Tawakkul Mobin A, Shah Rakhi B, Zidan Ahmed, Sayeed Vilayat A, Khan Mansoor A
Division of Product Quality Research/Office of Testing and Research, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences, Silver Spring, Maryland 20993-002, USA.
Pharm Dev Technol. 2009;14(4):409-21. doi: 10.1080/10837450802712666.
The purpose of the study was to investigate the complexation between a weakly basic drug (risperidone) and an ion exchange resin (amberlite IRP-64) used as a taste-masking agent via two preparation methods: physical mixture and solvent evaporation. Both methods were prepared in different drug-to-resin ratios by weight (1:1, 1:2, 1:4, 1:6). Physicochemical characterizations were performed using differential scanning calorimetry, x-ray diffraction, infra-red spectroscopy, Raman spectroscopy, near infra-red spectroscopy, chemical imaging and drug release studies. These physicochemical techniques revealed that risperidone formed complex with the resin via the solvent evaporation method where enhanced dissolution occurred but not with the physical mixtures.
该研究的目的是通过两种制备方法，即物理混合法和溶剂蒸发法，研究一种弱碱性药物（利培酮）与用作掩味剂的离子交换树脂（Amberlite IRP - 64）之间的络合作用。两种方法均以不同的药物与树脂重量比（1:1、1:2、1:4、1:6）制备。使用差示扫描量热法、X射线衍射、红外光谱、拉曼光谱、近红外光谱、化学成像和药物释放研究进行了物理化学表征。这些物理化学技术表明，利培酮通过溶剂蒸发法与树脂形成了络合物，在此方法中溶出度提高，但物理混合物则未形成络合物。
