abstract |
The present disclosure relates to a novel form of anhydrous tiotropium bromide, processes for the preparation of anhydrous tiotropium bromide, pharmaceutical compositions comprising anhydrous tiotropium bromide and uses of the compositions. The disclosure further provides a process for the preparation of anhydrous tiotropium bromide, comprising the steps of: providing a solution of scopine di-(2-thienyl)glycolate and a ketone as the first organic solvent; adding a solution of methyl bromide in a second organic solvent to the mixture from step (a) or vice versa; isolating anhydrous tiotropium bromide from the mixture obtained in step (b); and drying the isolated anhydrous tiotropium bromide. The anhydrous tiotropium bromide may be used in the treatment of a respiratory disorder, such as asthma or COPD, wherein the COPD includes chronic bronchitis and emphysema, and my be administered from a dry powder inhaler (DPI), an aqueous nebulizer or a pressurized metered dosage inhaler (pMDI). |