Original scientific paper

https://doi.org/10.2478/acph-2023-0007

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

YASUHARU KASHIWAGURA ; Department of Pharmacy Practice & Science, School of Pharmaceutical Sciences, University of Shizuoka; 52–1 Yada, Suruga-ku, Shizuoka 422–8526, Japan
SHOTA TAKUSAGAWA ; Department of Pharmacy Practice & Science, School of Pharmaceutical Sciences, University of Shizuoka; 52–1 Yada, Suruga-ku, Shizuoka 422–8526, Japan
YASUYUKI IKEMATSU ; Department of Pharmacy Practice & 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
SHIMAKO TANAKA ; Department of Pharmacy Practice & Science, School of Pharmaceutical Sciences, University of Shizuoka; 52–1 Yada, Suruga-ku, Shizuoka 422–8526, Japan
NORIYUKI NAMIKI ; Department of Pharmacy Practice & Science, School of Pharmaceutical Sciences, University of Shizuoka; 52–1 Yada, Suruga-ku, Shizuoka 422–8526, Japan; Faculty of Pharmaceutical Sciences, Teikyo Heisei University, 4-21-2, Nakano, Nakano-ku, Tokyo 164-8530, Japan
SHINYA UCHIDA ; Department of Pharmacy Practice & Science, School of Pharmaceutical Sciences, University of Shizuoka; 52–1 Yada, Suruga-ku, Shizuoka 422–8526, Japan

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.

Keywords

coenzyme Q10; orally disintegrating tablets; granules; spray drying; tablet characteristics; pharmacokinetics

Hrčak ID:

281776

URI

https://hrcak.srce.hr/281776

Publication date:

31.3.2023.

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