Process for the preparation of a medicament comprising vardenafil hydrochloride trihydrate

摘要

The present invention relates to a process for the preparation of a medicament containing vardenafil hydrochloride trihydrate in solid form, in which vardenafil hydrochloride trihydrate is processed with suitable pharmaceutical auxiliaries at a temperature of from approx. 20° C. to approx. 45° C.

主权项

1. A process for the preparation of a medicament containing vardenafil hydrochloride trihydrate in solid form, characterized in that vardenafil hydrochloride trihydrate is processed with suitable pharmaceutical auxiliaries at a temperature of from approx. 20° C. to approx. 45° C., the relative humidity of the processing atmosphere is approx. 30% to approx. 90%, and the processed medicament is coated with a film in a further step at a temperature of from approx. 40° C. to approx. 55° C., the entire process being carried out without a rehydration step, whereby vardenafil hydrochloride trihydrate is processed to the medicament in solid form without loss of hydrate during the entire process.