abstract |
An orally applicable pharmaceutical composition comprising a therapeutically effective amount of pramipexole or its pharmaceutically acceptable salts and at least one pharmaceutically acceptable excipient, said composition exhibiting at least (a) an in vitro release profile, with an average of no more than about 20% of pramipexole dissolved in the course 2 hours after warming up the composition with a standard breath test; and (b) in vivo absorption of pramipexole after oral administration of a single dose to healthy adults, with a time to reach 20% absorption on average greater than approximately 2 hours and / or a time to achieve 40% absorption on average greater than approximately 4 hours. The composition is useful for oral administration, no more than once daily, to a subject having a condition or disease for which a dopamine receptor agonist is indicated. |