| abstract |
The blended propylene glycol / ethanol solvate of tiotropium bromide of formula V contains ethanol in the range of 3000 to 40,000 ppm (0.3 to 4% by weight) and propylene glycol in the range of 3000 to 40,000 ppm (0.3 to 4% by weight), and exhibits characteristic peaks in powder X-ray recording. The process for preparing a mixed solvate of tiotropium bromide is characterized in that the tiotropium bromide form selected from the anhydrous form, hydrate, solvate or mixed solvate is dissolved in a mixture of propylene glycol and ethanol at a temperature between 40 degC to the boiling point of the solvent and the resulting solution is cooled and the precipitated solvate is isolated. The tiotropium bromide solvate is used to prepare the inhaled medicament. |