摘要 |
<p>PROBLEM TO BE SOLVED: To provide a stable crystalline form of tiotropium bromide which is an extremely efficient anticholinergic drug with specificity for muscarinic receptors and an extensive long-term effect, and a process for its preparation with high purity.SOLUTION: There are provided a process for recrystallization of tiotropium bromide from a solution of tiotropium bromide ((1α,2β,4β,7β)-7-[(hydroxy-di-2-thienyl acetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0]nonane bromide) and a crystalline form obtained by the process. There is further provided a process for preparation of crystalline tiotropium bromide by conducting crystallization in the presence of one or more kind further solvent selected from tert-butyl methyl ether, ethyl formate and acetonitrile.</p> |