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(12) PATENT APPLICATION PUBLICATION (21) Application No.6629/DELNP/2008 A<br />

(19) INDIA<br />

(22) Date <strong>of</strong> filing <strong>of</strong> Application :30/07/2008 (43) Publication Date : 24/10/2008<br />

(54) Title <strong>of</strong> the invention : "ANTI-HISTAMINE COMPOSITIONS AND USE THEREOF"<br />

(51) International classification :A61K 31/19 (71)Name <strong>of</strong> Applicant :<br />

(31) Priority Document No :60/761,832<br />

1)TARO PHARMACEUTICALS NORTH AMERICA, INC<br />

(32) Priority Date :25/01/2006<br />

Address <strong>of</strong> Applicant :P.O.BOX 1034 GT,,HARBOUR<br />

(33) Name <strong>of</strong> priority country :U.S.A.<br />

PLACE, 4TH FLOOR, 103 SOUTH CHURCH STREET,<br />

(86) International Application No :PCT/US2007/001875 CAYMAN ISLAND Cayman Isl<strong>and</strong><br />

Filing Date<br />

:25/01/2007 (72)Name <strong>of</strong> Inventor :<br />

(87) International Publication No :WO 2007/087344 1)ASOTRA SATISH<br />

(61) Patent <strong>of</strong> Addition to Application<br />

Number<br />

Filing Date<br />

:NA<br />

:NA<br />

2)ZADYKOWICZ JERZY<br />

3)VANAM KALPANA R<br />

4)GAO SHEN<br />

(62) Divisional to Application Number :NA<br />

Filing Date<br />

:NA<br />

(57) Abstract :<br />

The present invention provides for a storage stable pharmaceutical liquid solution for oral administration having a pharmaceutically<br />

effective amount <strong>of</strong> an antihistamine <strong>and</strong> having a purity equal to or greater than about 99% by weight-based HPLC assay, residual<br />

solvents <strong>of</strong> less than about 0.5%, <strong>and</strong> a total impurity <strong>of</strong> less than about 0.2%. The storage stable solution preferably contains<br />

cetirizine. The present invention further provides a process <strong>of</strong> preparing the storage stable pharmaceutical liquid solution as well as a<br />

method <strong>of</strong> treating a mammal with a therapeutically effective amount <strong>of</strong> cetirizine in the stable pharmaceutical liquid solution.<br />

No. <strong>of</strong> Pages : 13 No. <strong>of</strong> Claims : 16<br />

The Patent Office Journal 24/10/2008 26118

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