Assessment of the quality of simvastatin capsules from compounding pharmacies

Detalhes bibliográficos
Autor(a) principal: Markman, Blanca Elena Ortega
Data de Publicação: 2010
Outros Autores: Rosa, Paulo César Pires, Koschtschak, Maria Regina Walter
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Revista de Saúde Pública
Texto Completo: https://www.revistas.usp.br/rsp/article/view/32863
Resumo: OBJECTIVE: To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS: Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS: The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS: The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.
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spelling Assessment of the quality of simvastatin capsules from compounding pharmacies Evaluación de la calidad de cápsulas de sinvastatina de farmacias magistrales Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais SinvastatinanormasCápsulasquímicaComposição de MedicamentosQuímica FarmacêuticaQualidade dos MedicamentosSimvastatinanormasCápsulasquímicaComposición de MedicamentosQuímica FarmacéuticaCalidad de los MedicamentosSimvastatinstandardsCapsuleschemistryDrug CompoundingChemistryPharmaceuticalDrug Quality OBJECTIVE: To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS: Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS: The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS: The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies. OBJETIVO: Validar metodología por cromatografía líquida de alta eficiencia para determinación del tenor de sinvastatina en cápsulas manipuladas. MÉTODOS: Fueron evaluadas 18 muestras de cápsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los análisis se basaron en la Farmacopéia Brasileña y en el método de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificación, y cuantificación en cápsulas manipuladas. RESULTADOS: El peso promedio de las cápsulas variaron de 70 a 316 mg; cuatro muestras presentaron variación de peso en desacuerdo con la especificación. El tenor de sinvastatina en las cápsulas estaba de acuerdo con la especificación en 11 muestras; en seis, ese tenor varió entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinación del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvíos-patrones relativos mayores que 6%; tres farmacias atendían la especificación del ensayo. En el ensayo de disolución, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demás presentaron resultados inconclusitos. CONCLUSIONES: El método utilizado mostró buena adecuación para aplicación en control de calidad, revelando la falta de calidad de cápsulas de sinvastatina producidas por algunas farmacias de manipulación. OBJETIVO: Validar metodologia por cromatografia líquida de alta eficiência para determinação do teor de sinvastatina em cápsulas manipuladas. MÉTODOS: Foram avaliadas 18 amostras de cápsulas de sinvastatina 40 mg de farmácias magistrais de São Paulo, Guarulhos, São Bernardo do Campo e Campinas, SP, prescritas para pacientes fictícios. As análises basearam-se na Farmacopéia Brasileira e no método da cromatografia, otimizado e validado de acordo com as normas nacionais e internacionais, para os ensaios de identificação, e quantificação em cápsulas manipuladas. RESULTADOS: O peso médio das cápsulas variou de 70 mg a 316 mg; quatro amostras apresentaram variação de peso em desacordo com a especificação. O teor de sinvastatina nas cápsulas estava de acordo com a especificação em 11 amostras; em seis, esse teor variou entre 4% e 87% do valor declarado, descumprindo os requisitos de teor do princípio ativo; a determinação do teor e uniformidade de conteúdo de uma amostra não foram realizadas. No teste de uniformidade de conteúdo, 15 amostras apresentaram valores menores que 85% e com os desvios-padrões relativos maiores que 6%; três farmácias atendiam a especificação desse ensaio. No ensaio de dissolução, oito amostras apresentaram resultados insatisfatórios no primeiro estágio do ensaio e as demais apresentaram resultados inconclusivos. CONCLUSÕES: O método utilizado mostrou boa adequação para aplicação em controle de qualidade, revelando a falta de qualidade de cápsulas de sinvastatina produzidas por algumas farmácias de manipulação. Universidade de São Paulo. Faculdade de Saúde Pública2010-12-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://www.revistas.usp.br/rsp/article/view/3286310.1590/S0034-89102010000600010Revista de Saúde Pública; Vol. 44 No. 6 (2010); 1055-1062 Revista de Saúde Pública; Vol. 44 Núm. 6 (2010); 1055-1062 Revista de Saúde Pública; v. 44 n. 6 (2010); 1055-1062 1518-87870034-8910reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USPporenghttps://www.revistas.usp.br/rsp/article/view/32863/35422https://www.revistas.usp.br/rsp/article/view/32863/35423Copyright (c) 2017 Revista de Saúde Públicainfo:eu-repo/semantics/openAccessMarkman, Blanca Elena OrtegaRosa, Paulo César PiresKoschtschak, Maria Regina Walter2012-07-10T02:29:59Zoai:revistas.usp.br:article/32863Revistahttps://www.revistas.usp.br/rsp/indexONGhttps://www.revistas.usp.br/rsp/oairevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2012-07-10T02:29:59Revista de Saúde Pública - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Assessment of the quality of simvastatin capsules from compounding pharmacies
Evaluación de la calidad de cápsulas de sinvastatina de farmacias magistrales
Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais
title Assessment of the quality of simvastatin capsules from compounding pharmacies
spellingShingle Assessment of the quality of simvastatin capsules from compounding pharmacies
Markman, Blanca Elena Ortega
Sinvastatina
normas
Cápsulas
química
Composição de Medicamentos
Química Farmacêutica
Qualidade dos Medicamentos
Simvastatina
normas
Cápsulas
química
Composición de Medicamentos
Química Farmacéutica
Calidad de los Medicamentos
Simvastatin
standards
Capsules
chemistry
Drug Compounding
Chemistry
Pharmaceutical
Drug Quality
title_short Assessment of the quality of simvastatin capsules from compounding pharmacies
title_full Assessment of the quality of simvastatin capsules from compounding pharmacies
title_fullStr Assessment of the quality of simvastatin capsules from compounding pharmacies
title_full_unstemmed Assessment of the quality of simvastatin capsules from compounding pharmacies
title_sort Assessment of the quality of simvastatin capsules from compounding pharmacies
author Markman, Blanca Elena Ortega
author_facet Markman, Blanca Elena Ortega
Rosa, Paulo César Pires
Koschtschak, Maria Regina Walter
author_role author
author2 Rosa, Paulo César Pires
Koschtschak, Maria Regina Walter
author2_role author
author
dc.contributor.author.fl_str_mv Markman, Blanca Elena Ortega
Rosa, Paulo César Pires
Koschtschak, Maria Regina Walter
dc.subject.por.fl_str_mv Sinvastatina
normas
Cápsulas
química
Composição de Medicamentos
Química Farmacêutica
Qualidade dos Medicamentos
Simvastatina
normas
Cápsulas
química
Composición de Medicamentos
Química Farmacéutica
Calidad de los Medicamentos
Simvastatin
standards
Capsules
chemistry
Drug Compounding
Chemistry
Pharmaceutical
Drug Quality
topic Sinvastatina
normas
Cápsulas
química
Composição de Medicamentos
Química Farmacêutica
Qualidade dos Medicamentos
Simvastatina
normas
Cápsulas
química
Composición de Medicamentos
Química Farmacéutica
Calidad de los Medicamentos
Simvastatin
standards
Capsules
chemistry
Drug Compounding
Chemistry
Pharmaceutical
Drug Quality
description OBJECTIVE: To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS: Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS: The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS: The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.
publishDate 2010
dc.date.none.fl_str_mv 2010-12-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/rsp/article/view/32863
10.1590/S0034-89102010000600010
url https://www.revistas.usp.br/rsp/article/view/32863
identifier_str_mv 10.1590/S0034-89102010000600010
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/rsp/article/view/32863/35422
https://www.revistas.usp.br/rsp/article/view/32863/35423
dc.rights.driver.fl_str_mv Copyright (c) 2017 Revista de Saúde Pública
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2017 Revista de Saúde Pública
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Saúde Pública
dc.source.none.fl_str_mv Revista de Saúde Pública; Vol. 44 No. 6 (2010); 1055-1062
Revista de Saúde Pública; Vol. 44 Núm. 6 (2010); 1055-1062
Revista de Saúde Pública; v. 44 n. 6 (2010); 1055-1062
1518-8787
0034-8910
reponame:Revista de Saúde Pública
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Revista de Saúde Pública
collection Revista de Saúde Pública
repository.name.fl_str_mv Revista de Saúde Pública - Universidade de São Paulo (USP)
repository.mail.fl_str_mv revsp@org.usp.br||revsp1@usp.br
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