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| Resende,Renata Cunha de; Viana,Olímpia Maria Martins Santos; Freitas,Jennifer Tavares Jacon; Bonfilio,Rudy; Ruela,André Luís Morais; Araújo,Magali Benjamim de. |
| 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... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Spironolactone/dissolution profile; Spironolactone/pharmaceutical equivalence; Spironolactone/solubility; Spironolactone/polymorphism; Drugs/quality assessment.. |
| Ano: 2016 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400613 |
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| 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. |
| 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... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Dissolution; Crystal polymorphism; Solid dosage form; X-ray powder diffractometry; Thermal analysis; Solubility. |
| Ano: 2019 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502019000100527 |
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