Evaluating the discriminatory power of a dissolution assay for rosuvastatin calcium capsules: Solid-state properties and dissolution media

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...

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Bibliographic Details
Published in:Brazilian Journal of Pharmaceutical Sciences 2019, Vol.55
Main Authors: 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
Format: Article
Language:English
Subjects:
Bioavailability
Chromatography
Crystal polymorphism
Dissolution
Drug dosages
FDA approval
Fourier transforms
Laboratories
Pharmaceutical industry
PHARMACOLOGY & PHARMACY
Solid dosage form
Solubility
Thermal analysis
X-ray powder diffractometry
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Summary: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.
ISSN:2175-9790
1984-8250
2175-9790
DOI:10.1590/s2175-97902019000117520