ERNEST J. LEE,GERARD M. BREDAEL,JOHN R. BALDWIN,STEVEN R. COX,MARK J. HEINTZ
申请号:
PT03771959
公开号:
PT1536792E
申请日:
2003.07.25
申请国别(地区):
PT
年份:
2013
代理人:
摘要:
An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipients, 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 administration to healthy adult 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. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.