Extended release midodrine hydrochloride compositions and methods of use

A pharmaceutical composition comprising:

• a first release portion comprising an active agent in a range of about 20% to about 40% (w/w) of a total amount of the active agent in the composition;
• a second release portion comprising the active agent in a range of about 60% to about 80% (w/w) of the total amount of the active agent in the composition;
• and
• a rate controlling agent, wherein the rate controlling agent is selected from the group consisting of a water-soluble excipient, a water-insoluble excipient, a water permeable excipient, and a combination thereof, and wherein the rate controlling agent is present in a weight ratio of the active agent in the second release portion of the composition to the rate controlling agent of about 1:1 to about 1:30 (w/w);
• wherein the in vitro release rate of the active agent, measured by an in vitro dissolution test comprises (i) a first release that is relatively fast and (ii) a second release, wherein the second release does not include a second rise in release rate that takes place about 5 hours to about 10 hours after start of the in vitro dissolution test,
• wherein the active agent is selected from the group consisting of midodrine, a pharmaceutically acceptable salt of midodrine, desglymidodrine, a pharmaceutically acceptable salt of desglymidodrine, and any combination thereof;
• and
• wherein the second release comprises a second rise in release rate that takes place about 2 to about 4.5 hours after start of the in vitro dissolution test.