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(11)    Patent No :    AP 2218    (73) Applicant(s)       
(21)    Application No :    AP/P/2004/003145    PFIZER PRODUCTS INC., Eastern Point Road, Groton,       
            Connecticut 06340,       
                   
(22)    Filing Date :    14.05.2004    United States of America       
(24)    Date of Grant &    20.04.2011           
                   
(45)    Publication :

(30)  Priority Data    (72) Inventors

    (33) Country    (31) Number    (32) Date    HAGEN Timothy Arthur, United States of America   
    US            60/527,084    04.12.2003    HERBIG Scott Max, United States of America   
                           
                        LO Julian Belknap, United States of America   
                        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    C07H 17/00 (2006.01)    A61K 9/00 (2006.01)   
                    A61K 9/16 (2006.01)       
(54)    Title

Azithromycin dosage forms with reduced side effects

(57)    Abstract

An oral dosage form comprising azithromycin and an effective amount of an alkalizing agent. Preferably, said oral dosage form comprises an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule. Additionally disclosed is an oral suspension comprising azithromycin, an effective amount of an alkalizing agent and a vehicle. Preferably, the azithromycin is in multiparticulate form wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer. Also disclosed

is a method for reducing gastrointestinal side effects, associated with administering azithromycin to a mammal, comprising contiguously administering azithromycin and an effective amount of alkalizing agent to said mammal wherein the frequency of gastrointestinal side effects is lower than that experienced by administering an equal dose of azithromycin without said

alkalizing agent. Further disclosed is a method of treating a bacterial or protozoal infection in a mammal in need thereof comprising contiguously administering to said mammal a single dose of an oral dosage form wherein said oral dosage form comprises azithromycin and an effective amount of an alkalizing agent. Additionally disclosed are azithromycin multiparticulates

(56)    Documents Cited :    EP 0 679 400 A   WO 03/063838 A   US 5 633 006 A

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