The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components

Autores
Melian, Elisa; Munguía, A. Beatriz; Faccio Sgiorovello, Ricardo Juan; Palma, Santiago Daniel; Domínguez, Laura
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Purpose: Solid dispersions (SDs) of a poorly water-soluble drug were prepared, and their physicochemical properties were compared to those of control physical mixtures (PMs). Among the multiple techniques used to characterize the solid state of preparations, confocal micro Raman spectroscopy (CMRS) was used as a non-destructive tool to qualitatively probe content uniformity and distribution of drug and carrier. Methods: SDs and PMs of drug (fenbendazole, FBZ) were prepared containing two different carriers (poloxamer P188 or P407) with different drug polymer ratios. The preparations were characterized by powder X-ray diffractometry, Fourier transform infrared spectroscopy, thermal analysis, scanning electron microscopy, and in vitro dissolution assay. In addition, CMRS technique and principal component analysis (PCA) were used in order to statistically define the content uniformity and distribution of the drug within the polymeric matrix. Results: In vitro dissolution results exhibited a marked improvement when the drug was formulated as SD compared to control PM and to pure drug. The solid state of these preparations characterized by X-ray powder diffraction and Fourier transform infrared spectroscopy showed no changes in the crystalline state of the drug and no chemical interactions between the components. Raman studies showed a better content uniformity of the drug within the polymeric matrix when subjected to SD process, correlating with the improved dissolution profile. Conclusion: This study provides evidence of the potential of the confocal Raman imaging technique, providing a fast and powerful method to characterize solid dispersions which could be incorporated towards the use of quality by design (QbD) approaches in pharmaceutical development.
Fil: Melian, Elisa. Universidad de la República; Uruguay
Fil: Munguía, A. Beatriz. Universidad de la República; Uruguay
Fil: Faccio Sgiorovello, Ricardo Juan. Universidad de la República; Uruguay
Fil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Domínguez, Laura. Universidad de la República; Uruguay
Materia
CONFOCAL MICRO RAMAN SPECTROSCOPY
CONTENT UNIFORMITY
DISSOLUTION RATE
SOLID DISPERSION
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:11336/65693
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of ComponentsMelian, ElisaMunguía, A. BeatrizFaccio Sgiorovello, Ricardo JuanPalma, Santiago DanielDomínguez, LauraCONFOCAL MICRO RAMAN SPECTROSCOPYCONTENT UNIFORMITYDISSOLUTION RATESOLID DISPERSIONhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Purpose: Solid dispersions (SDs) of a poorly water-soluble drug were prepared, and their physicochemical properties were compared to those of control physical mixtures (PMs). Among the multiple techniques used to characterize the solid state of preparations, confocal micro Raman spectroscopy (CMRS) was used as a non-destructive tool to qualitatively probe content uniformity and distribution of drug and carrier. Methods: SDs and PMs of drug (fenbendazole, FBZ) were prepared containing two different carriers (poloxamer P188 or P407) with different drug polymer ratios. The preparations were characterized by powder X-ray diffractometry, Fourier transform infrared spectroscopy, thermal analysis, scanning electron microscopy, and in vitro dissolution assay. In addition, CMRS technique and principal component analysis (PCA) were used in order to statistically define the content uniformity and distribution of the drug within the polymeric matrix. Results: In vitro dissolution results exhibited a marked improvement when the drug was formulated as SD compared to control PM and to pure drug. The solid state of these preparations characterized by X-ray powder diffraction and Fourier transform infrared spectroscopy showed no changes in the crystalline state of the drug and no chemical interactions between the components. Raman studies showed a better content uniformity of the drug within the polymeric matrix when subjected to SD process, correlating with the improved dissolution profile. Conclusion: This study provides evidence of the potential of the confocal Raman imaging technique, providing a fast and powerful method to characterize solid dispersions which could be incorporated towards the use of quality by design (QbD) approaches in pharmaceutical development.Fil: Melian, Elisa. Universidad de la República; UruguayFil: Munguía, A. Beatriz. Universidad de la República; UruguayFil: Faccio Sgiorovello, Ricardo Juan. Universidad de la República; UruguayFil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Domínguez, Laura. Universidad de la República; UruguaySpringer2018-03-16info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/65693Melian, Elisa; Munguía, A. Beatriz; Faccio Sgiorovello, Ricardo Juan; Palma, Santiago Daniel; Domínguez, Laura; The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components; Springer; Journal of Pharmaceutical Innovation; 13; 1; 16-3-2018; 58-681939-8042CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://link.springer.com/10.1007/s12247-017-9306-9info:eu-repo/semantics/altIdentifier/doi/10.1007/s12247-017-9306-9info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:42:09Zoai:ri.conicet.gov.ar:11336/65693instacron: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 09:42:10.198CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
title The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
spellingShingle The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
Melian, Elisa
CONFOCAL MICRO RAMAN SPECTROSCOPY
CONTENT UNIFORMITY
DISSOLUTION RATE
SOLID DISPERSION
title_short The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
title_full The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
title_fullStr The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
title_full_unstemmed The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
title_sort The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components
dc.creator.none.fl_str_mv Melian, Elisa
Munguía, A. Beatriz
Faccio Sgiorovello, Ricardo Juan
Palma, Santiago Daniel
Domínguez, Laura
author Melian, Elisa
author_facet Melian, Elisa
Munguía, A. Beatriz
Faccio Sgiorovello, Ricardo Juan
Palma, Santiago Daniel
Domínguez, Laura
author_role author
author2 Munguía, A. Beatriz
Faccio Sgiorovello, Ricardo Juan
Palma, Santiago Daniel
Domínguez, Laura
author2_role author
author
author
author
dc.subject.none.fl_str_mv CONFOCAL MICRO RAMAN SPECTROSCOPY
CONTENT UNIFORMITY
DISSOLUTION RATE
SOLID DISPERSION
topic CONFOCAL MICRO RAMAN SPECTROSCOPY
CONTENT UNIFORMITY
DISSOLUTION RATE
SOLID DISPERSION
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Purpose: Solid dispersions (SDs) of a poorly water-soluble drug were prepared, and their physicochemical properties were compared to those of control physical mixtures (PMs). Among the multiple techniques used to characterize the solid state of preparations, confocal micro Raman spectroscopy (CMRS) was used as a non-destructive tool to qualitatively probe content uniformity and distribution of drug and carrier. Methods: SDs and PMs of drug (fenbendazole, FBZ) were prepared containing two different carriers (poloxamer P188 or P407) with different drug polymer ratios. The preparations were characterized by powder X-ray diffractometry, Fourier transform infrared spectroscopy, thermal analysis, scanning electron microscopy, and in vitro dissolution assay. In addition, CMRS technique and principal component analysis (PCA) were used in order to statistically define the content uniformity and distribution of the drug within the polymeric matrix. Results: In vitro dissolution results exhibited a marked improvement when the drug was formulated as SD compared to control PM and to pure drug. The solid state of these preparations characterized by X-ray powder diffraction and Fourier transform infrared spectroscopy showed no changes in the crystalline state of the drug and no chemical interactions between the components. Raman studies showed a better content uniformity of the drug within the polymeric matrix when subjected to SD process, correlating with the improved dissolution profile. Conclusion: This study provides evidence of the potential of the confocal Raman imaging technique, providing a fast and powerful method to characterize solid dispersions which could be incorporated towards the use of quality by design (QbD) approaches in pharmaceutical development.
Fil: Melian, Elisa. Universidad de la República; Uruguay
Fil: Munguía, A. Beatriz. Universidad de la República; Uruguay
Fil: Faccio Sgiorovello, Ricardo Juan. Universidad de la República; Uruguay
Fil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Domínguez, Laura. Universidad de la República; Uruguay
description Purpose: Solid dispersions (SDs) of a poorly water-soluble drug were prepared, and their physicochemical properties were compared to those of control physical mixtures (PMs). Among the multiple techniques used to characterize the solid state of preparations, confocal micro Raman spectroscopy (CMRS) was used as a non-destructive tool to qualitatively probe content uniformity and distribution of drug and carrier. Methods: SDs and PMs of drug (fenbendazole, FBZ) were prepared containing two different carriers (poloxamer P188 or P407) with different drug polymer ratios. The preparations were characterized by powder X-ray diffractometry, Fourier transform infrared spectroscopy, thermal analysis, scanning electron microscopy, and in vitro dissolution assay. In addition, CMRS technique and principal component analysis (PCA) were used in order to statistically define the content uniformity and distribution of the drug within the polymeric matrix. Results: In vitro dissolution results exhibited a marked improvement when the drug was formulated as SD compared to control PM and to pure drug. The solid state of these preparations characterized by X-ray powder diffraction and Fourier transform infrared spectroscopy showed no changes in the crystalline state of the drug and no chemical interactions between the components. Raman studies showed a better content uniformity of the drug within the polymeric matrix when subjected to SD process, correlating with the improved dissolution profile. Conclusion: This study provides evidence of the potential of the confocal Raman imaging technique, providing a fast and powerful method to characterize solid dispersions which could be incorporated towards the use of quality by design (QbD) approaches in pharmaceutical development.
publishDate 2018
dc.date.none.fl_str_mv 2018-03-16
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/11336/65693
Melian, Elisa; Munguía, A. Beatriz; Faccio Sgiorovello, Ricardo Juan; Palma, Santiago Daniel; Domínguez, Laura; The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components; Springer; Journal of Pharmaceutical Innovation; 13; 1; 16-3-2018; 58-68
1939-8042
CONICET Digital
CONICET
url http://hdl.handle.net/11336/65693
identifier_str_mv Melian, Elisa; Munguía, A. Beatriz; Faccio Sgiorovello, Ricardo Juan; Palma, Santiago Daniel; Domínguez, Laura; The Impact of Solid Dispersion on Formulation, Using Confocal Micro Raman Spectroscopy as Tool to Probe Distribution of Components; Springer; Journal of Pharmaceutical Innovation; 13; 1; 16-3-2018; 58-68
1939-8042
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://link.springer.com/10.1007/s12247-017-9306-9
info:eu-repo/semantics/altIdentifier/doi/10.1007/s12247-017-9306-9
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 Springer
publisher.none.fl_str_mv Springer
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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