Patent ID: 8175815

Claim:
A method for assessing effects of excipients, pH and/or combinations thereof on absorption properties of a low solubility compound, comprising the step of assessing a change in a flux function for a plurality of combinations of the low solubility compound and excipients with at least one predefined pH value; wherein the step of assessing the change of flux function comprises the steps of: (a) providing a calibration donor solution in a first donor chamber separated from a first receiver chamber by a first membrane member, the calibration donor solution comprising the compound and having a predefined pH value; and providing a donor solution in a second donor chamber separated from a second receiver chamber by the membrane member, the donor solution comprising the compound and a first excipient and having the predefined pH value; (b) providing a receiver solution in the first and second receiver chambers, the receiver solution being free of the compound and the first excipient, and having the predefined pH value; (c) incubating the solutions for a predefined period of time; (d) measuring a solubility of the compound in the calibration donor solution and in the donor solution and measuring a permeability of the calibration donor solution and the donor solution by measuring respective amounts of the compound in the donor solution in the first and second donor chambers and in the receiver solutions of the first and second receiver chambers after the incubation; (e) determining a first ratio between the amount of the compound in the receiver solution of the first receiver chamber and the amount of the compound in the receiver solution of the second receiver chamber; (f) repeating steps (a) to (e) for a second excipient to determine a second ratio between the measurements of the amounts of the compound in the receiver solution of the first receiver chamber and the measurement of the amount of the compound in the receiver solution of the second receiver chamber using the second excipient; and (g) assessing changes due to the effects of the first and second excipients by comparing the first and second ratios.