A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/15 (2006.01) A61K 31/453 (2006.01) A61K 31/573 (2006.01) A61K 31/706 (2006.01) A61K 31/7068 (2006.01) A61K 38/22 (2006.01) A61P 35/00 (2006.01) A61P 35/02 (2006.01)
Patent
CA 2674313
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.
L'invention concerne un meilleur procédé de préparation de la romidepsine. Le procédé implique la production, la purification ou le stockage de la romidepsine dans des conditions qui empêchent la formation de produits d'addition non souhaités. La purification de la romidepsine à un pH apparent inférieur à approximativement 6,0 (par exemple, entre un pH apparent de 4,0 et 6,0) s'est avérée empêcher la réduction de la liaison disulfure de la romidepsine et la formation ultérieure de produits d'addition dimérisés, oligomérisés ou polymérisés. L'invention concerne également des compositions pharmaceutiques de romidepsine monomère dépourvues de produits d'addition dimérisés, oligomérisés ou polymérisés.
Verdine Gregory L.
Vrolijk Nicholas H.
Fasken Martineau Dumoulin Llp
Gloucester Pharmaceuticals Inc.
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