Mai Nguyen Ngoc Sao, Nakai Riko, Kawano Yayoi, Hanawa Takehisa
Faculty of Pharmaceutical Sciences, Tokyo University of Science, 2641 Yamazaki, Noda, Chiba 278-8510, Japan.
Pharmacy (Basel). 2020 Nov 2;8(4):203. doi: 10.3390/pharmacy8040203.
Cyclodextrins (CDs) and their derivatives significantly increase drug solubility by forming drug/CD complexes known as solid dispersions (SDs), which consist of an inclusion complex (IC), where the drug is entrapped within the CD cavity, and a non-IC. Here, the SDs of curcumin (CUR) and hydroxypropyl-β-cyclodextrin (HPβCD) were prepared using the grinding, freeze-drying (FD), and common solvent evaporation (CSE) methods and were physicochemically characterized using solubility, powder X-ray diffraction, Fourier transform infrared, differential scanning calorimetry, and dissolution studies. The second or higher order complex of CUR-HPβCD indicated the co-existence of ICs and non-ICs known as the SD system. When comparing the soluble drug amount with CUR crystals, the solubility of SDs was enhanced by up to 299-, 180-, and 489-fold, corresponding to the ground mixtures (GMs), freeze-drying mixtures (FDs), and common solvent evaporation mixtures (CSEs), respectively. The total transformation into the amorphous phase of CUR was observed in GMs and in CSE12, CSE14, and CSE18. The drug was well dispersed within HPβCD in GMs and CSEs, suggesting the formation of hydrogen bonds between CUR and HPβCD, whereas the dispersed behavior of FDs was similar to that of physical mixtures. In SDs, the melting temperature of CUR was in an increased order of CUR in 1:2 ICs, CUR in 1:1 ICs, and CUR crystals. The dissolution rate of CUR was positively improved as the amount of HPβCD in SDs increased. The SD system consisting of CUR and HPβCD significantly increased the drug solubility compared to ICs.
环糊精(CDs)及其衍生物通过形成被称为固体分散体(SDs)的药物/CD复合物来显著提高药物溶解度,固体分散体由包合物(IC)和非包合物组成,其中药物被包封在CD腔内。在此,采用研磨法、冷冻干燥法(FD)和常规溶剂蒸发法(CSE)制备了姜黄素(CUR)与羟丙基-β-环糊精(HPβCD)的固体分散体,并通过溶解度、粉末X射线衍射、傅里叶变换红外光谱、差示扫描量热法和溶出度研究对其进行了物理化学表征。CUR-HPβCD的二级或更高阶复合物表明了包合物和非包合物共存,即所谓的固体分散体系统。与CUR晶体相比,当比较可溶性药物量时,固体分散体的溶解度分别提高了299倍、180倍和489倍,分别对应研磨混合物(GMs)、冷冻干燥混合物(FDs)和常规溶剂蒸发混合物(CSEs)。在GMs以及CSE12、CSE14和CSE18中观察到CUR完全转变为无定形相。在GMs和CSEs中,药物在HPβCD中分散良好,表明CUR与HPβCD之间形成了氢键,而FDs的分散行为与物理混合物相似。在固体分散体中,CUR的熔点按以下顺序升高:1:2包合物中的CUR、1:1包合物中的CUR和CUR晶体。随着固体分散体中HPβCD含量的增加,CUR的溶出速率得到了积极改善。与包合物相比,由CUR和HPβCD组成的固体分散体系统显著提高了药物溶解度。