PRAMIPEXOLE ONCE-DAILY DOSAGE FORM

摘要

An orally deliverable pharmaceutical composition comprises a therapeutically effectiveamount of pramipexole or a pharmaceutically acceptable salt thereof and at least onepharmaceutically acceptable excipients, said composition exhibiting at least one of (a) an invitro release profile wherein on average no more than about 20% of the pramipexole isdissolved within 2 hours after placement of the composition in a standard dissolution test; and(b) an in vivo pramipexole absorption profile following single dose administration to healthyadult humans wherein the time to reach a mean of 20% absorption is greater than about 2hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. Thecomposition is useful for oral administration, not more than once daily, to a subject having acondition or disorder for which a dopamine receptor agonist is indicated.Fig. 1