Process for preparation of esomeprazole sodium of high chemical purity and new forms of esomeprazole sodium
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United States of America Patent
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Dec 24, 2013
Grant Date -
Jul 7, 2011
app pub date -
Jul 8, 2009
filing date -
Jul 9, 2008
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Abstract
A process for preparing esomeprazole sodium comprises the steps of providing a solution of esomeprazole sodium in a solvent constituted mainly of methanol or only of methanol; and carrying out precipitation or crystallization of esomeprazole sodium from said solution. Esomeprazole sodium is preferably obtained from pure form of neutral racemate through chiral chromatography using methanol-based mobile phase, and a subsequent reaction with sodium source. Novel crystal and semicrystal forms of esomeprazole sodium can be provided repeatedly and in physically stable and highly pure form.
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