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

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 e...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: International Association of Physical Chemists 2019
Materias:
Original Scientific Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8957233/
https://www.ncbi.nlm.nih.gov/pubmed/35350659
http://dx.doi.org/10.5599/admet.704
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author 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
author_facet 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
author_sort Ono, Asami
collection PubMed
description 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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spelling pubmed-89572332022-03-28 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 ADMET DMPK Original Scientific Paper 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. International Association of Physical Chemists 2019-08-05 /pmc/articles/PMC8957233/ /pubmed/35350659 http://dx.doi.org/10.5599/admet.704 Text en Copyright © 2019 by the authors. https://creativecommons.org/licenses/by/3.0/This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/ (https://creativecommons.org/licenses/by/3.0/) ).
spellingShingle Original Scientific Paper
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
Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title_full Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title_fullStr Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title_full_unstemmed Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title_short Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan
title_sort harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (cobito) in japan
topic Original Scientific Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8957233/
https://www.ncbi.nlm.nih.gov/pubmed/35350659
http://dx.doi.org/10.5599/admet.704
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