Determination of carbamazepine in pharmaceutical formulations
Autor(a) principal: | |
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Data de Publicação: | 2010 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFRN |
Texto Completo: | https://repositorio.ufrn.br/jspui/handle/123456789/25361 http://dx.doi.org/10.1590/S1984-82502010000300014 |
Resumo: | The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time. |
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Araujo, Aurigena Antunes deSolon, Lílian Grace da SilvaOliveira, Ana Isabel Maia deGuerra, Gerlane Coelho BernardoSoares, Luiz Alberto Lira2018-06-12T15:15:28Z2018-06-12T15:15:28Z2010ARAUJO, Aurigena Antunes de; et al. Determination of carbamazepine in pharmaceutical formulations. Brazilian Journal of Pharmaceutical Sciences (Impresso), v. 46, p. 509-513, 2010. Disponível em: < http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000300014> Acesso em: 13 mar. 2018.2175-9790https://repositorio.ufrn.br/jspui/handle/123456789/25361http://dx.doi.org/10.1590/S1984-82502010000300014The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time.O objetivo desse trabalho foi avaliar a qualidade de cinco formulações de carbamazepina na dosagem de 200,00 mg: medicamento referência Tegretol® (Novartis), medicamento genérico (indústria nacional), medicamento similar (indústria nacional) e cápsulas do mesmo medicamento obtidas de duas farmácias de manipulação da cidade do Natal, RN. Os ensaios realizados foram: peso médio, diâmetro, espessura, teor, dissolução, desintegração, dureza, friabilidade e umidade. Foi observado que nenhuma das amostras analisadas apresentou friabilidade superior ao limite máximo determinado pela Farmacopéia Americana (1,5%). O medicamento genérico, apesar de apresentar dureza superior em relação ao medicamento de referência, desintegrou em menor tempo, o que pode estar relacionado à crospovidona presente na formulação. As amostras analisadas atenderam às especificações da Farmacopéia Brasileira no que diz respeito à dissolução. Em geral, os resultados das amostras A, B, C, D e E foram considerados satisfatórios uma vez que atenderam as especificações farmacopéicas. Embora a apresentação similar não tenha atendido ao padrão USP no que diz respeito à dureza, esse dado não se mostrou significativo, uma vez que o tempo de desintegração foi satisfatório.porUniversidade de São Paulo, USPCarbamazepineMedicines/quality controlGeneric medicinesSimilar medicinesMedicines/magistral formulationDetermination of carbamazepine in pharmaceutical formulationsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRNinstname:Universidade Federal do Rio Grande do Norte (UFRN)instacron:UFRNTEXTDetermination of carbamazepine in pharmaceutical formulations_2010.pdf.txtDetermination of carbamazepine in pharmaceutical formulations_2010.pdf.txtExtracted texttext/plain22742https://repositorio.ufrn.br/bitstream/123456789/25361/3/Determination%20of%20carbamazepine%20in%20pharmaceutical%20formulations_2010.pdf.txt4f244859c4bfcd6eed588568e21039bfMD53THUMBNAILDetermination of carbamazepine in pharmaceutical formulations_2010.pdf.jpgDetermination of carbamazepine in pharmaceutical formulations_2010.pdf.jpgIM Thumbnailimage/jpeg7381https://repositorio.ufrn.br/bitstream/123456789/25361/4/Determination%20of%20carbamazepine%20in%20pharmaceutical%20formulations_2010.pdf.jpg155982cea03c6c0118ed2142b00fdaf8MD54ORIGINALDeterminationCarbamazepinePharmaceutical_Araujo_2010.pdfDeterminationCarbamazepinePharmaceutical_Araujo_2010.pdfapplication/pdf228529https://repositorio.ufrn.br/bitstream/123456789/25361/1/DeterminationCarbamazepinePharmaceutical_Araujo_2010.pdf73f66a9af6b667b4280bb4ec386e36aeMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://repositorio.ufrn.br/bitstream/123456789/25361/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD52123456789/253612021-11-11 17:23:15.281oai:https://repositorio.ufrn.br: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Repositório de PublicaçõesPUBhttp://repositorio.ufrn.br/oai/opendoar:2021-11-11T20:23:15Repositório Institucional da UFRN - Universidade Federal do Rio Grande do Norte (UFRN)false |
dc.title.pt_BR.fl_str_mv |
Determination of carbamazepine in pharmaceutical formulations |
title |
Determination of carbamazepine in pharmaceutical formulations |
spellingShingle |
Determination of carbamazepine in pharmaceutical formulations Araujo, Aurigena Antunes de Carbamazepine Medicines/quality control Generic medicines Similar medicines Medicines/magistral formulation |
title_short |
Determination of carbamazepine in pharmaceutical formulations |
title_full |
Determination of carbamazepine in pharmaceutical formulations |
title_fullStr |
Determination of carbamazepine in pharmaceutical formulations |
title_full_unstemmed |
Determination of carbamazepine in pharmaceutical formulations |
title_sort |
Determination of carbamazepine in pharmaceutical formulations |
author |
Araujo, Aurigena Antunes de |
author_facet |
Araujo, Aurigena Antunes de Solon, Lílian Grace da Silva Oliveira, Ana Isabel Maia de Guerra, Gerlane Coelho Bernardo Soares, Luiz Alberto Lira |
author_role |
author |
author2 |
Solon, Lílian Grace da Silva Oliveira, Ana Isabel Maia de Guerra, Gerlane Coelho Bernardo Soares, Luiz Alberto Lira |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Araujo, Aurigena Antunes de Solon, Lílian Grace da Silva Oliveira, Ana Isabel Maia de Guerra, Gerlane Coelho Bernardo Soares, Luiz Alberto Lira |
dc.subject.por.fl_str_mv |
Carbamazepine Medicines/quality control Generic medicines Similar medicines Medicines/magistral formulation |
topic |
Carbamazepine Medicines/quality control Generic medicines Similar medicines Medicines/magistral formulation |
description |
The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time. |
publishDate |
2010 |
dc.date.issued.fl_str_mv |
2010 |
dc.date.accessioned.fl_str_mv |
2018-06-12T15:15:28Z |
dc.date.available.fl_str_mv |
2018-06-12T15:15:28Z |
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.citation.fl_str_mv |
ARAUJO, Aurigena Antunes de; et al. Determination of carbamazepine in pharmaceutical formulations. Brazilian Journal of Pharmaceutical Sciences (Impresso), v. 46, p. 509-513, 2010. Disponível em: < http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000300014> Acesso em: 13 mar. 2018. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufrn.br/jspui/handle/123456789/25361 |
dc.identifier.issn.none.fl_str_mv |
2175-9790 |
dc.identifier.doi.none.fl_str_mv |
http://dx.doi.org/10.1590/S1984-82502010000300014 |
identifier_str_mv |
ARAUJO, Aurigena Antunes de; et al. Determination of carbamazepine in pharmaceutical formulations. Brazilian Journal of Pharmaceutical Sciences (Impresso), v. 46, p. 509-513, 2010. Disponível em: < http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000300014> Acesso em: 13 mar. 2018. 2175-9790 |
url |
https://repositorio.ufrn.br/jspui/handle/123456789/25361 http://dx.doi.org/10.1590/S1984-82502010000300014 |
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por |
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por |
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info:eu-repo/semantics/openAccess |
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openAccess |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo, USP |
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Universidade de São Paulo, USP |
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Universidade Federal do Rio Grande do Norte (UFRN) |
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UFRN |
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UFRN |
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