FIELD: medicine, pharmaceutics.
SUBSTANCE: present invention refers to a method for preparing a medicinal agent containing vardenafil hydrochloride trihydrate in the solid form wherein vardenafil hydrochloride trihydrate is treated with suitable pharmaceutical additives at temperature from approximately 20°C to approximately 45°C. The ambient relative humidity of the procedure makes 30% to 90%. The treated medicinal agent is film-coated at temperature within the range from 40°C to 55°C.
EFFECT: method according to the invention provide the additional stage of repeated hydration for the purpose of preparing the trihydrate form of vardenafil hydrochloride.
20 cl, 3 dwg, 10 ex
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Authors
Dates
2013-09-27—Published
2008-06-12—Filed