Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

Detalhes bibliográficos
Autor(a) principal: Chorilli, Marlus [UNESP]
Data de Publicação: 2010
Outros Autores: Souza, A. A., Corrêa, F., Salgado, Hérida Regina Nunes [UNESP]
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/1296
http://hdl.handle.net/11449/72218
Resumo: With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.
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spelling Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsulaStudy of dissolution profile of the pioneer brand name, generic and similar brand name pharmaceutical products containing cephalexin in the form of capsulesCephalexinDissolution profileGeneric medicineReference medicineSimilar medicinecefalexingeneric drugcapsule endoscopedrug delivery systemdrug dosage formdrug releasedrug researchdrug solubilityin vitro studymedical literatureWith recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.Com o avanço da tecnologia e das pesquisas envolvendo liberação de fármacos, modernização de testes e maior ênfase da previsibilidade de efeitos terapêuticos por meio dos testes in vitro, os testes de dissolução e os estudos de perfis de dissolução têm ganhado cada vez mais importância. Apesar de terem sido introduzidos inicialmente como uma forma de caracterizar o perfil de liberação de fármacos pouco solúveis, atualmente os testes de dissolução fazem parte das monografias de quase todas as formas farmacêuticas sólidas orais. Este trabalho teve como objetivo estudar o perfil de dissolução (porcentagem de fármaco dissolvido versus tempo) dos medicamentos de referência, genérico e similar contendo cefalexina 500 mg na forma farmacêutica de cápsulas. Foram analisadas três especialidades farmacêuticas (referência, genérico e similar), os quais foram submetidos ao teste de dissolução e perfil de dissolução in vitro. Os resultados obtidos no teste de dissolução permitem concluir que as amostras encontraram-se de acordo com as especificações e o perfil de dissolução deste medicamento, nesta forma farmacêutica, é considerado de dissolução rápida (85% de fármaco dissolvido em 15 minutos). Portanto, existe uma grande semelhança entre as curvas obtidas, o que sugere que se trata de equivalentes farmacêuticos.Curso de Ciências Farmacêuticas Centro de Ciências da Vida Pontifícia Universidade Católica de Campinas, PUCCAMP, Campinas, SPFaculdade de Ciências da Saúde Curso de Farmácia Universidade Metodista de Piracicaba, UNIMEP, Piracicaba, SPDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas de Araraquara UNESP, Rodovia Araraquara-Jaú, km 1, CEP. 14801-902 - Araraquara SPDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas de Araraquara UNESP, Rodovia Araraquara-Jaú, km 1, CEP. 14801-902 - Araraquara SPPontifícia Universidade Católica de Campinas (PUC-CAMPINAS)Universidade Metodista de Piracicaba (UNIMEP)Universidade Estadual Paulista (Unesp)Chorilli, Marlus [UNESP]Souza, A. A.Corrêa, F.Salgado, Hérida Regina Nunes [UNESP]2014-05-27T11:25:25Z2014-05-27T11:25:25Z2010-12-13info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article69-73application/pdfhttp://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/1296Revista de Ciencias Farmaceuticas Basica e Aplicada, v. 31, n. 1, p. 69-73, 2010.1808-45322179-443Xhttp://hdl.handle.net/11449/722182-s2.0-786498734772-s2.0-78649873477.pdfScopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPporRevista de Ciências Farmacêuticas Básica e Aplicada0,131info:eu-repo/semantics/openAccess2024-06-24T13:45:50Zoai:repositorio.unesp.br:11449/72218Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T18:58:13.350049Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
Study of dissolution profile of the pioneer brand name, generic and similar brand name pharmaceutical products containing cephalexin in the form of capsules
title Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
spellingShingle Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
Chorilli, Marlus [UNESP]
Cephalexin
Dissolution profile
Generic medicine
Reference medicine
Similar medicine
cefalexin
generic drug
capsule endoscope
drug delivery system
drug dosage form
drug release
drug research
drug solubility
in vitro study
medical literature
title_short Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
title_full Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
title_fullStr Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
title_full_unstemmed Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
title_sort Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
author Chorilli, Marlus [UNESP]
author_facet Chorilli, Marlus [UNESP]
Souza, A. A.
Corrêa, F.
Salgado, Hérida Regina Nunes [UNESP]
author_role author
author2 Souza, A. A.
Corrêa, F.
Salgado, Hérida Regina Nunes [UNESP]
author2_role author
author
author
dc.contributor.none.fl_str_mv Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS)
Universidade Metodista de Piracicaba (UNIMEP)
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Chorilli, Marlus [UNESP]
Souza, A. A.
Corrêa, F.
Salgado, Hérida Regina Nunes [UNESP]
dc.subject.por.fl_str_mv Cephalexin
Dissolution profile
Generic medicine
Reference medicine
Similar medicine
cefalexin
generic drug
capsule endoscope
drug delivery system
drug dosage form
drug release
drug research
drug solubility
in vitro study
medical literature
topic Cephalexin
Dissolution profile
Generic medicine
Reference medicine
Similar medicine
cefalexin
generic drug
capsule endoscope
drug delivery system
drug dosage form
drug release
drug research
drug solubility
in vitro study
medical literature
description With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.
publishDate 2010
dc.date.none.fl_str_mv 2010-12-13
2014-05-27T11:25:25Z
2014-05-27T11:25:25Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/1296
Revista de Ciencias Farmaceuticas Basica e Aplicada, v. 31, n. 1, p. 69-73, 2010.
1808-4532
2179-443X
http://hdl.handle.net/11449/72218
2-s2.0-78649873477
2-s2.0-78649873477.pdf
url http://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/1296
http://hdl.handle.net/11449/72218
identifier_str_mv Revista de Ciencias Farmaceuticas Basica e Aplicada, v. 31, n. 1, p. 69-73, 2010.
1808-4532
2179-443X
2-s2.0-78649873477
2-s2.0-78649873477.pdf
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv Revista de Ciências Farmacêuticas Básica e Aplicada
0,131
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 69-73
application/pdf
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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