Evaluation of the pharmaceutical equivalence of metamizole 500 mg tablets
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Data de Publicação: | 2020 |
Outros Autores: | , |
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. |
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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 |