Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1768 |
Resumo: | Introduction: Dipyrone is a potent analgesic and antipyretic registered in the Brazilian List of Essential Medicines. Furthermore, it is strategically indicated in special cases, such as the palliative treatment of dengue, chikungunya, zika and COVID-19. Post-marketing problems have been identified for this drug, such as quality non-conformities, resulting in frequent withdrawals of medicines containing dipyrone by Anvisa. Objective: To investigate the quality and pharmaceutical equivalence of dipyrone tablets (reference, generics and similar), commercially available in Salvador-Bahia. Method: An experimental study was carried out using methodologies described in the Brazilian Pharmacopoeia 6th edition monograph of sodium dipyrone tablets. Three different brands were analyzed (one generic, two similar and one reference), all collected in Salvador-Bahia. In addition, an alternative analytical method by UV spectrophotometry was developed for the analysis of sodium dipyrone tablets, validated based on RDC No. 166/17. Results: The reference, generic and similar sodium dipyrone tablets met the requirements for identification and characteristics tests. A similar drug sample did not meet the dissolution test and only two generic samples were satisfactory for interchangeability. The assay pharmacopoeial method for dipyrone sodium tablets showed problems related to the analyst’s subjectivity and method uncertainty. The proposed alternative method proved to be selective, linear, precise, accurate, and robust, and indicated for the quantification of dipyrone in tablets. Conclusions: From the results obtained, it was observed that post-marketing monitoring of medicines with a population high consumption pattern, such as dipyrone, can signal issues to be investigated by health surveillance, with the objective of supporting its mission that is to protect population’s health. |
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Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicinesAvaliação biofarmacêutica de dipirona comprimido pós-comercialização: medicamentos de referência, genéricos e similaresDipyrone; Quality Control; Dissolution Profile; Analytical Method; Validationdipirona; control de calidad; perfil de disolución; método analítico; validación.Dipirona; Controle de Qualidade; Perfil de Dissolução; Método Analítico; ValidaçãoIntroduction: Dipyrone is a potent analgesic and antipyretic registered in the Brazilian List of Essential Medicines. Furthermore, it is strategically indicated in special cases, such as the palliative treatment of dengue, chikungunya, zika and COVID-19. Post-marketing problems have been identified for this drug, such as quality non-conformities, resulting in frequent withdrawals of medicines containing dipyrone by Anvisa. Objective: To investigate the quality and pharmaceutical equivalence of dipyrone tablets (reference, generics and similar), commercially available in Salvador-Bahia. Method: An experimental study was carried out using methodologies described in the Brazilian Pharmacopoeia 6th edition monograph of sodium dipyrone tablets. Three different brands were analyzed (one generic, two similar and one reference), all collected in Salvador-Bahia. In addition, an alternative analytical method by UV spectrophotometry was developed for the analysis of sodium dipyrone tablets, validated based on RDC No. 166/17. Results: The reference, generic and similar sodium dipyrone tablets met the requirements for identification and characteristics tests. A similar drug sample did not meet the dissolution test and only two generic samples were satisfactory for interchangeability. The assay pharmacopoeial method for dipyrone sodium tablets showed problems related to the analyst’s subjectivity and method uncertainty. The proposed alternative method proved to be selective, linear, precise, accurate, and robust, and indicated for the quantification of dipyrone in tablets. Conclusions: From the results obtained, it was observed that post-marketing monitoring of medicines with a population high consumption pattern, such as dipyrone, can signal issues to be investigated by health surveillance, with the objective of supporting its mission that is to protect population’s health.Introdução: A dipirona é um potente analgésico e antipirético inscrito na Relação Nacional de Medicamentos Essenciais. Ademais é estrategicamente indicada em casos especiais, como no tratamento paliativo de: dengue, chikungunya, zika e COVID-19. Problemas pós-comercialização, como não conformidades na qualidade, vêm sendo apontados para medicamentos contendo dipirona, resultando em recolhimentos frequentes pela Agência Nacional de Vigilância Sanitária. Objetivo: Averiguar a qualidade e a equivalência farmacêutica dos comprimidos de dipirona, referência, genéricos e similares, disponíveis comercialmente para a população da cidade de Salvador/BA. Método: Estudo experimental utilizando metodologias descritas na monografia da dipirona sódica comprimidos da Farmacopeia Brasileira 6ª edição. Foram analisadas três diferentes marcas de genérico, dois similares e o referência, coletadas no comércio da cidade de Salvador-Bahia. Adicionalmente, foi desenvolvido um método analítico alternativo por espectrofotometria na região ultravioleta para a análise da dipirona sódica comprimidos, validado com base na RDC n° 166, de 24 de julho de 2017. Resultados: Os comprimidos de dipirona sódica referência, genéricos e similares atenderam aos requisitos quanto aos testes de identificação e características. Uma amostra de medicamento similar não atendeu ao teste de dissolução e somente duas amostras, dos medicamentos genéricos, foram satisfatórias para a intercambialidade. O método farmacopeico para doseamento da dipirona sódica comprimidos demonstrou problemas relacionados à subjetividade do analista e a incerteza do método. O método alternativo proposto mostrou-se seletivo, linear, preciso, exato e robusto, indicado para a quantificação da dipirona em comprimidos. Conclusões: O monitoramento pós-comercialização de medicamentos com elevado padrão de consumo pela população, como a dipirona, pode sinalizar questões a serem investigadas pela vigilância sanitária, com o objetivo de apoiar sua missão de proteção à saúde da população.Instituto Nacional de Controle de Qualidade em Saúde2021-08-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/176810.22239/2317-269X.01768Health Surveillance under Debate: Society, Science & Technology ; Vol. 9 No. 3 (2021): August; 58-68Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 9 Núm. 3 (2021): Agosto; 58-68Vigil Sanit Debate, Rio de Janeiro; v. 9 n. 3 (2021): Agosto; 58-682317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1768/1342Copyright (c) 2021 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessSilva dos Santos, Eliane dos Santos Teles Cardoso, Amanda Cristina Laignier Cazedey, Edith 2023-06-27T15:13:38Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1768Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:13:38Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines Avaliação biofarmacêutica de dipirona comprimido pós-comercialização: medicamentos de referência, genéricos e similares |
title |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
spellingShingle |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines Silva dos Santos, Eliane Dipyrone; Quality Control; Dissolution Profile; Analytical Method; Validation dipirona; control de calidad; perfil de disolución; método analítico; validación. Dipirona; Controle de Qualidade; Perfil de Dissolução; Método Analítico; Validação |
title_short |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
title_full |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
title_fullStr |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
title_full_unstemmed |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
title_sort |
Post-marketing biopharmaceutical evaluation of dipyrone tablets: reference, generic and similar medicines |
author |
Silva dos Santos, Eliane |
author_facet |
Silva dos Santos, Eliane dos Santos Teles Cardoso, Amanda Cristina Laignier Cazedey, Edith |
author_role |
author |
author2 |
dos Santos Teles Cardoso, Amanda Cristina Laignier Cazedey, Edith |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Silva dos Santos, Eliane dos Santos Teles Cardoso, Amanda Cristina Laignier Cazedey, Edith |
dc.subject.por.fl_str_mv |
Dipyrone; Quality Control; Dissolution Profile; Analytical Method; Validation dipirona; control de calidad; perfil de disolución; método analítico; validación. Dipirona; Controle de Qualidade; Perfil de Dissolução; Método Analítico; Validação |
topic |
Dipyrone; Quality Control; Dissolution Profile; Analytical Method; Validation dipirona; control de calidad; perfil de disolución; método analítico; validación. Dipirona; Controle de Qualidade; Perfil de Dissolução; Método Analítico; Validação |
description |
Introduction: Dipyrone is a potent analgesic and antipyretic registered in the Brazilian List of Essential Medicines. Furthermore, it is strategically indicated in special cases, such as the palliative treatment of dengue, chikungunya, zika and COVID-19. Post-marketing problems have been identified for this drug, such as quality non-conformities, resulting in frequent withdrawals of medicines containing dipyrone by Anvisa. Objective: To investigate the quality and pharmaceutical equivalence of dipyrone tablets (reference, generics and similar), commercially available in Salvador-Bahia. Method: An experimental study was carried out using methodologies described in the Brazilian Pharmacopoeia 6th edition monograph of sodium dipyrone tablets. Three different brands were analyzed (one generic, two similar and one reference), all collected in Salvador-Bahia. In addition, an alternative analytical method by UV spectrophotometry was developed for the analysis of sodium dipyrone tablets, validated based on RDC No. 166/17. Results: The reference, generic and similar sodium dipyrone tablets met the requirements for identification and characteristics tests. A similar drug sample did not meet the dissolution test and only two generic samples were satisfactory for interchangeability. The assay pharmacopoeial method for dipyrone sodium tablets showed problems related to the analyst’s subjectivity and method uncertainty. The proposed alternative method proved to be selective, linear, precise, accurate, and robust, and indicated for the quantification of dipyrone in tablets. Conclusions: From the results obtained, it was observed that post-marketing monitoring of medicines with a population high consumption pattern, such as dipyrone, can signal issues to be investigated by health surveillance, with the objective of supporting its mission that is to protect population’s health. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-08-31 |
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/1768 10.22239/2317-269X.01768 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1768 |
identifier_str_mv |
10.22239/2317-269X.01768 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1768/1342 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc/4.0/ |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
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 ; Vol. 9 No. 3 (2021): August; 58-68 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 9 Núm. 3 (2021): Agosto; 58-68 Vigil Sanit Debate, Rio de Janeiro; v. 9 n. 3 (2021): Agosto; 58-68 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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1797042046469406720 |