Process for the preparation of esomeprazole magnesium in a stable form
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United States of America Patent
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Jan 29, 2013
Grant Date -
Jan 21, 2010
app pub date -
Jul 21, 2009
filing date -
Jul 21, 2008
priority date (Note) -
Expired
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Abstract
There is provided a process for preparing purified esomeprazole magnesium, comprising the steps of: providing esomeprazole magnesium; contacting said esomeprazole magnesium with a non-solvent comprising an aqueous component up to a maximum content defined by water saturation in the non-solvent; and recovering purified esomeprazole magnesium formed from the contacting step. The process is particularly suitable to obtain esomeprazole magnesium dihydrate, especially form A. The esomeprazole magnesium obtained is remarkably pure, stable and is resistant to form interchangeability.
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