Górniak Agata, Czapor-Irzabek Hanna, Złocińska Adrianna, Gawin-Mikołajewicz Agnieszka, Karolewicz Bożena
Laboratory of Elemental Analysis and Structural Research, Wroclaw Medical University, Borowska 211A, 50-556 Wroclaw, Poland.
Department of Drug Form Technology, Wroclaw Medical University, Borowska 211A, 50-556 Wroclaw, Poland.
Pharmaceutics. 2023 Feb 10;15(2):603. doi: 10.3390/pharmaceutics15020603.
The combination of statins and fibrates in the treatment of lipid abnormalities effectively regulates individual lipid fraction levels. In this study, the screening and assessment of the physicochemical properties of simvastatin-fenofibrate solid dispersions were performed. Fenofibrate and simvastatin were processed using the kneading method in different weight ratios, and the resulting solid dispersions were assessed using differential scanning calorimetry (DSC), X-ray powder diffractometry (XRPD), Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), contact angle, as well as dissolution tests. The obtained results confirmed the formation of a simple eutectic phase diagram, with a eutectic point containing 79 wt% fenofibrate and 21 wt% simvastatin, lack of chemical interactions between the ingredients, and simvastatin impact on improving fenofibrate dissolution profile, due to the formation of crystalline solid dispersions by the kneading method.
他汀类药物与贝特类药物联合用于治疗脂质异常可有效调节各个脂质组分的水平。在本研究中，对辛伐他汀 - 非诺贝特固体分散体的物理化学性质进行了筛选和评估。采用捏合法以不同重量比处理非诺贝特和辛伐他汀，并使用差示扫描量热法（DSC）、X射线粉末衍射法（XRPD）、傅里叶变换红外光谱法（FTIR）、扫描电子显微镜（SEM）、接触角以及溶出度试验对所得固体分散体进行评估。获得的结果证实形成了简单的低共熔相图，其低共熔点含有79 wt%的非诺贝特和21 wt%的辛伐他汀，成分之间不存在化学相互作用，并且由于通过捏合法形成了结晶固体分散体，辛伐他汀对改善非诺贝特的溶出曲线有影响。
