학술논문

Development and Assessment of a New Oral Selenium Fast-disintegrating Tablets / セレン欠乏症患者に対する新規セレン内用速崩錠の開発
Document Type
Journal Article
Source
YAKUGAKU ZASSHI. 2023, 143(12):1039
Subject
D-mannitol·low substituted hydroxypropylcellulose·fully hydrolyzed polyvinyl alcohol mixture
essential trace element
fast-disintegrating tablet
hospital preparation
selenium
Language
Japanese
ISSN
0031-6903
1347-5231
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.