Data/hora: 09/06/2024 13:24:23

Provedor de dados: 	60	
País: 	Brazil	
Título: 	Evaluating the discriminatory power of a dissolution assay for rosuvastatin calcium capsules: Solid-state properties and dissolution media	
Autores: 	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.	
Data: 	2019-01-01	
Ano: 	2019	
Palavras-chave: 	Dissolution; Crystal polymorphism; Solid dosage form; X-ray powder diffractometry; Thermal analysis; Solubility.	
Resumo: 	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.	
Tipo: 	Info:eu-repo/semantics/article	
Idioma: 	Inglês	
Identificador: 	http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502019000100527	
Editor: 	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas	
Relação: 	10.1590/s2175-97902019000117520	
Formato: 	text/html	
Fonte: 	Brazilian Journal of Pharmaceutical Sciences  v.55 2019	
Fonte: 	info:eu-repo/semantics/openAccess