Medicaments containing vardenafil hydrochloride trihydrate
AssigneeBayer Intellectual Property GmbH
InventorsPeter Serno, Alfons Grunenberg, Andreas Ohm, Rainer Bellinghausen, Eimer Vollers, Jan-Olav Henck
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Abstract
The invention relates to a method for producing medicaments that contain vardenafil hydrochloride, essentially as trihydrate in solid form, and to medicaments that can be obtained according to this method.
Claims19
A method for producing medicaments in the form of a coated tablet comprising vardenafil hydrochloride trihydrate and one or more excipients, said method comprising the steps of
- a) providing a tablet containing vardenafil hydrochloride, irrespective of which polymorphic form or mixture of polymorphic forms of vardenafil hydrochloride is initially present in the tablet, plus one or more excipients including a disintegrant;
- b) treating said tablet with a moistened gas for sufficient time to convert at least 90 mol % of the vardenafil hydrochloride into the trihydrate form;
- and
- c) coating said tablet with a coating agent.
A method for producing medicaments in the form of a coated tablet comprising vardenafil hydrochloride trihydrate and one or more excipients, said method comprising the steps of
- a) providing a tablet containing vardenafil hydrochloride, irrespective of which polymorphic form or mixture of polymorphic forms of vardenafil hydrochloride is initially present in the tablet, plus one or more excipients including a disintegrant;
- b) coating said tablet with a coating agent;
- and
- c) treating said tablet with a moistened gas for sufficient time to convert at least 90 mol % of the vardenafil hydrochloride into the trihydrate form.
Dependencies are inferred from the claim text.