Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka; 52-1 Yada Suruga-ku, Shizuoka 422-8526, Japan.
CMC Regulatory, Pharmaceutical Science and Technology CFU, Medicine Development Center, Eisai Co., Ltd. 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan.
Acta Pharm. 2023 Jan 24;73(1):107-119. doi: 10.2478/acph-2023-0007. Print 2023 Mar 1.
This study aimed to elucidate the characteristics and pharmacokinetics of orally disintegrating tablets (ODTs) containing coenzyme Q10 (CoQ10) granules prepared by spray drying, hot-melting, and wet granulation. The hardness and disintegration times of CoQ10-ODTs containing 5 % crospovidone were 61.6-81.8 N and < 30 s, respectively; these values indicate that the as-prepared ODTs were adequate for clinical use. The hardness and disintegration times of all ODTs did not change significantly after a 28-day storage period at 30 °C/10 % relative humidity (RH), but storage under high temperature and humidity affected their characteristics. The dissolution and pharmacokinetics of CoQ10-ODTs showed that ODTs prepared using the spray-drying method had the highest dissolution and absorbability among the CoQ10-ODTs tested. These results provide useful information for the preparation of ODTs using CoQ10.
本研究旨在阐明通过喷雾干燥、热熔和湿法制粒制备的含有辅酶 Q10（CoQ10）颗粒的口腔崩解片（ODTs）的特性和药代动力学。含有 5%交联聚维酮的 CoQ10-ODTs 的硬度和崩解时间分别为 61.6-81.8 N 和 <30 s；这些值表明所制备的 ODTs 足以用于临床使用。在 30°C/10%相对湿度（RH）下储存 28 天后，所有 ODTs 的硬度和崩解时间均无明显变化，但高温高湿储存会影响其特性。CoQ10-ODTs 的溶出度和药代动力学研究表明，在所测试的 CoQ10-ODTs 中，喷雾干燥法制备的 ODTs 具有最高的溶出度和吸收性。这些结果为 CoQ10 的 ODTs 制备提供了有用的信息。
