期刊
PHARMACEUTICS
卷 14, 期 5, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics14050912
关键词
simvastatin; ezetimibe; solid dispersion; eutectic; dissolution improvement; fixed-dose; dyslipidemia; cardiovascular disease
资金
- Wroclaw Medical University [SUB.D240.19.008]
The simvastatin-ezetimibe solid dispersion prepared using the co-grinding method showed improved dissolution of ezetimibe regardless of simvastatin content. The study also confirmed a simple eutectic phase equilibrium diagram between simvastatin and ezetimibe.
Two active pharmaceutical ingredients (APIs) with limited solubility, simvastatin and ezetimibe, prepared as a drug-drug solid dispersion (SD) was evaluated for physicochemical, microstructural, and aqueous dissolution properties. The simvastatin-ezetimibe SD was prepared using the co-grinding method in a wide range of weight fractions and differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD) were used to perform the phase composition analysis. DSC studies confirmed that simvastatin and ezetimibe form a simple eutectic phase equilibrium diagram. Analysis of Fourier transform infrared spectroscopy (FTIR) studies excluded strong interactions between the APIs. Our investigations have revealed that all studied dispersions are characterized by substantially improved ezetimibe dissolution regardless of simvastatin content, and are best when the composition oscillates near the eutectic point. Data obtained in our studies provide an opportunity for the development of well-formulated, ezetimibe-simvastatin fixed-dose combinations (for hypercholesterolemia treatment) with reduced ezetimibe dosages based on its dissolution improvement.
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