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

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.

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Published

04-08-2019

How to Cite

Ono, A., Matsumura, N., Kimoto, T., Akiyama, Y., Funaki, S., Tamura, N., Hayashi, S., Kojima, Y., Fushimi, M., Sudaki, H., Aihara, R., Haruna, Y., Jiko, M., Iwasaki, M., Fujita, T., & Sugano, K. (2019). Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan. ADMET and DMPK, 7(3), 183–195. https://doi.org/10.5599/admet.704

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Section

Original Scientific Articles