Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets

Detalhes bibliográficos
Autor(a) principal: Heinzen, Crislaine Luz
Data de Publicação: 2020
Outros Autores: Miranda, Nathielle, Hoscheid, Jaqueline
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/11219
Resumo: The drug metamizole is a drug widely used by the Brazilian population, mainly due to its pharmacological actions such as analgesics, anti-inflammatory and antipyretic. In Brazil, the three main classes of circulation drugs are considered, being the reference, generic and similar. The quality control of medicines in the pharmaceutical industries is of great importance, as it provides the quality and safety to consumers. In view of the importance of guaranteeing the efficacy of the drug to the population, the present study aimed to evaluate a pharmaceutical equivalence of the three classes of the drug metamizole in a solid pharmaceutical form of tablets and a concentration of 500 mg. The tests carried out followed the methodologies carried out in the 6th edition of the Brazilian Pharmacopoeia, being carried out the identification tests, average weight, hardness, friability, disintegration time and dosage. The results of the analyzes show that the tested ones fulfill the pharmacopoeial specifications and can be derived from pharmacists, therefore, this study reinforces the need for updated research, as well as corroborates with the dissemination of information on this theme.
id UNIFEI_808516ad6908783a54e01351e9b79c18
oai_identifier_str oai:ojs.pkp.sfu.ca:article/11219
network_acronym_str UNIFEI
network_name_str Research, Society and Development
repository_id_str
spelling Evaluation of the pharmaceutical equivalence of metamizole 500 mg tabletsEvaluación de la equivalencia farmacéutica de comprimidos de monohidrato de dipirona de 500 mgAvaliação da equivalência farmacêutica de comprimidos de dipirona monoidratada 500 mgGeneric drugSimilar drugReference listed drugMetamizoleQuality control.GenéricoSimilarReferênciaDipirona sódicaControle de qualidade.GenéricoSimilarReferenciaDipirona sódicaControl de calidad.The drug metamizole is a drug widely used by the Brazilian population, mainly due to its pharmacological actions such as analgesics, anti-inflammatory and antipyretic. In Brazil, the three main classes of circulation drugs are considered, being the reference, generic and similar. The quality control of medicines in the pharmaceutical industries is of great importance, as it provides the quality and safety to consumers. In view of the importance of guaranteeing the efficacy of the drug to the population, the present study aimed to evaluate a pharmaceutical equivalence of the three classes of the drug metamizole in a solid pharmaceutical form of tablets and a concentration of 500 mg. The tests carried out followed the methodologies carried out in the 6th edition of the Brazilian Pharmacopoeia, being carried out the identification tests, average weight, hardness, friability, disintegration time and dosage. The results of the analyzes show that the tested ones fulfill the pharmacopoeial specifications and can be derived from pharmacists, therefore, this study reinforces the need for updated research, as well as corroborates with the dissemination of information on this theme.El fármaco dipirona es un fármaco ampliamente utilizado por la población brasileña, principalmente debido a sus acciones farmacológicas como analgésicos, antiinflamatorios y antipiréticos. En Brasil, se consideran tres clases principales de medicamentos de circulación, siendo la referencia, genéricos y similares. El control de calidad de los medicamentos en las industrias farmacéuticas es de gran importancia, ya que garantiza la calidad y seguridad a los consumidores. Dada la importancia de garantizar la eficacia del medicamento a la población, el presente estudio tuvo como objetivo evaluar la equivalencia farmacéutica de las tres clases del medicamento Monohidrato de dipirona en la forma farmacéutica sólida de tabletas y una concentración de 500 mg. Las pruebas realizadas siguieron las metodologías descritas en la 6ª edición de la Farmacopea Brasileña, con pruebas de identificación, peso medio, dureza, friabilidad, tiempo de desintegración, y dosificación. Los resultados de los análisis obtenidos muestran que las muestras analizadas cumplen con las especificaciones de la farmacopea y pueden considerarse equivalentes farmacéuticos, por lo que este estudio refuerza la necesidad de una investigación actualizada, además de corroborar la difusión de información sobre este tema.O medicamento dipirona é um fármaco muito utilizado pela população brasileira, principalmente devido as suas ações farmacológicas analgésicas, anti-inflamatórias e antitérmica. No Brasil, são consideradas três principais classes de medicamentos de circulação, sendo os de referência, genéricos e similares. O controle de qualidade de medicamentos nas indústrias farmacêuticas é de grande importância, pois assegura a qualidade e segurança aos consumidores por garantir a dose apropriada. Visto a importância de se garantir a eficácia do medicamento à população, o presente trabalho teve por objetivo avaliar a equivalência farmacêutica das três classes do medicamento dipirona monoidratada na forma farmacêutica sólida do tipo comprimidos e concentração de 500 mg.  Os ensaios realizados seguiram as metodologias descritas na 6° edição da Farmacopeia Brasileira, sendo realizados os testes de identificação, peso médio, dureza, friabilidade, tempo de desintegração, e doseamento. Os resultados das análises obtidos mostram que as amostras testadas cumprem as especificações farmacopeicas e podem ser consideradas equivalentes farmacêuticos, portanto, este estudo reforça a necessidade de pesquisas atualizadas, assim como corrobora com a disseminação de informações sobre esta temática.Research, Society and Development2020-12-29info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/1121910.33448/rsd-v9i12.11219Research, Society and Development; Vol. 9 No. 12; e46491211219Research, Society and Development; Vol. 9 Núm. 12; e46491211219Research, Society and Development; v. 9 n. 12; e464912112192525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/11219/10116Copyright (c) 2020 Crislaine Luz Heinzen; Nathielle Miranda; Jaqueline Hoscheidhttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessHeinzen, Crislaine Luz Miranda, NathielleHoscheid, Jaqueline2020-12-30T23:32:22Zoai:ojs.pkp.sfu.ca:article/11219Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:33:06.475121Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
Evaluación de la equivalencia farmacéutica de comprimidos de monohidrato de dipirona de 500 mg
Avaliação da equivalência farmacêutica de comprimidos de dipirona monoidratada 500 mg
title Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
spellingShingle Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
Heinzen, Crislaine Luz
Generic drug
Similar drug
Reference listed drug
Metamizole
Quality control.
Genérico
Similar
Referência
Dipirona sódica
Controle de qualidade.
Genérico
Similar
Referencia
Dipirona sódica
Control de calidad.
title_short Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
title_full Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
title_fullStr Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
title_full_unstemmed Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
title_sort Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
author Heinzen, Crislaine Luz
author_facet Heinzen, Crislaine Luz
Miranda, Nathielle
Hoscheid, Jaqueline
author_role author
author2 Miranda, Nathielle
Hoscheid, Jaqueline
author2_role author
author
dc.contributor.author.fl_str_mv Heinzen, Crislaine Luz
Miranda, Nathielle
Hoscheid, Jaqueline
dc.subject.por.fl_str_mv Generic drug
Similar drug
Reference listed drug
Metamizole
Quality control.
Genérico
Similar
Referência
Dipirona sódica
Controle de qualidade.
Genérico
Similar
Referencia
Dipirona sódica
Control de calidad.
topic Generic drug
Similar drug
Reference listed drug
Metamizole
Quality control.
Genérico
Similar
Referência
Dipirona sódica
Controle de qualidade.
Genérico
Similar
Referencia
Dipirona sódica
Control de calidad.
description The drug metamizole is a drug widely used by the Brazilian population, mainly due to its pharmacological actions such as analgesics, anti-inflammatory and antipyretic. In Brazil, the three main classes of circulation drugs are considered, being the reference, generic and similar. The quality control of medicines in the pharmaceutical industries is of great importance, as it provides the quality and safety to consumers. In view of the importance of guaranteeing the efficacy of the drug to the population, the present study aimed to evaluate a pharmaceutical equivalence of the three classes of the drug metamizole in a solid pharmaceutical form of tablets and a concentration of 500 mg. The tests carried out followed the methodologies carried out in the 6th edition of the Brazilian Pharmacopoeia, being carried out the identification tests, average weight, hardness, friability, disintegration time and dosage. The results of the analyzes show that the tested ones fulfill the pharmacopoeial specifications and can be derived from pharmacists, therefore, this study reinforces the need for updated research, as well as corroborates with the dissemination of information on this theme.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-29
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/11219
10.33448/rsd-v9i12.11219
url https://rsdjournal.org/index.php/rsd/article/view/11219
identifier_str_mv 10.33448/rsd-v9i12.11219
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/11219/10116
dc.rights.driver.fl_str_mv Copyright (c) 2020 Crislaine Luz Heinzen; Nathielle Miranda; Jaqueline Hoscheid
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2020 Crislaine Luz Heinzen; Nathielle Miranda; Jaqueline Hoscheid
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 9 No. 12; e46491211219
Research, Society and Development; Vol. 9 Núm. 12; e46491211219
Research, Society and Development; v. 9 n. 12; e46491211219
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
_version_ 1797052667130806272