Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923 |
Resumo: | Introduction: Heparin is a drug that has anticoagulant activity, binding to antithrombin and accelerating the rate of inhibition of several proteases involved in the coagulation process. In the 2000s, the world market faced a troubled period regarding heparins after reports of allergic reactions and deaths caused by its use, requiring more rigorous quality control. Objective: The main goal of this work was to perform quality control of unfractionated sodium heparins of porcine origin commercialized in Brazil and heparin raw material on a dry basis, of both porcine and bovine origin, through potency assays. Method: Sixty-four samples of the final product (commercialized) were analyzed: 39 of brand A and 25 of brand B, and six samples of raw materials. Samples were assayed through anti-factor Xa and anti-factor IIa, according to United States Pharmacopeia (USP), and coagulation assay, described in the 5th edition of Brazilian Pharmacopeia (BP). Results: In the present study, 40 heparin samples were approved in all potency assays, while 24 samples were non-approved, 23 of brand A and one of brand B. All samples of porcine-origin raw materials were considered approved, while the three of bovine origin showed lower potency. Conclusions: Almost all non-approved samples presented potency above 110%, which may represent a bleeding risk for patients. Thus, it is necessary to monitor the quality control of heparins and assess the clinical condition of patients undergoing their use to identify and reduce risks and safeguard public health. |
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Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Publicado em: 11/05/2023HeparinAnti-factor Xa AssayAnti-factor IIa AssayQuality ControlHuman HealthHeparinQuality ControlPotency AssayUnfractionated HeparinHeparinaEnsaio Antifator XaEnsaio Antifator IiaControle de QualidadeSaúde HumanaHeparinaControle de QualidadeEnsaio de PotênciaHeparina não-fracionadaIntroduction: Heparin is a drug that has anticoagulant activity, binding to antithrombin and accelerating the rate of inhibition of several proteases involved in the coagulation process. In the 2000s, the world market faced a troubled period regarding heparins after reports of allergic reactions and deaths caused by its use, requiring more rigorous quality control. Objective: The main goal of this work was to perform quality control of unfractionated sodium heparins of porcine origin commercialized in Brazil and heparin raw material on a dry basis, of both porcine and bovine origin, through potency assays. Method: Sixty-four samples of the final product (commercialized) were analyzed: 39 of brand A and 25 of brand B, and six samples of raw materials. Samples were assayed through anti-factor Xa and anti-factor IIa, according to United States Pharmacopeia (USP), and coagulation assay, described in the 5th edition of Brazilian Pharmacopeia (BP). Results: In the present study, 40 heparin samples were approved in all potency assays, while 24 samples were non-approved, 23 of brand A and one of brand B. All samples of porcine-origin raw materials were considered approved, while the three of bovine origin showed lower potency. Conclusions: Almost all non-approved samples presented potency above 110%, which may represent a bleeding risk for patients. Thus, it is necessary to monitor the quality control of heparins and assess the clinical condition of patients undergoing their use to identify and reduce risks and safeguard public health.TÍTULO PT: Avaliação da potência das heparinas não fracionadas comercializadas no Brasil por meio dos ensaios cromogênicos antifator Xa e antifator IIa e teste de coagulação Introdução: A heparina é um fármaco que apresenta atividade anticoagulante, ligando-se à antitrombina e acelerando a taxa de inibição de diversas proteases envolvidas no processo de coagulação. Na década de 2000, o mercado mundial enfrentou um período conturbado em relação às heparinas após relatos de reações alérgicas e de mortes causadas pelo seu uso, o que exigiu um controle de qualidade mais rigoroso. Objetivo: Realizar o controle de qualidade das heparinas sódicas não fracionadas de origem suína comercializadas no Brasil e da matéria-prima heparina em base seca, tanto de origem suína quanto bovina, por meio de ensaios de potência. Método: Foram analisadas 64 amostras do produto final (comercializado), sendo 39 da marca A e 25 da marca B, e seis amostras de matérias-primas. As amostras foram testadas por antifator Xa e antifator Iia, de acordo com a Farmacopeia dos Estados Unidos (USP), e por teste de coagulação, descrito na 5ª edição da Farmacopeia Brasileira (BP). Resultados: Quarenta amostras de heparina foram aprovadas em todos os ensaios de potência e 24 amostras não foram aprovadas, sendo 23 da marca A e uma da marca B. Todas as amostras de matérias-primas de origem suína foram consideradas aprovadas, enquanto as três de origem bovina apresentaram menor potência. Conclusões: Quase todas as amostras não aprovadas apresentaram potência acima de 110%, o que pode representar risco de sangramento para os pacientes. Assim, é necessário monitorar o controle de qualidade das heparinas e avaliar a condição clínica dos pacientes em uso para identificar e reduzir os riscos e salvaguardar a saúde pública.Instituto Nacional de Controle de Qualidade em Saúde2023-05-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/192310.22239/2317-269x.01923Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-10Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-10Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-102317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZengporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1496https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1602https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1550https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1551https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1552Copyright (c) 2023 Renata Jurema Medeiros, Nathália Pessoa Gonçalves, Magno Maciel Magalhães, João Ferreira Martins, Tiago Savignon Cardoso Machado (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessJurema Medeiros, RenataPessoa Gonçalves, NatháliaMaciel Magalhães, MagnoFerreira Martins, JoãoSavignon Cardoso Machado, Tiago2024-02-21T15:32:39Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1923Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-02-21T15:32:39Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Publicado em: 11/05/2023 |
title |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
spellingShingle |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 Jurema Medeiros, Renata Heparin Anti-factor Xa Assay Anti-factor IIa Assay Quality Control Human Health Heparin Quality Control Potency Assay Unfractionated Heparin Heparina Ensaio Antifator Xa Ensaio Antifator Iia Controle de Qualidade Saúde Humana Heparina Controle de Qualidade Ensaio de Potência Heparina não-fracionada |
title_short |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
title_full |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
title_fullStr |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
title_full_unstemmed |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
title_sort |
Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e01923 | Published on: 11/05/2023 |
author |
Jurema Medeiros, Renata |
author_facet |
Jurema Medeiros, Renata Pessoa Gonçalves, Nathália Maciel Magalhães, Magno Ferreira Martins, João Savignon Cardoso Machado, Tiago |
author_role |
author |
author2 |
Pessoa Gonçalves, Nathália Maciel Magalhães, Magno Ferreira Martins, João Savignon Cardoso Machado, Tiago |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Jurema Medeiros, Renata Pessoa Gonçalves, Nathália Maciel Magalhães, Magno Ferreira Martins, João Savignon Cardoso Machado, Tiago |
dc.subject.por.fl_str_mv |
Heparin Anti-factor Xa Assay Anti-factor IIa Assay Quality Control Human Health Heparin Quality Control Potency Assay Unfractionated Heparin Heparina Ensaio Antifator Xa Ensaio Antifator Iia Controle de Qualidade Saúde Humana Heparina Controle de Qualidade Ensaio de Potência Heparina não-fracionada |
topic |
Heparin Anti-factor Xa Assay Anti-factor IIa Assay Quality Control Human Health Heparin Quality Control Potency Assay Unfractionated Heparin Heparina Ensaio Antifator Xa Ensaio Antifator Iia Controle de Qualidade Saúde Humana Heparina Controle de Qualidade Ensaio de Potência Heparina não-fracionada |
description |
Introduction: Heparin is a drug that has anticoagulant activity, binding to antithrombin and accelerating the rate of inhibition of several proteases involved in the coagulation process. In the 2000s, the world market faced a troubled period regarding heparins after reports of allergic reactions and deaths caused by its use, requiring more rigorous quality control. Objective: The main goal of this work was to perform quality control of unfractionated sodium heparins of porcine origin commercialized in Brazil and heparin raw material on a dry basis, of both porcine and bovine origin, through potency assays. Method: Sixty-four samples of the final product (commercialized) were analyzed: 39 of brand A and 25 of brand B, and six samples of raw materials. Samples were assayed through anti-factor Xa and anti-factor IIa, according to United States Pharmacopeia (USP), and coagulation assay, described in the 5th edition of Brazilian Pharmacopeia (BP). Results: In the present study, 40 heparin samples were approved in all potency assays, while 24 samples were non-approved, 23 of brand A and one of brand B. All samples of porcine-origin raw materials were considered approved, while the three of bovine origin showed lower potency. Conclusions: Almost all non-approved samples presented potency above 110%, which may represent a bleeding risk for patients. Thus, it is necessary to monitor the quality control of heparins and assess the clinical condition of patients undergoing their use to identify and reduce risks and safeguard public health. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-05-11 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923 10.22239/2317-269x.01923 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923 |
identifier_str_mv |
10.22239/2317-269x.01923 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1496 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1602 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1550 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1551 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1923/1552 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-10 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-10 Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-10 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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