ROMIDEPSIN-BASED TREATMENTS FOR CANCER
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United States of America Patent
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Issued Date -
Sep 12, 2013
app pub date -
Apr 24, 2013
filing date -
Dec 29, 2006
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Abandoned
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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 pharmaceutical compositions of monomeric romidepsin free of dimerized, oligomerized, or polymerized adducts.
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