècnica de Catalunya (UPC)
reponame_str UPCommons. Portal del coneixement obert de la UPC
collection UPCommons. Portal del coneixement obert de la UPC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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