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Evaluating the discriminatory power of a dissolution assay for rosuvastatin calcium capsules: Solid-state properties and dissolution media
Ângelo, Marilene Lopes; Ruela, André Luís Morais; Ferreira, Anna Clara Marques; Ramos, Marcus Vinicus de Faria; Montanari, Cristina Martiniano; Silva, Lucélia Magalhães da; Araújo, Magali Benjamim de.
Afiliação
  • Ângelo, Marilene Lopes; Federal University of Alfenas. Faculty of Pharmaceutical Sciences. Department of Pharmacy. Alfenas. BR
  • Ruela, André Luís Morais; Federal University of Ouro Preto. School of Pharmacy. Ouro Preto. BR
  • Ferreira, Anna Clara Marques; Federal University of Alfenas. Faculty of Pharmaceutical Sciences. Department of Pharmacy. Alfenas. BR
  • Ramos, Marcus Vinicus de Faria; Federal University of Alfenas. Faculty of Pharmaceutical Sciences. Department of Pharmacy. Alfenas. BR
  • Montanari, Cristina Martiniano; University of São Paulo. Faculty of Pharmaceutical Sciences. Department of Clinical Analysis, Toxicology and Food Science. Ribeirão Preto. BR
  • Silva, Lucélia Magalhães da; Federal Institute of Paraná. Palmas. BR
  • Araújo, Magali Benjamim de; Federal University of Alfenas. Faculty of Pharmaceutical Sciences. Department of Pharmacy. Alfenas. BR
Braz. J. Pharm. Sci. (Online) ; 55: e17520, 2019. tab, graf
Article em En | LILACS | ID: biblio-1039059
Biblioteca responsável: BR40.1
Localização: BR40.1
ABSTRACT
We propose to evaluate the dissolution properties of rosuvastatin calcium (ROSC) capsules in different media to characterize the discriminatory power of the assay method. Dissolution assays were performed in media with different pH, and including the surfactant sodium dodecyl sulfate (SDS). Several immediate-release formulations were manufactured using the commercial raw material characterized as amorphous solid. The hydrophobic adjutant magnesium stearate was employed in some formulations due to its negative effect in the wettability and dissolution efficacy of solid dosages. These formulations showed the lower dissolution efficacy values in media without surfactant; however, when SDS was added to the medium, the dissolution efficacy increased, and the discriminatory power was lost. In spite of micellar solubilization does not increase the ROSC solubility, it modifies the discriminatory power of the assay method, increasing the wettability of the powder mixtures. The crystalline form M of ROSC was recrystallized in our laboratory, and it showed lower solubility in water than amorphous solid. However, its dissolution properties were not influenced by SDS. These results are important to develop dissolution assays for other hydrophilic drugs with increased water solubility, once that dissolution media with surfactants increase the wettability of the formulations, leading to an overrated dissolution rate.
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Texto completo: 1 Coleções: 01-internacional Base de dados: LILACS Assunto principal: Cápsulas / Dissolução / Rosuvastatina Cálcica Tipo de estudo: Prognostic_studies Idioma: En Revista: Braz. J. Pharm. Sci. (Online) Assunto da revista: Farmacologia / Terapˆutica / Toxicologia Ano de publicação: 2019 Tipo de documento: Article / Project document País de afiliação: Brasil País de publicação: Brasil
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: LILACS Assunto principal: Cápsulas / Dissolução / Rosuvastatina Cálcica Tipo de estudo: Prognostic_studies Idioma: En Revista: Braz. J. Pharm. Sci. (Online) Assunto da revista: Farmacologia / Terapˆutica / Toxicologia Ano de publicação: 2019 Tipo de documento: Article / Project document País de afiliação: Brasil País de publicação: Brasil