Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via

Detalhes bibliográficos
Autor(a) principal: Braga, Beatriz Pavão
Data de Publicação: 2020
Outros Autores: Bono, Eduarda Camila, Chiari-Andréo, Bruna Galdorfini, Formariz, Thalita Pedroni
Tipo de documento: Artigo
Idioma: por
Título da fonte: Revista Brasileira Multidisciplinar
Texto Completo: http://revistarebram.com/index.php/revistauniara/article/view/768
Resumo: Enteric tablets are preparations developed with a polymeric coating that is insoluble in acid media in order to protect unstable drugs of the action of gastric acid. Thus, it’s relevant the development of gastro-resistant coated tablets containing ibuprofen since this drug is able to cause gastric irritability due to the decrease of the protective prostaglandins production related to the mucus synthesis. Therefore this research aimed to develop enteric coated tablets containing ibuprofen by dry and wet vias and to perform the quality control tests, for example, average weight, disintegration, hardness and friability in order to verify if the tablets developed complies standards established by Brazilian Pharmacopoeia sixth edition (2019). The methodology used was the compression method for obtaining ibuprofen tablets by dry via and wet via with cellulose acetate phthalate coating.  After coating, quality control tests were performed: average weight, hardness, friability and desintegration. The results showed the importance of the study of preformulation and formulation in the development of ibuprofen tablets as well as the importance of the study of the preformulation and the formulation of the enteric coating solution and the study of its production to guarantee the quality of the final product, in this case, gastro-resistant tablets. The parameters evaluated in the quality control assays indicated that the gastro-resistant ibuprofen tablets obtained by dry via are in accordance with the pharmacopeia specifications. On the other hand, the gastro-resistant tablets of ibuprofen obtained by wet via showed unsatisfactory results in terms of average weight which suggests an error in filling the matrix and adjusting of the lower and upper punctures. Thereby, the ibuprofen tablets obtained by dry via showed better quality which means that this method of preparation of gastrorresistant tablets is safer for the population.
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spelling Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet viaDesenvolvimento e avaliação da qualidade de comprimidos gastrorresistentes de ibuprofeno obtidos por via seca e via úmidacomprimidos gastrorresistentesibuprofenocontrole de qualidadegranulação de via seca e via úmida.Enteric tablets are preparations developed with a polymeric coating that is insoluble in acid media in order to protect unstable drugs of the action of gastric acid. Thus, it’s relevant the development of gastro-resistant coated tablets containing ibuprofen since this drug is able to cause gastric irritability due to the decrease of the protective prostaglandins production related to the mucus synthesis. Therefore this research aimed to develop enteric coated tablets containing ibuprofen by dry and wet vias and to perform the quality control tests, for example, average weight, disintegration, hardness and friability in order to verify if the tablets developed complies standards established by Brazilian Pharmacopoeia sixth edition (2019). The methodology used was the compression method for obtaining ibuprofen tablets by dry via and wet via with cellulose acetate phthalate coating.  After coating, quality control tests were performed: average weight, hardness, friability and desintegration. The results showed the importance of the study of preformulation and formulation in the development of ibuprofen tablets as well as the importance of the study of the preformulation and the formulation of the enteric coating solution and the study of its production to guarantee the quality of the final product, in this case, gastro-resistant tablets. The parameters evaluated in the quality control assays indicated that the gastro-resistant ibuprofen tablets obtained by dry via are in accordance with the pharmacopeia specifications. On the other hand, the gastro-resistant tablets of ibuprofen obtained by wet via showed unsatisfactory results in terms of average weight which suggests an error in filling the matrix and adjusting of the lower and upper punctures. Thereby, the ibuprofen tablets obtained by dry via showed better quality which means that this method of preparation of gastrorresistant tablets is safer for the population.Os comprimidos entéricos são preparações desenvolvidas com um revestimento polimérico insolúvel em meio ácido com objetivo de proteger fármacos instáveis sob ação do suco gástrico. Neste sentido torna-se relevante o desenvolvimento de comprimidos revestidos gastrorresistente contendo ibuprofeno uma vez que o mesmo apresenta irritabilidade gástrica, pela diminuição da produção da síntese de prostaglandinas mucoprotetoras. Assim, o presente artigo teve como objetivo desenvolver comprimidos de revestimento entérico contendo ibuprofeno por via seca e via úmida, bem como realizar os testes de controle de qualidade, como por exemplo, peso médio, desintegração, dureza e friabilidade tendo como finalidade verificar se comprimido desenvolvido está em conformidade com os parâmetros estabelecidos na Farmacopeia Brasileira 6ª edição (2019). A metodologia utilizada foi o método de compressão para obtenção dos comprimidos de ibuprofeno obtidos por via seca e por via úmida seguido de revestimento com acetoftalato de celulose. Após o revestimento realizaram-se os testes de controle de qualidade os quais foram: peso médio, dureza, friabilidade e desintegração. Os resultados mostraram a importância quanto ao estudo de pré-formulação e da formulação no desenvolvimento de comprimidos de ibuprofeno, bem como a importância do estudo de pré-formulação e da formulação da solução de revestimento entérico e o estudo de sua produção para garantir a qualidade do produto final, no caso os comprimidos gastrorresistentes. Os parâmetros avaliados de controle de qualidade indicaram que os comprimidos gastrorresistentes de ibuprofeno obtidos por via seca apresentaram-se conforme as especificações farmacopeias. Por outro lado, os comprimidos gastrorresistentes de ibuprofeno obtidos por via úmida comprovaram resultados não satisfatórios quanto ao peso médio sugerindo erro no preenchimento da matriz e regulagem das punções superior e inferior. Neste sentido, os comprimidos de ibuprofeno obtidos por via seca, apresentaram melhor qualidade sendo, portanto, este método de obtenção mais seguros para a população.  Revista Brasileira Multidisciplinar - ReBraM2020-05-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://revistarebram.com/index.php/revistauniara/article/view/76810.25061/2527-2675/ReBraM/2020.v23i2.768Revista Brasileira Multidisciplinar - ReBraM; v. 23 n. 2 (2020): Maio-Agosto; 124-1352527-26751415-3580reponame:Revista Brasileira Multidisciplinarinstname:Universidade de Araraquara (UNIARA)instacron:UNIARAporhttp://revistarebram.com/index.php/revistauniara/article/view/768/594Copyright (c) 2020 Revista Brasileira Multidisciplinarinfo:eu-repo/semantics/openAccessBraga, Beatriz PavãoBono, Eduarda CamilaChiari-Andréo, Bruna Galdorfini Formariz, Thalita Pedroni2020-10-05T03:34:04Zoai:ojs.revistarebram.com:article/768Revistahttp://revistarebram.com/index.php/revistauniaraPRIhttps://revistarebram.com/index.php/revistauniara/oairevistauniara@uniara.com||2527-26752527-2675opendoar:2020-10-05T03:34:04Revista Brasileira Multidisciplinar - Universidade de Araraquara (UNIARA)false
dc.title.none.fl_str_mv Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
Desenvolvimento e avaliação da qualidade de comprimidos gastrorresistentes de ibuprofeno obtidos por via seca e via úmida
title Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
spellingShingle Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
Braga, Beatriz Pavão
comprimidos gastrorresistentes
ibuprofeno
controle de qualidade
granulação de via seca e via úmida.
title_short Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
title_full Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
title_fullStr Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
title_full_unstemmed Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
title_sort Development and evaluation of the quality of gastro-resistant tablets of ibuprofen obtained by dry and wet via
author Braga, Beatriz Pavão
author_facet Braga, Beatriz Pavão
Bono, Eduarda Camila
Chiari-Andréo, Bruna Galdorfini
Formariz, Thalita Pedroni
author_role author
author2 Bono, Eduarda Camila
Chiari-Andréo, Bruna Galdorfini
Formariz, Thalita Pedroni
author2_role author
author
author
dc.contributor.author.fl_str_mv Braga, Beatriz Pavão
Bono, Eduarda Camila
Chiari-Andréo, Bruna Galdorfini
Formariz, Thalita Pedroni
dc.subject.por.fl_str_mv comprimidos gastrorresistentes
ibuprofeno
controle de qualidade
granulação de via seca e via úmida.
topic comprimidos gastrorresistentes
ibuprofeno
controle de qualidade
granulação de via seca e via úmida.
description Enteric tablets are preparations developed with a polymeric coating that is insoluble in acid media in order to protect unstable drugs of the action of gastric acid. Thus, it’s relevant the development of gastro-resistant coated tablets containing ibuprofen since this drug is able to cause gastric irritability due to the decrease of the protective prostaglandins production related to the mucus synthesis. Therefore this research aimed to develop enteric coated tablets containing ibuprofen by dry and wet vias and to perform the quality control tests, for example, average weight, disintegration, hardness and friability in order to verify if the tablets developed complies standards established by Brazilian Pharmacopoeia sixth edition (2019). The methodology used was the compression method for obtaining ibuprofen tablets by dry via and wet via with cellulose acetate phthalate coating.  After coating, quality control tests were performed: average weight, hardness, friability and desintegration. The results showed the importance of the study of preformulation and formulation in the development of ibuprofen tablets as well as the importance of the study of the preformulation and the formulation of the enteric coating solution and the study of its production to guarantee the quality of the final product, in this case, gastro-resistant tablets. The parameters evaluated in the quality control assays indicated that the gastro-resistant ibuprofen tablets obtained by dry via are in accordance with the pharmacopeia specifications. On the other hand, the gastro-resistant tablets of ibuprofen obtained by wet via showed unsatisfactory results in terms of average weight which suggests an error in filling the matrix and adjusting of the lower and upper punctures. Thereby, the ibuprofen tablets obtained by dry via showed better quality which means that this method of preparation of gastrorresistant tablets is safer for the population.
publishDate 2020
dc.date.none.fl_str_mv 2020-05-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
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dc.identifier.uri.fl_str_mv http://revistarebram.com/index.php/revistauniara/article/view/768
10.25061/2527-2675/ReBraM/2020.v23i2.768
url http://revistarebram.com/index.php/revistauniara/article/view/768
identifier_str_mv 10.25061/2527-2675/ReBraM/2020.v23i2.768
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv http://revistarebram.com/index.php/revistauniara/article/view/768/594
dc.rights.driver.fl_str_mv Copyright (c) 2020 Revista Brasileira Multidisciplinar
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2020 Revista Brasileira Multidisciplinar
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Revista Brasileira Multidisciplinar - ReBraM
publisher.none.fl_str_mv Revista Brasileira Multidisciplinar - ReBraM
dc.source.none.fl_str_mv Revista Brasileira Multidisciplinar - ReBraM; v. 23 n. 2 (2020): Maio-Agosto; 124-135
2527-2675
1415-3580
reponame:Revista Brasileira Multidisciplinar
instname:Universidade de Araraquara (UNIARA)
instacron:UNIARA
instname_str Universidade de Araraquara (UNIARA)
instacron_str UNIARA
institution UNIARA
reponame_str Revista Brasileira Multidisciplinar
collection Revista Brasileira Multidisciplinar
repository.name.fl_str_mv Revista Brasileira Multidisciplinar - Universidade de Araraquara (UNIARA)
repository.mail.fl_str_mv revistauniara@uniara.com||
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