Method for preparation of pharmaceutical-grade dithiocarbamate

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A01N 47/10 (2006.01) C07C 333/00 (2006.01) C07C 333/16 (2006.01)

Patent

CA 2362166

The present invention provides methods for producing pharmaceutical-grade particulate dithiocarbamates from secondary amines by vigorously contacting at least one secondary amine and a pharmaceutically acceptable diluent that is a solvent for the carbon disulfide, but not for the secondary amine in an inert gas atmosphere, cooling the mixture so as to precipitate the dithiocarbamate therefrom, and separating the precipitated dithiocarbamate from the cooled mixture. The preferred solvent contains absolute ethanol. In alternative embodiments, the invention further provides methods for purifying a dithiocarbamate to obtain a pharmaceutical-grade dithiocarbamate particulate from a dithiocarbamate feed and methods for producing a sterile pharmaceutical- grade dithiocarbamate from a dithiocarbamate feed.

L'invention concerne des procédés permettant de produire des dithiocarbamates particulaires de classe pharmaceutique à partir d'amines secondaires. Ces procédés consistent à mélanger énergiquement dans une atmosphère gazeuse inerte au moins une amine secondaire et un diluant pharmaceutiquement acceptable qui est un solvant du bisulfure de carbone mais non de l'amide secondaire, à refroidir ce mélange de manière à précipiter le dithiocarbamate contenu dans ce dernier, puis à séparer le dithiocarbamate précipité du mélange refroidi. Le solvant préféré contient un éthanol absolu. Dans d'autres aspects l'invention concerne des procédés permettant de purifier un dithiocarbamate afin d'obtenir un dithiocarbamate particulaire à partir d'une charge de dithiocarbamate, ainsi que des procédés permettant de produire un dithiocarbamate stérile de classe pharmaceutique à partir d'une charge de dithiocarbamate.

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