Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM
Autor(a) principal: | |
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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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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 |
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Universidade Federal do Amazonas (UFAM) |
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UFAM |
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UFAM |
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Repositório Institucional da UFAM |
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Repositório Institucional da UFAM |
repository.name.fl_str_mv |
Repositório Institucional da UFAM - Universidade Federal do Amazonas (UFAM) |
repository.mail.fl_str_mv |
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