Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina

Autores
Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján
Año de publicación
2020
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.
Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Materia
ALLOPURINOL
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
DISSOLUTION PROFILE
PHARMACEUTICAL EQUIVALENCE
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:11336/129817
Acceder
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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in ArgentinaVarillas, María AlejandraBrevedan, Marta Ingrid VictoriaGonzález Vidal, Noelia LujánALLOPURINOLBIOPHARMACEUTICAL CLASSIFICATION SYSTEMDISSOLUTION PROFILEPHARMACEUTICAL EQUIVALENCEhttps://purl.org/becyt/ford/2.11https://purl.org/becyt/ford/2https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3https://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaDissolution Technologies, Inc2020-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/129817Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 27; 4; 11-2020; 16-231521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/info:eu-repo/semantics/altIdentifier/doi/10.14227/DT270420P15info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:09:08Zoai:ri.conicet.gov.ar:11336/129817instacron: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:34982025-09-03 10:09:09.15CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
title Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
spellingShingle Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
Varillas, María Alejandra
ALLOPURINOL
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
DISSOLUTION PROFILE
PHARMACEUTICAL EQUIVALENCE
title_short Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
title_full Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
title_fullStr Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
title_full_unstemmed Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
title_sort Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina
dc.creator.none.fl_str_mv Varillas, María Alejandra
Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author Varillas, María Alejandra
author_facet Varillas, María Alejandra
Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author_role author
author2 Brevedan, Marta Ingrid Victoria
González Vidal, Noelia Luján
author2_role author
author
dc.subject.none.fl_str_mv ALLOPURINOL
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
DISSOLUTION PROFILE
PHARMACEUTICAL EQUIVALENCE
topic ALLOPURINOL
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
DISSOLUTION PROFILE
PHARMACEUTICAL EQUIVALENCE
purl_subject.fl_str_mv https://purl.org/becyt/ford/2.11
https://purl.org/becyt/ford/2
https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.
Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina
description Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.
publishDate 2020
dc.date.none.fl_str_mv 2020-11
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/11336/129817
Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 27; 4; 11-2020; 16-23
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/129817
identifier_str_mv Varillas, María Alejandra; Brevedan, Marta Ingrid Victoria; González Vidal, Noelia Luján; Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina; Dissolution Technologies, Inc; Dissolution Technologies; 27; 4; 11-2020; 16-23
1521-298X
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT270420P15
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 Dissolution Technologies, Inc
publisher.none.fl_str_mv Dissolution Technologies, Inc
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
_version_ 1842270071092674560
score 13.13397

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