UNGAP best practice for improving solubility data quality of orally administered drugs

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  • M. Vertzoni
  • J. Alsenz
  • P. Augustijns
  • A. Bauer-Brandl
  • C. A.S. Bergström
  • J. Brouwers
  • Müllertz, Anette
  • G. Perlovich
  • C. Saal
  • K. Sugano
  • C. Reppas

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.

Original languageEnglish
Article number106043
JournalEuropean Journal of Pharmaceutical Sciences
Number of pages21
Publication statusPublished - 1 Jan 2022

Bibliographical note

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

    Research areas

  • Best Practice, Exerimental Methods, Oral drug absorption, Solubility, Terminology, UNGAP

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