Abstract This study was intended to design an orally disintegrating tablet (ODT) formulation that can mask the extremely bitter and metallic taste of phencynonate HCl by novel ion-exchange resins. The drug–resin complexes (DRCs) were prepared and characterized by scanning electron microscopy, X-ray powder diffraction and differential scanning calorimetry. In vitro properties (dissolution, wetting time and disintegration time) and in vivo behavior (disintegration time and taste-masking effect) in healthy volunteers of the prepared ODTs were also investigated. The drug was changed from the crystal structure to the amorphous form in the DRC. Compared with commercial tablets, the in vitro and in vivo disintegration of optimized DRC-loaded ODTs with a drug-resin ratio of 1:1 was greatly improved and better palatability with a low bitterness index (0.33) was obtained. The current DRC-loaded ODT could promise a good way to mask the unpleasant taste of certain drugs and accordingly improve the patient compliance.

中文翻译：

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离子交换树脂掩味盐酸苯壬酸酯口腔崩解片的制备及评价

摘要 本研究旨在设计一种口腔崩解片 (ODT) 配方，该配方可以通过新型离子交换树脂掩盖盐酸苯环壬酸酯的极苦和金属味。制备了药物-树脂复合物（DRC），并通过扫描电子显微镜、X 射线粉末衍射和差示扫描量热法对其进行表征。还研究了制备的 ODT 在健康志愿者中的体外特性（溶解、润湿时间和崩解时间）和体内行为（崩解时间和掩味效应）。在 DRC 中，药物从晶体结构变为无定形形式。与市售片剂相比，优化的载药 DRC 的 ODTs 的体外和体内崩解度为 1:1，具有更好的适口性和较低的苦味指数 (0. 33) 获得。当前加载 DRC 的 ODT 有望成为掩盖某些药物令人不快的味道并相应提高患者依从性的好方法。