Amorphous esomeprazole hydrate

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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Reexamination Certificate

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07638634

ABSTRACT:
The present invention relates to a novel amorphous form of esomeprazole hydrate, to a process for its preparation and to a pharmaceutical composition containing it. Thus, tetrahydrofuran and water are added to esomeprazole potassium salt at 25-30° C., cooled to 20° C. and then the pH is adjusted to 7.5-8.0 with acetic acid. The reaction mass is cooled to 5° C., stirred for 2 to 3 hours at 0-5° C., filtered the mass, washed with chilled mixture of water and tetrahydrofuran (2:1) and again washed with water. The wet cake is dried at 30-35° C. under vacuum to reach the moisture content to 25-30%. The solid is again dried in rotovapour at 25-30° C. under nitrogen atmosphere to give amorphous esomeprazole hydrate.

REFERENCES:
patent: 4738974 (1988-04-01), Briindstrom
patent: 5714504 (1998-02-01), Lindberg et al.
patent: 5877192 (1999-03-01), Lindberg
patent: 6369085 (2002-04-01), Cotton et al.
patent: 0005129 (1979-03-01), None
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patent: 27988 (1993-05-01), None
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patent: 2004002982 (2004-01-01), None
patent: 2004020436 (2004-03-01), None
patent: 2004076440 (2004-03-01), None
PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, or the Declaration Dated Jun. 15, 2005.

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