Boehringer Ingelheim International Gmbh

Pharmacia Corporation

Ernest J Lee

Joseph P Reo

Alice C Martino

Joseph Peter Reo

John Mark Heimlich

Gerard M Bredael

Connie Jo Skoug

Robert Martin Noack

Loksidh Devi Ganorkar

Gregory Everett Amidon

Mark J Heintz

Steven R Cox

John R Baldwin

John M Heimlich

Loksidh D Ganorkar

Gregory E Amidon

Robert M Noack

Connie J Skoug

An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof 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 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.

Pramipexole once-daily dosage form

A sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprises a water-soluble salt of pramipexole, dispersed in a matrix comprising a hydrophilic polymer and a starch having a tensile strength of at least about 0.15 kN cmat a solid fraction representative of the tablet.

Sustained-release tablet composition of pramipexole

Growing community of inventors

Kalamazoo, MI, United States of America

Ernest J Lee