Measurement and prediction of dabigatran etexilate mesylate Form II solubility in mono-solvents and mixed solvents

• Solubility of DEM Form II in mono-solvents and binary solvent mixtures was measured.
• Regressed UNIFAC model was used to predict the solubility in solvent mixtures.
• The experimental solubility data were correlated by different models.

UV spectrometer method was used to measure the solubility data of dabigatran etexilate mesylate (DEM) Form II in five mono-solvents (methanol, ethanol, ethane-1,2-diol, DMF, DMAC) and binary solvent mixtures of methanol and ethanol in the temperature range from 287.37 K to 323.39 K. The experimental solubility data in mono-solvents were correlated with modified Apelblat equation, van’t Hoff equation and λh equation. GSM model and Modified Jouyban-Acree model were employed to correlate the solubility data in mixed solvent systems. And Regressed UNIFAC model was used to predict the solubility of DEM Form II in the binary solvent mixtures. Results showed that the predicted data were consistent with the experimental data.

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