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Harmonizing solubility measurement to lower inter-laboratory variance - progress of consortium of biopharmaceutical tools (CoBiTo) in Japan.
Ono, Asami; Matsumura, Naoya; Kimoto, Takahiro; Akiyama, Yoshiyuki; Funaki, Satoko; Tamura, Naomi; Hayashi, Shun; Kojima, Yukiko; Fushimi, Masahiro; Sudaki, Hiroshi; Aihara, Risa; Haruna, Yuka; Jiko, Maiko; Iwasaki, Masaru; Fujita, Takuya; Sugano, Kiyohiko.
Afiliação
  • Ono A; Asahi Kasei Pharma Corporation, 632-1 Mifuku, Izunokuni, Shizuoka 410-2321, Japan.
  • Matsumura N; Ono Pharmaceutical Co., Ltd., 3-3-1, Sakurai, Shimamoto-cho, Mishima-gun,Osaka 618-8585, Japan.
  • Kimoto T; Central Pharmaceutical Research Institute, Japan Tobacco Inc, 1-1 Murasaki-cho, Takatsuki, Osaka 569-1125, Japan.
  • Akiyama Y; Central Pharmaceutical Research Institute, Japan Tobacco Inc, 1-1 Murasaki-cho, Takatsuki, Osaka 569-1125, Japan.
  • Funaki S; Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka-shi,Osaka 561-0825, Japan.
  • Tamura N; Shionogi & Co., Ltd., 3-1-1, Futaba-cho, Toyonaka-shi,Osaka 561-0825, Japan.
  • Hayashi S; Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugadenaka, Konohana-ku, Osaka 554-0022, Japan.
  • Kojima Y; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
  • Fushimi M; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
  • Sudaki H; Nippon Boehringer Ingelheim Co. Ltd., 6-7-5 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan.
  • Aihara R; Nippon Boehringer Ingelheim Co. Ltd., 6-7-5 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan.
  • Haruna Y; Towa Pharmaceutical Co., Ltd., 134 Chudoji Minami-machi, Shimogyo-ku, Kyoto 600-8813, Japan.
  • Jiko M; Towa Pharmaceutical Co., Ltd., 134 Chudoji Minami-machi, Shimogyo-ku, Kyoto 600-8813, Japan.
  • Iwasaki M; Daiichi Sankyo RD Novare Co., Ltd, 1-16-13 Kitakasai, Edogawa-ku, Tokyo 134-8630, Japan.
  • Fujita T; College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577, Japan.
  • Sugano K; College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577, Japan.
ADMET DMPK ; 7(3): 183-195, 2019.
Article em En | MEDLINE | ID: mdl-35350659
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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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2019 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2019 Tipo de documento: Article