Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol

Autores
Han, Yong; Faudone, Sonia Nerina; Zitto, Gustavo; Bonafede, Silvina; Rosasco, María Ana; Segall, Adriana Ines
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the dissolution profile of diclofenac potassium by formation of a physical mixture and a solid dispersion with mannitol. The solid dispersion was prepared by solvent method using ethanol/water. As diclofenac potassium melts with decomposition, the compatibility study with mannitol was done with the acid form by differential scanning calorimetry (DSC). The dissolution properties and physicochemical properties of diclofenac potassium:mannitol physical mixture and solid dispersion were investigated by Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM) and dissolution test. This study shows that the dissolution rate of diclofenac potassium can be enhanced considerably by formulating it with mannitol, as a physical mixture or as a solid dispersion although crystallinity was maintained.
Fil: Han, Yong. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Faudone, Sonia Nerina. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; Argentina
Fil: Zitto, Gustavo. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; Argentina
Fil: Bonafede, Silvina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Rosasco, María Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
solid dispersio
diclofenac potassium
mannitol
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/47961
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/47961
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with MannitolHan, YongFaudone, Sonia NerinaZitto, GustavoBonafede, SilvinaRosasco, María AnaSegall, Adriana Inessolid dispersiodiclofenac potassiummannitolhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the dissolution profile of diclofenac potassium by formation of a physical mixture and a solid dispersion with mannitol. The solid dispersion was prepared by solvent method using ethanol/water. As diclofenac potassium melts with decomposition, the compatibility study with mannitol was done with the acid form by differential scanning calorimetry (DSC). The dissolution properties and physicochemical properties of diclofenac potassium:mannitol physical mixture and solid dispersion were investigated by Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM) and dissolution test. This study shows that the dissolution rate of diclofenac potassium can be enhanced considerably by formulating it with mannitol, as a physical mixture or as a solid dispersion although crystallinity was maintained.Fil: Han, Yong. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Faudone, Sonia Nerina. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; ArgentinaFil: Zitto, Gustavo. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; ArgentinaFil: Bonafede, Silvina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Rosasco, María Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; ArgentinaFil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaJAPSonlines2017-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/47961Han, Yong; Faudone, Sonia Nerina; Zitto, Gustavo; Bonafede, Silvina; Rosasco, María Ana; et al.; Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol; JAPSonlines; Journal of Applied Pharmaceutical Science; 7; 1; 1-2017; 204-2082231-3354CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.7324/JAPS.2017.70130info:eu-repo/semantics/altIdentifier/url/http://www.japsonline.com/abstract.php?article_id=2140info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:02:22Zoai:ri.conicet.gov.ar:11336/47961instacron: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 10:02:22.304CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
title Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
spellingShingle Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
Han, Yong
solid dispersio
diclofenac potassium
mannitol
title_short Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
title_full Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
title_fullStr Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
title_full_unstemmed Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
title_sort Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol
dc.creator.none.fl_str_mv Han, Yong
Faudone, Sonia Nerina
Zitto, Gustavo
Bonafede, Silvina
Rosasco, María Ana
Segall, Adriana Ines
author Han, Yong
author_facet Han, Yong
Faudone, Sonia Nerina
Zitto, Gustavo
Bonafede, Silvina
Rosasco, María Ana
Segall, Adriana Ines
author_role author
author2 Faudone, Sonia Nerina
Zitto, Gustavo
Bonafede, Silvina
Rosasco, María Ana
Segall, Adriana Ines
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv solid dispersio
diclofenac potassium
mannitol
topic solid dispersio
diclofenac potassium
mannitol
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the dissolution profile of diclofenac potassium by formation of a physical mixture and a solid dispersion with mannitol. The solid dispersion was prepared by solvent method using ethanol/water. As diclofenac potassium melts with decomposition, the compatibility study with mannitol was done with the acid form by differential scanning calorimetry (DSC). The dissolution properties and physicochemical properties of diclofenac potassium:mannitol physical mixture and solid dispersion were investigated by Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM) and dissolution test. This study shows that the dissolution rate of diclofenac potassium can be enhanced considerably by formulating it with mannitol, as a physical mixture or as a solid dispersion although crystallinity was maintained.
Fil: Han, Yong. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Faudone, Sonia Nerina. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; Argentina
Fil: Zitto, Gustavo. Provincia de Córdoba. Ministerio de Ciencia y Técnica. Centro de Excelencia en Productos y Procesos de Córdoba; Argentina
Fil: Bonafede, Silvina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Rosasco, María Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Laboratorio de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the dissolution profile of diclofenac potassium by formation of a physical mixture and a solid dispersion with mannitol. The solid dispersion was prepared by solvent method using ethanol/water. As diclofenac potassium melts with decomposition, the compatibility study with mannitol was done with the acid form by differential scanning calorimetry (DSC). The dissolution properties and physicochemical properties of diclofenac potassium:mannitol physical mixture and solid dispersion were investigated by Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM) and dissolution test. This study shows that the dissolution rate of diclofenac potassium can be enhanced considerably by formulating it with mannitol, as a physical mixture or as a solid dispersion although crystallinity was maintained.
publishDate 2017
dc.date.none.fl_str_mv 2017-01
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/11336/47961
Han, Yong; Faudone, Sonia Nerina; Zitto, Gustavo; Bonafede, Silvina; Rosasco, María Ana; et al.; Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol; JAPSonlines; Journal of Applied Pharmaceutical Science; 7; 1; 1-2017; 204-208
2231-3354
CONICET Digital
CONICET
url http://hdl.handle.net/11336/47961
identifier_str_mv Han, Yong; Faudone, Sonia Nerina; Zitto, Gustavo; Bonafede, Silvina; Rosasco, María Ana; et al.; Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol; JAPSonlines; Journal of Applied Pharmaceutical Science; 7; 1; 1-2017; 204-208
2231-3354
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.7324/JAPS.2017.70130
info:eu-repo/semantics/altIdentifier/url/http://www.japsonline.com/abstract.php?article_id=2140
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv JAPSonlines
publisher.none.fl_str_mv JAPSonlines
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 13.070432

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