Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
AssigneeBoehringer Ingelheim Pharma GmbH & Co. KG
InventorsRolf Banholzer, Peter Sieger, Christian Kulinna, Michael Trunk, Manfred Graulich, Peter Specht, Helmut Meissner, Andreas Mathes
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Abstract
Crystalline monohydrate of (1α,2β,4β,5α,7β)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide (tiotropium bromide monohydrate), processes for the preparation thereof, pharmaceutical compositions thereof, and their use.
Claims21
Crystalline tiotropium bromide monohydrate.
A process for preparing crystalline tiotropium bromide monohydrate, the process comprising:
- (a) dissolving tiotropium bromide in water to obtain a solution;
- (b) heating the resulting solution;
- (c) adding activated charcoal to the heated solution;
- (d) removing the activated charcoal;
- and
- (e) allowing the solution to slowly cool to obtain crystalline tiotropium bromide monohydrate.
A process for preparing crystalline tiotropium bromide monohydrate, the process comprising:
- (a) dissolving tiotropium bromide in water to obtain a solution;
- (b) heating the resulting solution to more than 50° C.;
- (c) adding activated charcoal to the heated solution;
- (d) removing the activated charcoal;
- and
- (e) allowing the solution to slowly cool to obtain crystalline tiotropium bromide monohydrate.
A process for preparing crystalline hydrates of tiotropium bromide, the process comprising:
- (a) dissolving tiotropium bromide in water to obtain a solution;
- (b) heating the resulting solution;
- and
- (c) allowing the solution to slowly cool to obtain crystalline hydrates of tiotropium bromide.
A process for preparing crystalline hydrates of tiotropium bromide, the process comprising:
- (a) dissolving tiotropium bromide in water to obtain a solution;
- (b) heating the solution of step (a);
- (c) adding activated charcoal to the heated solution of step (b);
- (d) removing the activated charcoal from the solution of step (c);
- and
- (e) allowing the solution to slowly cool to obtain crystalline hydrates of tiotropium bromide.
Dependencies are inferred from the claim text.