Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®

Detalhes bibliográficos
Autor(a) principal: Trindade, Jéssica Aparecida Silva
Data de Publicação: 2021
Outros Autores: Rodrigues, Laura Virgínia Moreira, Oliveira, Samara Caroline Souza, Valadares, Ywia Danieli, Oliveira Júnior, Wander Valadares de, Cortez, Eduardo Nogueira, Mendonça, Thays Santos
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/16839
Resumo: This study aimed to compare the physical-chemical parameters of quality of the generic drug hydrochlorothiazide 25 mg in relation to the reference drug Clorana®. The following tests were performed: determination of average weight, identification, hardness, friability, disintegration, dissolution and dosing. All tests showed satisfactory results. In determining the average weight, the results obtained for both drugs showed little variation. In the identification test, the sample readings were in agreement with the standard. The hardness test was informative. The resistance to friction and impact of the tablets was within the parameters, so the friability was satisfactory. The hydrochlorothiazide tablets disintegrated in a longer time than those of Chlorana®, but within the established. Both drugs were dissolved within the precise time. In the dosing test, the content obtained was within the conformities. In view of the results of the tests of the physical-chemical tests, the study proved that the drugs are within the quality parameters and certified the safety in physical-chemical terms of the use of the generic drug tested in the treatment of Systemic Arterial Hypertension.
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spelling Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®Parámetros de calidad fisicoquímica del fármaco genérico hidroclorotiazida en relación con el fármaco de referencia Clorana®Parâmetros físico-químicos de qualidade do medicamento genérico hidroclorotiazida em relação ao medicamento de referência Clorana®Drugs, GenericHydrochlorothiazideHypertensionReference drugs.HidroclorotiazidaHipertensiónMedicamentos GenéricosMedicamentos de referencia.HidroclorotiazidaHipertensãoMedicamentos GenéricosMedicamentos de referência.This study aimed to compare the physical-chemical parameters of quality of the generic drug hydrochlorothiazide 25 mg in relation to the reference drug Clorana®. The following tests were performed: determination of average weight, identification, hardness, friability, disintegration, dissolution and dosing. All tests showed satisfactory results. In determining the average weight, the results obtained for both drugs showed little variation. In the identification test, the sample readings were in agreement with the standard. The hardness test was informative. The resistance to friction and impact of the tablets was within the parameters, so the friability was satisfactory. The hydrochlorothiazide tablets disintegrated in a longer time than those of Chlorana®, but within the established. Both drugs were dissolved within the precise time. In the dosing test, the content obtained was within the conformities. In view of the results of the tests of the physical-chemical tests, the study proved that the drugs are within the quality parameters and certified the safety in physical-chemical terms of the use of the generic drug tested in the treatment of Systemic Arterial Hypertension.Este estudio buscó comparar los parámetros de calidad fisicoquímica del fármaco genérico hidroclorotiazida 25 mg en relación al fármaco de referencia Clorana®. Se realizaron las siguientes pruebas: determinación de peso  medio, identificación, dureza, friabilidad, desintegración, disolución y dosificación. Todas las pruebas arrojaron resultados satisfactorios. Al determinar el peso promedio, los resultados obtenidos para los dos fármacos mostraron poca variación. En la prueba de identificación, las lecturas de la muestra coincidieron con el estándar. La prueba de dureza fue informativa. La resistencia a la fricción y al impacto de las tabletas estuvo dentro de los parámetros, por lo que la friabilidad fue satisfactoria. Las tabletas de hidroclorotiazida se desintegraron en más tiempo que las de Clorana®, pero dentro de los límites establecidos. Ambos fármacos se disolvieron en el tiempo preciso. En la prueba de dosificación, el contenido obtenido estuvo dentro del cumplimiento. A la vista de los resultados de las pruebas de los ensayos fisicoquímicos, el estudio demostró que los fármacos se encuentran dentro de los parámetros de calidad y certificó la seguridad en términos físico-químicos del uso del fármaco genérico testado en el tratamiento de la Hipertensión Arterial Sistémica.Este estudo possuiu o objetivo de comparar os parâmetros físico-químicos de qualidade do medicamento genérico hidroclorotiazida 25 mg em relação ao medicamento de referência Clorana®. Foram realizados os seguintes testes: determinação de peso médio, identificação, dureza, friabilidade, desintegração, dissolução e doseamento. Todos os testes apresentaram resultados satisfatórios. Na determinação do peso médio, os resultados obtidos para os dois medicamentos apresentaram pouca variação. No teste de identificação, as leituras das amostras estavam em concordância com o padrão. O teste de dureza foi informativo. A resistência ao atrito e ao impacto dos comprimidos estava dentro dos parâmetros, sendo assim a friabilidade foi satisfatória. Os comprimidos do hidroclorotiazida se desintegraram em um tempo maior que os do Clorana®, mas dentro do estabelecido. Ambos os medicamentos foram dissolvidos dentro do tempo preciso. No teste de doseamento, o teor obtido estava dentro das conformidades. Tendo em vista os resultados dos testes dos ensaios físico-químicos, o estudo comprovou que os medicamentos estão dentro dos parâmetros de qualidade e certificou a segurança em termos físico-químicos da utilização do medicamento genérico testado no tratamento da Hipertensão Arterial Sistêmica.Research, Society and Development2021-07-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/1683910.33448/rsd-v10i8.16839Research, Society and Development; Vol. 10 No. 8; e3810716839Research, Society and Development; Vol. 10 Núm. 8; e3810716839Research, Society and Development; v. 10 n. 8; e38107168392525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/16839/15184Copyright (c) 2021 Jéssica Aparecida Silva Trindade; Laura Virgínia Moreira Rodrigues; Samara Caroline Souza Oliveira; Ywia Danieli Valadares; Wander Valadares de Oliveira Júnior; Eduardo Nogueira Cortez; Thays Santos Mendonçahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessTrindade, Jéssica Aparecida SilvaRodrigues, Laura Virgínia MoreiraOliveira, Samara Caroline SouzaValadares, Ywia DanieliOliveira Júnior, Wander Valadares deCortez, Eduardo NogueiraMendonça, Thays Santos2021-08-21T18:46:59Zoai:ojs.pkp.sfu.ca:article/16839Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:37:17.277945Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
Parámetros de calidad fisicoquímica del fármaco genérico hidroclorotiazida en relación con el fármaco de referencia Clorana®
Parâmetros físico-químicos de qualidade do medicamento genérico hidroclorotiazida em relação ao medicamento de referência Clorana®
title Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
spellingShingle Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
Trindade, Jéssica Aparecida Silva
Drugs, Generic
Hydrochlorothiazide
Hypertension
Reference drugs.
Hidroclorotiazida
Hipertensión
Medicamentos Genéricos
Medicamentos de referencia.
Hidroclorotiazida
Hipertensão
Medicamentos Genéricos
Medicamentos de referência.
title_short Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
title_full Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
title_fullStr Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
title_full_unstemmed Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
title_sort Physicochemical quality parameters of the generic drug hydrochlorothiazide in relation to the reference drug Clorana®
author Trindade, Jéssica Aparecida Silva
author_facet Trindade, Jéssica Aparecida Silva
Rodrigues, Laura Virgínia Moreira
Oliveira, Samara Caroline Souza
Valadares, Ywia Danieli
Oliveira Júnior, Wander Valadares de
Cortez, Eduardo Nogueira
Mendonça, Thays Santos
author_role author
author2 Rodrigues, Laura Virgínia Moreira
Oliveira, Samara Caroline Souza
Valadares, Ywia Danieli
Oliveira Júnior, Wander Valadares de
Cortez, Eduardo Nogueira
Mendonça, Thays Santos
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Trindade, Jéssica Aparecida Silva
Rodrigues, Laura Virgínia Moreira
Oliveira, Samara Caroline Souza
Valadares, Ywia Danieli
Oliveira Júnior, Wander Valadares de
Cortez, Eduardo Nogueira
Mendonça, Thays Santos
dc.subject.por.fl_str_mv Drugs, Generic
Hydrochlorothiazide
Hypertension
Reference drugs.
Hidroclorotiazida
Hipertensión
Medicamentos Genéricos
Medicamentos de referencia.
Hidroclorotiazida
Hipertensão
Medicamentos Genéricos
Medicamentos de referência.
topic Drugs, Generic
Hydrochlorothiazide
Hypertension
Reference drugs.
Hidroclorotiazida
Hipertensión
Medicamentos Genéricos
Medicamentos de referencia.
Hidroclorotiazida
Hipertensão
Medicamentos Genéricos
Medicamentos de referência.
description This study aimed to compare the physical-chemical parameters of quality of the generic drug hydrochlorothiazide 25 mg in relation to the reference drug Clorana®. The following tests were performed: determination of average weight, identification, hardness, friability, disintegration, dissolution and dosing. All tests showed satisfactory results. In determining the average weight, the results obtained for both drugs showed little variation. In the identification test, the sample readings were in agreement with the standard. The hardness test was informative. The resistance to friction and impact of the tablets was within the parameters, so the friability was satisfactory. The hydrochlorothiazide tablets disintegrated in a longer time than those of Chlorana®, but within the established. Both drugs were dissolved within the precise time. In the dosing test, the content obtained was within the conformities. In view of the results of the tests of the physical-chemical tests, the study proved that the drugs are within the quality parameters and certified the safety in physical-chemical terms of the use of the generic drug tested in the treatment of Systemic Arterial Hypertension.
publishDate 2021
dc.date.none.fl_str_mv 2021-07-04
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/16839
10.33448/rsd-v10i8.16839
url https://rsdjournal.org/index.php/rsd/article/view/16839
identifier_str_mv 10.33448/rsd-v10i8.16839
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/16839/15184
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
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. 10 No. 8; e3810716839
Research, Society and Development; Vol. 10 Núm. 8; e3810716839
Research, Society and Development; v. 10 n. 8; e3810716839
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_ 1797052750930903040

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