Nilotinib hydrochloride monohydrate solubility in supercritical carbon dioxide + cosolvent: measurements and modeling.

The solubility of nilotinib hydrochloride monohydrate in supercritical CO₂ was measured at four temperatures between 338 K and 308 K, and seven pressures between 12 MPa and 30 MPa, using ethanol as a cosolvent. Both semi-empirical and empirical approaches were employed to analyze the experimental data. In the ternary systems studied, the solubility values (mole basis) for nilotinib hydrochloride monohydrate were between 1.08 × 10- 5 and 4.15 × 10- 4 (10.8 to 415 PPM). The results indicated a significant increase in solubility with the incorporation of ethanol. The peak solubility of nilotinib hydrochloride monohydrate was recorded in the ternary system at 338 K and 12 MPa, which was approximately 10.8 times its solubility in supercritical carbon dioxide alone under identical conditions. The best fit for the data, as measured by the average absolute relative deviation percentage (AARD%), was achieved using the methods proposed by MST.