Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina

Detalhes bibliográficos
Autor(a) principal: Jesus, Mariana de Oliveira
Data de Publicação: 2020
Outros Autores: Moraes, Vitória Alves de
Tipo de documento: Trabalho de conclusão de curso
Idioma: por
Título da fonte: Repositório Institucional da UFS
Texto Completo: http://ri.ufs.br/jspui/handle/riufs/15996
Resumo: The quality control of medicines through chemical product tests is of great importance in ensuring the quality of medicines. Therefore, this study aimed to compare the quality of nimesulide tablets with β-cyclodextrin (Maxsulid®) and without β-cyclodextrin (Nisulid®) as a way to investigate the current tests that are tested during the duration of clinical tests that are used in pharmaceutical conditions that include cyclodextrins in their composition, using methods described in the Brazilian Pharmacopoeia 6th edition. Given the exposure, both drugs obtain good results in most tests of physical-chemical characterization. Only Nisulid® failed due to a tablet break in the reliability test. The dosage and dissolution tests were performed through quantitative determinations using High Performance Liquid Chromatography. As expected, the results of the dosing showed that the applied methodology was inefficient for the drug with inclusion complex (Maxsulid®). On dissolution, both drugs were approved according to the criteria used in the Brazilian Pharmacopoeia, however Maxsulid® was the only one to have its recovery dissolved in 120 minutes. Thus, it is clear the importance of implementing analytical protocols applicable to new technologies applied in the production of medicines.
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spelling Jesus, Mariana de OliveiraMoraes, Vitória Alves deMenezes, Paula dos Passos2022-07-26T14:09:40Z2022-07-26T14:09:40Z2020-03-10Jesus, Mariana de Oliveira ; Moraes, Vitória Alves de. Estudo comparativo do controle de qualidade de comprimidos de Nimesulida complexada e não complexada com β - ciclodextrina. São Cristóvão, 2020. Monografia (Graduação em Farmácia) – Departamento de Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Sergipe, São Cristóvão, SE, 2020http://ri.ufs.br/jspui/handle/riufs/15996The quality control of medicines through chemical product tests is of great importance in ensuring the quality of medicines. Therefore, this study aimed to compare the quality of nimesulide tablets with β-cyclodextrin (Maxsulid®) and without β-cyclodextrin (Nisulid®) as a way to investigate the current tests that are tested during the duration of clinical tests that are used in pharmaceutical conditions that include cyclodextrins in their composition, using methods described in the Brazilian Pharmacopoeia 6th edition. Given the exposure, both drugs obtain good results in most tests of physical-chemical characterization. Only Nisulid® failed due to a tablet break in the reliability test. The dosage and dissolution tests were performed through quantitative determinations using High Performance Liquid Chromatography. As expected, the results of the dosing showed that the applied methodology was inefficient for the drug with inclusion complex (Maxsulid®). On dissolution, both drugs were approved according to the criteria used in the Brazilian Pharmacopoeia, however Maxsulid® was the only one to have its recovery dissolved in 120 minutes. Thus, it is clear the importance of implementing analytical protocols applicable to new technologies applied in the production of medicines.O controle de qualidade de sólidos por meio de ensaios físico-químicos apresenta grande importância na garantia de qualidade de medicamentos. Diante disto, este estudo teve como objetivo comparar a qualidade de comprimidos de nimesulida com β-ciclodextrina (Maxsulid®) e sem β-ciclodextrina (Nisulid®) como forma de investigar se os testes vigentes aplicam-se às formas farmacêuticas que contenham complexos de inclusão com ciclodextrinas em sua composição, por meio de metodologias descritas na Farmacopeia Brasileira 6ª edição. Frente ao exposto, ambos os medicamentos obtiveram bons resultados na maioria dos testes de caracterização físico-química. Somente o Nisulid® apresentou falha devido à quebra de um comprimido no ensaio de friabilidade. Os testes de doseamento e dissolução foram realizados através de determinações quantitativas por meio da Cromatografia Líquida de Alta Eficiência. Como já esperado, os resultados do doseamento demonstraram que a metodologia aplicada foi ineficiente para o fármaco com complexo de inclusão (Maxsulid®). Já na dissolução, os dois medicamentos foram aprovados de acordo com os critérios estabelecidos na Farmacopeia Brasileira. Porém o Maxsulid® foi o único a obter sua totalidade dissolvida em 120 minutos. Dessa forma, fica clara a importância da implementação de protocolos analíticos adequados às novas tecnologias aplicadas na produção de medicamentos.São Cristóvão, SEporFarmáciaEnsino de farmáciaControle de qualidadeβ-ciclodextrinaNimesulidaFarmacologiaQuality controlβ-cyclodextrinNimesulideCIENCIAS DA SAUDE::FARMACIA::ANALISE E CONTROLE E MEDICAMENTOSEstudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrinaComparative study of quality control of complexed and non-complexed nimesulide tablets with β-cyclodextrininfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/bachelorThesisUniversidade Federal de SergipeDFA - Departamento de Farmácia – São Cristóvão - Presencialreponame:Repositório Institucional da UFSinstname:Universidade Federal de Sergipe (UFS)instacron:UFSinfo:eu-repo/semantics/openAccessORIGINALMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdfMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdfapplication/pdf544550https://ri.ufs.br/jspui/bitstream/riufs/15996/2/Mariana_Oliveira_Jesus_%26_Vitoria_Alves%20_Moraes.pdfa100fd9eb8be7fa8252a7aaf9d360318MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-81475https://ri.ufs.br/jspui/bitstream/riufs/15996/1/license.txt098cbbf65c2c15e1fb2e49c5d306a44cMD51TEXTMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdf.txtMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdf.txtExtracted texttext/plain40174https://ri.ufs.br/jspui/bitstream/riufs/15996/3/Mariana_Oliveira_Jesus_%26_Vitoria_Alves%20_Moraes.pdf.txt977bb7d3c3e01c8d3c2a77df938aba95MD53THUMBNAILMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdf.jpgMariana_Oliveira_Jesus_&_Vitoria_Alves _Moraes.pdf.jpgGenerated Thumbnailimage/jpeg1586https://ri.ufs.br/jspui/bitstream/riufs/15996/4/Mariana_Oliveira_Jesus_%26_Vitoria_Alves%20_Moraes.pdf.jpg7ada65b0149860fa6968a93d7bdaf194MD54riufs/159962022-07-26 11:10:40.735oai:ufs.br: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Repositório InstitucionalPUBhttps://ri.ufs.br/oai/requestrepositorio@academico.ufs.bropendoar:2022-07-26T14:10:40Repositório Institucional da UFS - Universidade Federal de Sergipe (UFS)false
dc.title.pt_BR.fl_str_mv Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
dc.title.alternative.eng.fl_str_mv Comparative study of quality control of complexed and non-complexed nimesulide tablets with β-cyclodextrin
title Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
spellingShingle Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
Jesus, Mariana de Oliveira
Farmácia
Ensino de farmácia
Controle de qualidade
β-ciclodextrina
Nimesulida
Farmacologia
Quality control
β-cyclodextrin
Nimesulide
CIENCIAS DA SAUDE::FARMACIA::ANALISE E CONTROLE E MEDICAMENTOS
title_short Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
title_full Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
title_fullStr Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
title_full_unstemmed Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
title_sort Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina
author Jesus, Mariana de Oliveira
author_facet Jesus, Mariana de Oliveira
Moraes, Vitória Alves de
author_role author
author2 Moraes, Vitória Alves de
author2_role author
dc.contributor.author.fl_str_mv Jesus, Mariana de Oliveira
Moraes, Vitória Alves de
dc.contributor.advisor1.fl_str_mv Menezes, Paula dos Passos
contributor_str_mv Menezes, Paula dos Passos
dc.subject.por.fl_str_mv Farmácia
Ensino de farmácia
Controle de qualidade
β-ciclodextrina
Nimesulida
Farmacologia
topic Farmácia
Ensino de farmácia
Controle de qualidade
β-ciclodextrina
Nimesulida
Farmacologia
Quality control
β-cyclodextrin
Nimesulide
CIENCIAS DA SAUDE::FARMACIA::ANALISE E CONTROLE E MEDICAMENTOS
dc.subject.eng.fl_str_mv Quality control
β-cyclodextrin
Nimesulide
dc.subject.cnpq.fl_str_mv CIENCIAS DA SAUDE::FARMACIA::ANALISE E CONTROLE E MEDICAMENTOS
description The quality control of medicines through chemical product tests is of great importance in ensuring the quality of medicines. Therefore, this study aimed to compare the quality of nimesulide tablets with β-cyclodextrin (Maxsulid®) and without β-cyclodextrin (Nisulid®) as a way to investigate the current tests that are tested during the duration of clinical tests that are used in pharmaceutical conditions that include cyclodextrins in their composition, using methods described in the Brazilian Pharmacopoeia 6th edition. Given the exposure, both drugs obtain good results in most tests of physical-chemical characterization. Only Nisulid® failed due to a tablet break in the reliability test. The dosage and dissolution tests were performed through quantitative determinations using High Performance Liquid Chromatography. As expected, the results of the dosing showed that the applied methodology was inefficient for the drug with inclusion complex (Maxsulid®). On dissolution, both drugs were approved according to the criteria used in the Brazilian Pharmacopoeia, however Maxsulid® was the only one to have its recovery dissolved in 120 minutes. Thus, it is clear the importance of implementing analytical protocols applicable to new technologies applied in the production of medicines.
publishDate 2020
dc.date.issued.fl_str_mv 2020-03-10
dc.date.accessioned.fl_str_mv 2022-07-26T14:09:40Z
dc.date.available.fl_str_mv 2022-07-26T14:09:40Z
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dc.identifier.citation.fl_str_mv Jesus, Mariana de Oliveira ; Moraes, Vitória Alves de. Estudo comparativo do controle de qualidade de comprimidos de Nimesulida complexada e não complexada com β - ciclodextrina. São Cristóvão, 2020. Monografia (Graduação em Farmácia) – Departamento de Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Sergipe, São Cristóvão, SE, 2020
dc.identifier.uri.fl_str_mv http://ri.ufs.br/jspui/handle/riufs/15996
identifier_str_mv Jesus, Mariana de Oliveira ; Moraes, Vitória Alves de. Estudo comparativo do controle de qualidade de comprimidos de Nimesulida complexada e não complexada com β - ciclodextrina. São Cristóvão, 2020. Monografia (Graduação em Farmácia) – Departamento de Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Sergipe, São Cristóvão, SE, 2020
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dc.publisher.department.fl_str_mv DFA - Departamento de Farmácia – São Cristóvão - Presencial
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