Abstract
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.
Highlights
A major issue when considering published solubility data for a spe cific compound is the variability of reported values
The kinetic solubility of a compound in a certain medium can be defined as the maximum concentration of the compound that can be added to the medium from a highly concentrated solution without precipitation in a relatively short time course (Sugano et al, 2007; Alsenz et al, 2007)
If the particle sizes of the suspension are not controlled beforehand, particle size distributions can be estimated by curve fitting (Andersson et al, 2016); the quantitative data for intrinsic dissolution rates normalized by surface area become more uncertain
Summary
A major issue when considering published solubility data for a spe cific compound is the variability of reported values. Solubility is a physicochemical property of a compound in a certain medium that is only defined at a thermodynamic equilibrium between solute and solid phase. In the pharmaceutical in dustry, the term solubility not always refers to a solution at equilibrium In this respect, the kinetic solubility of a compound in a certain medium can be defined as the maximum concentration of the compound that can be added to the medium from a highly concentrated solution without precipitation in a relatively short time course (Sugano et al, 2007; Alsenz et al, 2007). The inherent instability of an amorphous form complicates the accurate assessment of amorphous solubility values (Almeida et al, 2015)
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