Preparation of romidepsin
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United States of America Patent
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Apr 8, 2014
Grant Date -
Jul 23, 2009
app pub date -
Dec 28, 2007
filing date -
Dec 29, 2006
priority date (Note) -
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Abstract
The invention provides an improved process for preparing romidepsin. The process involves producing, purifying, or storing romidepsin under conditions that prevent the formation of undesired adducts. Purifying romidepsin at an apparent pH lower than approximately 6.0 (e.g., between an apparent pH of 4.0 and 6.0) has been discovered to prevent the reduction of the disulfide bond of romidepsin and the subsequent formation of dimerized, oligomerized, or polymerized adducts. The invention also provides compositions of monomeric romidepsin free of dimerized, oligomerized, or polymerized adducts.
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