Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM

Detalhes bibliográficos
Autor(a) principal: Silva, Suelaine Gil da
Data de Publicação: 2024
Tipo de documento: Trabalho de conclusão de curso
Idioma: por
Título da fonte: Repositório Institucional da UFAM
Texto Completo: http://riu.ufam.edu.br/handle/prefix/7535
Resumo: Amitriptyline hydrochloride is a gold standard tricyclic antidepressant (TCA), characterized by the presence of a tertiary amine and commercially available in 10 mg, 25 mg and 75 mg coated tablets. The quality of a tablet is given by a set of actions that define the attributes necessary for efficacy. The aim of this study was to evaluate the physicochemical quality of generic amitriptyline hydrochloride tablets by comparing 3 brands available on the market in order to make inferences about the quality and efficacy of generics. Experimental research was carried out in the laboratory using analyses of average weight, hardness, disintegration, dosage and dissolution. In terms of average weight, the limits of variation for brands A, B and C were 2.05%, 2.19% and 1.85%. In the hardness test, the 3 brands of generic tablets showed differences in values, the average hardness of brand A, B and C was 4.04 kgf, 5.25 kgf and 7.32 kgf respectively. The 3 brands disintegrated in less than 15 minutes, in the dosage test the contents were 98.6%, 100.2% and 109.4% and in the dissolution test values above 80% of the active substance dissolved in the medium were obtained for all 3 brands. It was concluded that the 3 brands analyzed passed the test specifications of the Brazilian Pharmacopoeia 6th edition, thus ensuring the quality and reliability of the tablets.
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spelling Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AMEvaluation of the quality of generic amitriptyline hydrochloride 25 mg drugs sold in the city of Itacoatiara - AmAmitriptilinaMedicamentos GenéricosAntidepressivo tricíclicoControle de QualidadeCIENCIAS DA SAUDE..Amitriptyline hydrochloride is a gold standard tricyclic antidepressant (TCA), characterized by the presence of a tertiary amine and commercially available in 10 mg, 25 mg and 75 mg coated tablets. The quality of a tablet is given by a set of actions that define the attributes necessary for efficacy. The aim of this study was to evaluate the physicochemical quality of generic amitriptyline hydrochloride tablets by comparing 3 brands available on the market in order to make inferences about the quality and efficacy of generics. Experimental research was carried out in the laboratory using analyses of average weight, hardness, disintegration, dosage and dissolution. In terms of average weight, the limits of variation for brands A, B and C were 2.05%, 2.19% and 1.85%. In the hardness test, the 3 brands of generic tablets showed differences in values, the average hardness of brand A, B and C was 4.04 kgf, 5.25 kgf and 7.32 kgf respectively. The 3 brands disintegrated in less than 15 minutes, in the dosage test the contents were 98.6%, 100.2% and 109.4% and in the dissolution test values above 80% of the active substance dissolved in the medium were obtained for all 3 brands. It was concluded that the 3 brands analyzed passed the test specifications of the Brazilian Pharmacopoeia 6th edition, thus ensuring the quality and reliability of the tablets.O Cloridrato de Amitriptilina é um antidepressivo tricíclico (ADT) considerado padrão ouro, caracterizado pela presença de uma amina terciária e comercialmente apresenta-se em comprimidos revestidos de 10 mg, 25 mg e 75 mg. A qualidade de um comprimido é dada por um conjunto de ações que definem os atributos necessários para que haja eficácia. Este trabalho teve como objetivo avaliar a qualidade físico-química de comprimidos genéricos de cloridrato de amitriptilina comparando 3 marcas disponíveis no mercado de modo a inferir sobre qualidade e eficácia dos genéricos, utilizou-se da pesquisa experimental em laboratório por meio de análises de peso médio, dureza, desintegração, doseamento e dissolução. Quanto ao peso médio, o limite de variação para a marca A, B e C foram de 2,05%, 2,19% e 1,85%. No ensaio de dureza, as 3 marcas de comprimidos genéricos apresentaram diferenças nos valores, a dureza média da marca A, B e C foi de 4,04 kgf, 5,25 kgf e 7,32 kgf respectivamente. As 3 marcas desintegraram se em tempo inferior a 15 minutos, no ensaio de doseamento, os teores foram de 98,6%, 100,2% e 109,4% e no ensaio de dissolução obteve-se valores acima de 80% de substância ativa dissolvida no meio para as 3 marcas. Concluiu-se que as 3 marcas analisadas foram aprovadas pelas especificações dos testes da Farmacopeia Brasileira 6ª edição, assim, assegurando a qualidade e confiabilidade dos comprimidos genéricos.1NãoBrasilICET - Instituto de Ciências Exatas e Tecnologia (Itacoatiara)Itacoatiara (AM)Farmácia - Bacharelado - ItacoatiaraOliveira, Stéfani Ferreira dehttp://lattes.cnpq.br/6636298981639710Holanda, Keyla Emanuelle Ramos deCosta, Flávio Nogueira daSilva, Suelaine Gil da2024-08-15T00:19:33Z2024-08-15T00:19:33Z2024-07-25info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/bachelorThesishttp://riu.ufam.edu.br/handle/prefix/7535porhttps://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFAMinstname:Universidade Federal do Amazonas (UFAM)instacron:UFAM2024-08-15T00:20:53Zoai:localhost:prefix/7535Repositório InstitucionalPUBhttp://riu.ufam.edu.br/oai/requestopendoar:2024-08-15T00:20:53Repositório Institucional da UFAM - Universidade Federal do Amazonas (UFAM)false
dc.title.none.fl_str_mv Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
Evaluation of the quality of generic amitriptyline hydrochloride 25 mg drugs sold in the city of Itacoatiara - Am
title Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
spellingShingle Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
Silva, Suelaine Gil da
Amitriptilina
Medicamentos Genéricos
Antidepressivo tricíclico
Controle de Qualidade
CIENCIAS DA SAUDE
.
.
title_short Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
title_full Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
title_fullStr Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
title_full_unstemmed Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
title_sort Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
author Silva, Suelaine Gil da
author_facet Silva, Suelaine Gil da
author_role author
dc.contributor.none.fl_str_mv Oliveira, Stéfani Ferreira de
http://lattes.cnpq.br/6636298981639710
Holanda, Keyla Emanuelle Ramos de
Costa, Flávio Nogueira da
dc.contributor.author.fl_str_mv Silva, Suelaine Gil da
dc.subject.por.fl_str_mv Amitriptilina
Medicamentos Genéricos
Antidepressivo tricíclico
Controle de Qualidade
CIENCIAS DA SAUDE
.
.
topic Amitriptilina
Medicamentos Genéricos
Antidepressivo tricíclico
Controle de Qualidade
CIENCIAS DA SAUDE
.
.
description Amitriptyline hydrochloride is a gold standard tricyclic antidepressant (TCA), characterized by the presence of a tertiary amine and commercially available in 10 mg, 25 mg and 75 mg coated tablets. The quality of a tablet is given by a set of actions that define the attributes necessary for efficacy. The aim of this study was to evaluate the physicochemical quality of generic amitriptyline hydrochloride tablets by comparing 3 brands available on the market in order to make inferences about the quality and efficacy of generics. Experimental research was carried out in the laboratory using analyses of average weight, hardness, disintegration, dosage and dissolution. In terms of average weight, the limits of variation for brands A, B and C were 2.05%, 2.19% and 1.85%. In the hardness test, the 3 brands of generic tablets showed differences in values, the average hardness of brand A, B and C was 4.04 kgf, 5.25 kgf and 7.32 kgf respectively. The 3 brands disintegrated in less than 15 minutes, in the dosage test the contents were 98.6%, 100.2% and 109.4% and in the dissolution test values above 80% of the active substance dissolved in the medium were obtained for all 3 brands. It was concluded that the 3 brands analyzed passed the test specifications of the Brazilian Pharmacopoeia 6th edition, thus ensuring the quality and reliability of the tablets.
publishDate 2024
dc.date.none.fl_str_mv 2024-08-15T00:19:33Z
2024-08-15T00:19:33Z
2024-07-25
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/bachelorThesis
format bachelorThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://riu.ufam.edu.br/handle/prefix/7535
url http://riu.ufam.edu.br/handle/prefix/7535
dc.language.iso.fl_str_mv por
language por
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Brasil
ICET - Instituto de Ciências Exatas e Tecnologia (Itacoatiara)
Itacoatiara (AM)
Farmácia - Bacharelado - Itacoatiara
publisher.none.fl_str_mv Brasil
ICET - Instituto de Ciências Exatas e Tecnologia (Itacoatiara)
Itacoatiara (AM)
Farmácia - Bacharelado - Itacoatiara
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFAM
instname:Universidade Federal do Amazonas (UFAM)
instacron:UFAM
instname_str Universidade Federal do Amazonas (UFAM)
instacron_str UFAM
institution UFAM
reponame_str Repositório Institucional da UFAM
collection Repositório Institucional da UFAM
repository.name.fl_str_mv Repositório Institucional da UFAM - Universidade Federal do Amazonas (UFAM)
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