Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2004-11-16
2011-11-01
Ward, Paul V. (Department: 1624)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C544S242000, C544S315000, C544S330000
Reexamination Certificate
active
08048883
ABSTRACT:
This invention discloses a novel stable crystal form of imatinib mesylate, designated by us as α2Form, which is stable at room temperature and even at higher temperatures up to 120° C. and accelerated stress conditions and, freely soluble in water. This invention also discloses a pharmaceutical composition containing the novel stable α2form of Imatinib mesylate and other usually employed excipients, useful in the treatment of Chronic Myelogenous Leukemia (CML). This new α2Form of imatinib mesylate is prepared by slurrying Imatinib base in isopropanol at room temperature followed by addition of methane sulfonic acid and maintaining 50-60 ° C. followed by filtration. This invention also discloses another process for the preparation of the novel, stable α2crystalline form of Imatinib Mesylate by the conversion of Imatinib mesylate β-polymorphic modification by suspending it in water and organic solvents, distilling off water azeotropically, cooling and filtering to obtain the α2crystal form.
REFERENCES:
patent: 0 564 409 (1993-06-01), None
patent: WO 99/03854 (1999-01-01), None
patent: WO 2004/074502 (2004-09-01), None
patent: WO 2004/106326 (2004-12-01), None
Third party observations for corresponding EP application No. 04806748.2 mailed on Feb. 2, 2011.
Office Action for corresponding EP application No. 04806748.2 mailed on Feb. 7, 2011.
Adibhatla Kali Satya Bhujanga rao
Amala Kompella
Podili Khadgapathi
Rachakonda Sreenivas
Srinivasa Rao Thungathurthi
Merchant & Gould P.C.
Natco Pharma Limited
Ward Paul V.
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