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

Author:

Kashiwagura Yasuharu1ORCID,Takusagawa Shota1,Ikematsu Yasuyuki12,Tanaka Shimako1,Namiki Noriyuki13,Uchida Shinya1ORCID

Affiliation:

1. Department of Pharmacy Practice and Science , School of Pharmaceutical Sciences University of Shizuoka ; 52–1 Yada Suruga-ku, Shizuoka 422–8526 , Japan

2. CMC Regulatory, Pharmaceutical Science and Technology CFU, Medicine Development Center, Eisai Co., Ltd . 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088 , Japan

3. Faculty of Pharmaceutical Sciences , Teikyo Heisei University , 4-21-2, Nakano Nakano-ku, Tokyo 164-8530 , Japan

Abstract

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.

Publisher

Walter de Gruyter GmbH

Subject

Pharmaceutical Science,Pharmacology,General Medicine

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