The invention relates to a pharmaceutical composition with a sustained release for an oral administration of a once-daily dosage form comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof, 30-60% of HPMC (hypromellose), 40-70% of starch 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, when administered once daily, exhibits a bio availability substantially equivalent to an equal daily dose of an immediate-release pramipexole dihydrochloride, for example, Mirapext tablets administered three times a day, wherein the composition exhibits 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 conducted according to USP 24 using Apparatus 1 with a spindle rotation speed of 100 rpm and a dissolution medium of 0.05M phosphate buffer, pH 6.8, at 37°C. The invention also relates to a method of treatment of a subject having a condition or disorder for which a dopamine receptor agonist is indicated, the method comprising orally administering to the subject, not more than once daily. The invention provides a dosage form of pramipexole administered once daily in which possible side effects not exceeding such in pramipexole tablets of an immediate-release administered three times a day.Изобретение относится к фармацевтической композиции с замедленным высвобождением для орального применения один раз в
