UNGAP best practice for improving solubility data quality of orally administered drugs
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UNGAP best practice for improving solubility data quality of orally administered drugs. / Vertzoni, M.; Alsenz, J.; Augustijns, P.; Bauer-Brandl, A.; Bergström, C. A.S.; Brouwers, J.; Müllerz, A.; Perlovich, G.; Saal, C.; Sugano, K.; Reppas, C.
In: European Journal of Pharmaceutical Sciences, Vol. 168, 106043, 01.01.2022.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - UNGAP best practice for improving solubility data quality of orally administered drugs
AU - Vertzoni, M.
AU - Alsenz, J.
AU - Augustijns, P.
AU - Bauer-Brandl, A.
AU - Bergström, C. A.S.
AU - Brouwers, J.
AU - Müllerz, A.
AU - Perlovich, G.
AU - Saal, C.
AU - Sugano, K.
AU - Reppas, C.
N1 - Funding Information: This article is based upon work from COST Action UNGAP (CA16205), supported by COST (European Cooperation in Science and Technology), funded by the Horizon 2020 Framework Programme of the European Union. Publisher Copyright: © 2021
PY - 2022/1/1
Y1 - 2022/1/1
N2 - An important goal of the European Cooperation in Science and Technology (COST) Action UNGAP (UNderstanding Gastrointestinal Absorption-related Processes, www.ungap.eu) is to improve standardization of methods relating to the study of oral drug absorption. Solubility is a general term that refers to the maximum achievable concentration of a compound dissolved in a liquid medium. For orally administered drugs, relevant information on drug properties is crucial during drug (product) development and at the regulatory level. Collection of reliable and reproducible solubility data requires careful application and understanding of the limitations of the selected experimental method. In addition, the purity of a compound and its solid state form, as well as experimental parameters such as temperature of experimentation, media related factors, and sample handling procedures can affect data quality. In this paper, an international consensus developed by the COST UNGAP network on recommendations for collecting high quality solubility data for the development of orally administered drugs is proposed.
AB - An important goal of the European Cooperation in Science and Technology (COST) Action UNGAP (UNderstanding Gastrointestinal Absorption-related Processes, www.ungap.eu) is to improve standardization of methods relating to the study of oral drug absorption. Solubility is a general term that refers to the maximum achievable concentration of a compound dissolved in a liquid medium. For orally administered drugs, relevant information on drug properties is crucial during drug (product) development and at the regulatory level. Collection of reliable and reproducible solubility data requires careful application and understanding of the limitations of the selected experimental method. In addition, the purity of a compound and its solid state form, as well as experimental parameters such as temperature of experimentation, media related factors, and sample handling procedures can affect data quality. In this paper, an international consensus developed by the COST UNGAP network on recommendations for collecting high quality solubility data for the development of orally administered drugs is proposed.
KW - Best Practice
KW - Exerimental Methods
KW - Oral drug absorption
KW - Solubility
KW - Terminology
KW - UNGAP
U2 - 10.1016/j.ejps.2021.106043
DO - 10.1016/j.ejps.2021.106043
M3 - Journal article
C2 - 34662708
AN - SCOPUS:85118509657
VL - 168
JO - Norvegica Pharmaceutica Acta
JF - Norvegica Pharmaceutica Acta
SN - 0928-0987
M1 - 106043
ER -
ID: 306901946