Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan

Asami Ono; Naoya Matsumura; Takahiro Kimoto; Yoshiyuki Akiyama; Satoko Funaki; Naomi Tamura; Shun Hayashi; Yukiko Kojima; Masahiro Fushimi; Hiroshi Sudaki; Risa Aihara; Yuka Haruna; Maiko Jiko; Masaru Iwasaki; Takuya Fujita; Kiyohiko Sugano

doi:10.5599/admet.704

Authors

Asami Ono Asahi Kasei Pharma Corporation, 632-1 Mifuku, Izunokuni, Shizuoka 410-2321, Japan
Naoya Matsumura Ono Pharmaceutical Co., Ltd., 3-3-1, Sakurai, Shimamoto-cho, Mishima-gun,Osaka 618-8585, Japan
Takahiro Kimoto Central Pharmaceutical Research Institute, Japan Tobacco Inc, 1-1 Murasaki-cho, Takatsuki,Osaka 569-1125, Japan
Yoshiyuki Akiyama Central Pharmaceutical Research Institute, Japan Tobacco Inc, 1-1 Murasaki-cho, Takatsuki,Osaka 569-1125, Japan
Satoko Funaki Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka-shi,Osaka 561-0825, Japan
Naomi Tamura Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka-shi,Osaka 561-0825, Japan
Shun Hayashi Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugadenaka, Konohana-ku, Osaka 554-0022, Japan
Yukiko Kojima Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan
Masahiro Fushimi Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan
Hiroshi Sudaki Nippon Boehringer Ingelheim Co. Ltd., 6-7-5 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
Risa Aihara Nippon Boehringer Ingelheim Co. Ltd., 6-7-5 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
Yuka Haruna Towa Pharmaceutical Co., Ltd., 134 Chudoji Minami-machi, Shimogyo-ku, Kyoto 600-8813, Japan
Maiko Jiko Towa Pharmaceutical Co., Ltd., 134 Chudoji Minami-machi, Shimogyo-ku, Kyoto 600-8813, Japan
Masaru Iwasaki Daiichi Sankyo RD Novare Co., Ltd, 1-16-13 Kitakasai, Edogawa-ku, Tokyo 134-8630, Japan
Takuya Fujita College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577, Japan
Kiyohiko Sugano College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577, Japan

DOI:

https://doi.org/10.5599/admet.704

Keywords:

shake-flask solubility, equilibrium solubility, poorly water-soluble drugs

Abstract

The purpose of the present study was to harmonize the protocol of equilibrium solubility measurements for poorly water-soluble drugs to lower inter-laboratory variance. The “mandatory” and “recommended” procedures for the shake-flask method were harmonized based on the knowledge and experiences of each company and information from the literature. The solubility of model drugs was measured by the harmonized protocol (HP) and the non-harmonized proprietary protocol of each company (nonHP). Albendazole, griseofulvin, dipyridamole, and glibenclamide were used as model drugs. When using the nonHP, the solubility values showed large inter-laboratory variance. In contrast, inter-laboratory variance was markedly reduced when using the HP.