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不同方法制备的含辅酶 Q10 颗粒的口腔崩解片的片剂特性和药代动力学。

Tablet characteristics and pharmacokinetics of orally disintegrating tablets containing coenzyme Q10 granules prepared by different methods.

机构信息

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.

出版信息

Acta Pharm. 2023 Jan 24;73(1):107-119. doi: 10.2478/acph-2023-0007. Print 2023 Mar 1.

Abstract

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.

摘要

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。

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