Data/hora: 05/06/2024 02:44:21

Provedor de dados: 	60	
País: 	Brazil	
Título: 	Analysis of spironolactone polymorphs in active pharmaceutical ingredients and their effect on tablet dissolution profiles	
Autores: 	Resende,Renata Cunha de; Viana,Olímpia Maria Martins Santos; Freitas,Jennifer Tavares Jacon; Bonfilio,Rudy; Ruela,André Luís Morais; Araújo,Magali Benjamim de.	
Data: 	2016-12-01	
Ano: 	2016	
Palavras-chave: 	Spironolactone/dissolution profile; Spironolactone/pharmaceutical equivalence; Spironolactone/solubility; Spironolactone/polymorphism; Drugs/quality assessment.	
Resumo: 	ABSTRACT Spironolactone (SPR) is a steroidal drug administered as a potassium-sparing diuretic for high blood pressure treatment. The drug shows incomplete gastrointestinal absorption due to its poor aqueous solubility. The physicochemical properties of SPR in crystal forms I and II suggest that differences in their aqueous solubility may lead to a lack of bioequivalence between solid-state formulations. In this study, SPR polymorphs in five batches of active pharmaceutical ingredients (APIs) from three manufacturers were characterized using powder X-ray diffraction, infrared spectroscopy, thermal analysis, and solubility measurements. SPR tablets (50 mg) were manufactured in our laboratory using API in pure form II, and API in form II contaminated with form I, which was found in a commercial batch. Physicochemical quality evaluations of the manufactured tablets, along with five SPR tablets marketed in Brazil, were performed, and results indicated differences in their dissolution profiles. In the manufactured tablets, differences were associated with the increased solubility of API in form II contaminated with form I compared to API in pure form II. In the marketed SPR tablets, the formulation composition demonstrated an important role in the dissolution rate of the drug, leading to lack of pharmaceutical equivalence among the drug products.	
Tipo: 	Info:eu-repo/semantics/article	
Idioma: 	Inglês	
Identificador: 	http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400613	
Editor: 	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas	
Relação: 	10.1590/s1984-82502016000400005	
Formato: 	text/html	
Fonte: 	Brazilian Journal of Pharmaceutical Sciences  v.52 n.4 2016	
Fonte: 	info:eu-repo/semantics/openAccess