Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2018 |
| Outros Autores: | , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | por eng |
| Título da fonte: | Vigilância Sanitária em Debate |
| DOI: | 10.22239/2317-269X.01134 |
| Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134 |
| Resumo: | Introduction: Incorrect doses of the active ingredient in compounding formulations make up common errors in the manipulation, which can cause harm to the patient’s health, reflecting the possible absence of Good Handling Practices (GHP). Objective: To report quality deviations in the medicines acetic acid solution, ketoconazole syrup and T4 capsules. Method: Identification by chemical reactions and by HPLC, content by titration and HPLC, pH by potentiometry. Results: Positive identification for acetic acid with 98.20% content compatible with glacial acetic acid, in disagreement with the prescription of 5% solution. The ketoconazole content of 16.20 mg/mL found in the syrup corresponds to 81.00% of the declared, the minimum specification is 90.00%; pH 8.0; positive identification for anionic surfactant component in the syrup. The results found were: 25 μg T4 capsules were 177.70 μg and for the 200 μg capsules it was 174.44 μg, corresponding to 710.96% and 87.22% of the declared content, respectively, in disagreement with specification 90.00% and 110.00%. Conclusions: The study illustrated the detection of quality deviations in manipulated drugs from different pharmacies, due to pharmacotechnical misconceptions, lack of quality control and lack of GHP implementation. Frequent inspection prevents health risks to the population. |
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Vigilância Sanitária em Debate |
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Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsulesDetecção de desvios de qualidade nos medicamentos manipulados: solução de ácido acético, xarope de cetoconazol e cápsulas de hormônio tireoidiano T4Medicamentos ManipuladosRisco SanitárioDesvios da QualidadeSaúde PúblicaCompounding FormulationsHealth SurveillancePharmaceutical AssistancePublic HealthIntroduction: Incorrect doses of the active ingredient in compounding formulations make up common errors in the manipulation, which can cause harm to the patient’s health, reflecting the possible absence of Good Handling Practices (GHP). Objective: To report quality deviations in the medicines acetic acid solution, ketoconazole syrup and T4 capsules. Method: Identification by chemical reactions and by HPLC, content by titration and HPLC, pH by potentiometry. Results: Positive identification for acetic acid with 98.20% content compatible with glacial acetic acid, in disagreement with the prescription of 5% solution. The ketoconazole content of 16.20 mg/mL found in the syrup corresponds to 81.00% of the declared, the minimum specification is 90.00%; pH 8.0; positive identification for anionic surfactant component in the syrup. The results found were: 25 μg T4 capsules were 177.70 μg and for the 200 μg capsules it was 174.44 μg, corresponding to 710.96% and 87.22% of the declared content, respectively, in disagreement with specification 90.00% and 110.00%. Conclusions: The study illustrated the detection of quality deviations in manipulated drugs from different pharmacies, due to pharmacotechnical misconceptions, lack of quality control and lack of GHP implementation. Frequent inspection prevents health risks to the population.Introdução: Doses incorretas do ativo nas preparações magistrais configuram erros comuns na manipulação, podendo ocasionar agravos à saúde do paciente, refletindo possível ausência das Boas Práticas de Manipulação (BPM). Objetivo: Relatar desvios de qualidade nos medicamentos solução de ácido acético, xarope de cetoconazol e cápsulas de T4. Método: Identificação por reações químicas e por CLAE, teor por titulação e CLAE, pH por potenciometria. Resultados: Identificação positiva, para ácido acético com teor de 98,20% compatível com ácido acético glacial, em desacordo com a prescrição de solução a 5%. O teor de cetoconazol de 16,20 mg/mL encontrado no xarope corresponde a 81,00% do declarado, com especificação mínima de 90,00%; pH 8,0; identificação positiva para tensoativo aniônico componente saponáceo, no xarope. Os resultados encontrados: cápsulas de T4 de 25 μg foi de 177,70 μg e as de 200 μg foi de 174,44 μg, correspondendo a 710,96% e 87,22% do teor declarado, respectivamente, em desacordo com a especificação de 90,00% a 110,00%. Conclusões: O trabalho ilustrou a detecção de desvios de qualidade em medicamentos manipulados de diferentes farmácias, decorrentes de erros farmacotécnicos, ausência de controle de qualidade e falta de implementação das BPM. A frequente fiscalização previne riscos sanitários à população.Instituto Nacional de Controle de Qualidade em Saúde2018-08-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Editor de seção"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/113410.22239/2317-269X.01134Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 3 (2018): Agosto; 22-27Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 3 (2018): Agosto; 22-27Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 3 (2018): Agosto; 22-272317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (Fiocruz)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134/491https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134/1003Copyright (c) 2018 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessFarias, Fernanda FernandesYano, Helena MiyocoYudice, Eliana Della ColettaGuilherme, Marcos PauloMartins, Valéria Adriana PereiraTrujillo, Luz MarinaSanta Bárbara, Maria CristinaMarkman, Blanca Elena Ortega2021-09-30T18:56:30Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1134Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2021-09-30T18:56:30Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (Fiocruz)false |
| dc.title.none.fl_str_mv |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules Detecção de desvios de qualidade nos medicamentos manipulados: solução de ácido acético, xarope de cetoconazol e cápsulas de hormônio tireoidiano T4 |
| title |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| spellingShingle |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules Farias, Fernanda Fernandes Medicamentos Manipulados Risco Sanitário Desvios da Qualidade Saúde Pública Compounding Formulations Health Surveillance Pharmaceutical Assistance Public Health Farias, Fernanda Fernandes Medicamentos Manipulados Risco Sanitário Desvios da Qualidade Saúde Pública Compounding Formulations Health Surveillance Pharmaceutical Assistance Public Health |
| title_short |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| title_full |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| title_fullStr |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| title_full_unstemmed |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| title_sort |
Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules |
| author |
Farias, Fernanda Fernandes |
| author_facet |
Farias, Fernanda Fernandes Farias, Fernanda Fernandes Yano, Helena Miyoco Yudice, Eliana Della Coletta Guilherme, Marcos Paulo Martins, Valéria Adriana Pereira Trujillo, Luz Marina Santa Bárbara, Maria Cristina Markman, Blanca Elena Ortega Yano, Helena Miyoco Yudice, Eliana Della Coletta Guilherme, Marcos Paulo Martins, Valéria Adriana Pereira Trujillo, Luz Marina Santa Bárbara, Maria Cristina Markman, Blanca Elena Ortega |
| author_role |
author |
| author2 |
Yano, Helena Miyoco Yudice, Eliana Della Coletta Guilherme, Marcos Paulo Martins, Valéria Adriana Pereira Trujillo, Luz Marina Santa Bárbara, Maria Cristina Markman, Blanca Elena Ortega |
| author2_role |
author author author author author author author |
| dc.contributor.author.fl_str_mv |
Farias, Fernanda Fernandes Yano, Helena Miyoco Yudice, Eliana Della Coletta Guilherme, Marcos Paulo Martins, Valéria Adriana Pereira Trujillo, Luz Marina Santa Bárbara, Maria Cristina Markman, Blanca Elena Ortega |
| dc.subject.por.fl_str_mv |
Medicamentos Manipulados Risco Sanitário Desvios da Qualidade Saúde Pública Compounding Formulations Health Surveillance Pharmaceutical Assistance Public Health |
| topic |
Medicamentos Manipulados Risco Sanitário Desvios da Qualidade Saúde Pública Compounding Formulations Health Surveillance Pharmaceutical Assistance Public Health |
| description |
Introduction: Incorrect doses of the active ingredient in compounding formulations make up common errors in the manipulation, which can cause harm to the patient’s health, reflecting the possible absence of Good Handling Practices (GHP). Objective: To report quality deviations in the medicines acetic acid solution, ketoconazole syrup and T4 capsules. Method: Identification by chemical reactions and by HPLC, content by titration and HPLC, pH by potentiometry. Results: Positive identification for acetic acid with 98.20% content compatible with glacial acetic acid, in disagreement with the prescription of 5% solution. The ketoconazole content of 16.20 mg/mL found in the syrup corresponds to 81.00% of the declared, the minimum specification is 90.00%; pH 8.0; positive identification for anionic surfactant component in the syrup. The results found were: 25 μg T4 capsules were 177.70 μg and for the 200 μg capsules it was 174.44 μg, corresponding to 710.96% and 87.22% of the declared content, respectively, in disagreement with specification 90.00% and 110.00%. Conclusions: The study illustrated the detection of quality deviations in manipulated drugs from different pharmacies, due to pharmacotechnical misconceptions, lack of quality control and lack of GHP implementation. Frequent inspection prevents health risks to the population. |
| publishDate |
2018 |
| dc.date.none.fl_str_mv |
2018-08-31 |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Editor de seção" |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134 10.22239/2317-269X.01134 |
| url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134 |
| identifier_str_mv |
10.22239/2317-269X.01134 |
| dc.language.iso.fl_str_mv |
por eng |
| language |
por eng |
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https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134/491 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1134/1003 |
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https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
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https://creativecommons.org/licenses/by-nc-nd/4.0 |
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openAccess |
| dc.format.none.fl_str_mv |
application/pdf application/pdf |
| dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
| publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
| dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 3 (2018): Agosto; 22-27 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 3 (2018): Agosto; 22-27 Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 3 (2018): Agosto; 22-27 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (Fiocruz) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (Fiocruz) |
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FIOCRUZ |
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FIOCRUZ |
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Vigilância Sanitária em Debate |
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Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (Fiocruz) |
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incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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1822182070929063936 |
| dc.identifier.doi.none.fl_str_mv |
10.22239/2317-269X.01134 |
