Τίτλος:
UNGAP best practice for improving solubility data quality of orally administered drugs
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2021
Συγγραφείς:
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.
Περιοδικό:
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Λέξεις-κλειδιά:
bicalutamide; carvedilol; ciprofloxacin; solvent; water; drug, analytic method; aqueous solution; Article; aspiration; data quality; drug absorption; drug solubility; evaporation; good clinical practice; intestine; oral drug administration; solid state; solubilization; temperature; intestine absorption; measurement accuracy; oral drug administration; solubility, Administration, Oral; Data Accuracy; Intestinal Absorption; Pharmaceutical Preparations; Solubility
DOI:
10.1016/j.ejps.2021.106043
