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(11)    Patent No :    AP 2223    (73) Applicant(s)       
(21)    Application No :    AP/P/2005/003206    PHARMACIA CORPORATION, 700 Chesterfield Parkway       
            West, Chesterfield, Missouri 63017-1732,       
                   
(22)    Filing Date :    25.07.2003    United States of America       
(24)    Date of Grant &    24.03.2011           
                   
(45)    Publication :

(30)  Priority Data    (72) Inventors

    (33) Country    (31) Number    (32) Date    LEE Ernest. J, United States of America   
    US            60/398,427    25.07.2002    BREDAEL Gererd. M, United States of America   
    US            60/398,447    25.07.2002       
                        BALDWIN John R., United States of America   
    US            60/479,514    18.06.2003       
                               
    et al                    et al       
                        (74) Representative   
(84)    Designated State           
                   
    GM    GH    KE    LS   MW  MZ    SL   SD   SZ    GALLOWAY & COMPANY   
                               
    T Z    UG    ZW                   
(51)    International    Classification    A61K 9/20 (2006.01)    A61K 9/28 (2006.01)   
                    A61K 31/426 (2006.01)       

(54)    Title

Pramipexole once-daily dosage form

(57)    Abstract

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 herein 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

(56)    Documents Cited :    US 4 731 374 A    US 6 277 875 A    WO 01 22820 A

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