| 摘要 |
An orally deliverable pharmaceutical composition comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof, a starch, a hydrophilic polymer, and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose oral administration to healthy humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours, wherein said composition comprises a full daily dose contained in a single dosage unit, further wherein said composition, when administered once daily, exhibits a bioavailability substantially equivalent to that of an equal dose of an immediate-release pramipexole dihydrochloride reference formulation administered three times a day. (62) Divided Out of 537614
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