Abstract：
Selenium is an essential trace element and its deficiency causes myositis, myocardial damage, and other symptoms. Patients receiving long-term intravenous nutrition or tube-feeding in particular are deficient in essential trace elements, including selenium, and require regular supplementation. In Japan, injectable selenium-containing products are listed on the National Health Insurance drug price list, and oral solutions are prepared and used in hospitals. However, these formulations have problems related to preservation and require complicated administration procedures. In this study, we developed a new fast-disintegrating tablet formulation of selenium, using SmartEx® (D-mannitol·low substituted hydroxypropylcellulose (L-HPC)·fully hydrolyzed polyvinyl alcohol (PVA) mixture) as a coprocessing additive, that can be administered orally or by feeding tube. The tablet formulation had excellent disintegrable capability, sufficient hardness, and did not cause tube blockage when administered in the simple suspension method. In addition, the tablet formulation showed no changes in properties in an accelerated test without packaging for 42 d, indicating that it could be stored for a long period. Fast-disintegrating tablets prepared with SmartEx® are expected to improve the adherence and quality of life of patients who require selenium supplementation.
摘要：
硒是一种必需的微量元素，它的缺乏会导致肌炎，心肌损伤,和其他症状。特别是接受长期静脉营养或管饲的患者缺乏必需的微量元素，包括硒,需要定期补充。在日本,可注射含硒产品列入国民健康保险药品价格表,和口服溶液的制备和使用在医院。然而,这些制剂具有与保存相关的问题并且需要复杂的给药程序。在这项研究中,我们开发了一种新的硒快速崩解片剂配方，使用SmartEx®（D-甘露醇·低取代羟丙基纤维素（L-HPC）·完全水解聚乙烯醇（PVA）混合物）作为共处理添加剂，可以口服或通过饲管给药。片剂制剂具有优异的崩解能力，足够的硬度，以简单的悬浮方法给药时，不会导致管子堵塞。此外,在没有包装的加速试验中，片剂配方在42天的特性上没有变化，这表明它可以存储很长一段时间。用SmartEx®制备的快速崩解片剂有望改善需要补充硒的患者的依从性和生活质量。
