Patent ID: 6761904
Filing Date: 2004-07-13
Classification: A61K

Abstract:
A pharmaceutical kit comprisinga) a controlled release pharmaceutical composition for oral use comprising midodrine (ST 1085) or a pharmaceutically acceptable salt thereof and/or its active metabolite desglymidodrine (ST 1059) or a pharmaceutically acceptable salt thereof, wherein the in vitro release rate of midodrine and/or desglymidodrine has the following properties: i) a relatively fast first initial release followed by ii) a steady release or a slower release than in step i) above, which is followed by iii) a second rise in release rate that takes place 5-10 hours after start of an in vitro dissolution test and, finally, iv) a decline in release rate so that a relatively fast peak plasma concentration of midodrine and/desglymidodrine is obtained within about 15 minutes-6 hours after administration of the composition, and a therapeutically effective plasma concentration of midodrine and/or desglymidodrine is maintained for at least about 9 hours, and b) a relatively fast onset pharmaceutical composition comprising midodrine (ST 1085) or a pharmaceutically acceptable salt thereof and/or its active metabolite desglymidodrine (ST 1059) or a pharmaceutically acceptable salt thereof, the composition being adapted to provide midodrine and/or desglymidodrine in such a manner that a relatively fast therapeutically effective concentration of desglymidodrine is obtained within about 15 minutes to about 6 hours.