Solubility is a key physicochemical parameter with a direct effect on oral absorption and the overall developability of any New Chemical Entity

Methodology

• Kinetic solubility: Assays start from the test compound (TC) pre-dissolved in an organic solvent (typically DMSO). After addition to a buffered aqueous solution the concentration is evaluated by liquid chromatography by fitting into a calibration curve of the TC. Assays may be done individually or in a high throughput format at any pH (typically pH=7.4).
• Thermodynamic solubility: Thermodynamic assays are equilibrium based and start from the solid form of the TC, which is added to an aqueous buffered solution. After achieving thermodynamic equilibrium the concentration of TC in the supernatant is determined by liquid chromatography by fitting in a calibration curve of the TC.
• pH-solubility profile: Thermodynamic solubility data at different gastrointestinal pHs may be graphed to help establish the boundaries of best absorption and bioavailability.

Turnaround time: 3 days