Monohydrate Salt of Denatonium Acetate
AssigneeAardvark Therapeutics Inc.
InventorsJeffrey OSTER, Andrew ZEILER
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Abstract
There is disclosed a novel monohydrate salt form of denatonium acetate. More particularly, the novel salt form and crystalline hydrate form is useful for the treatment and prevention of diseases and conditions, such as metabolic syndrome, obesity, NASH, glycemic control/diabetes, and IBD (intestinal bowel disease).
Claims22
A denatonium acetate monohydrate salt of structural formula 1:
A process for preparing a denatonium acetate salt, comprising the steps of (1) contacting an equivalent of anhydrous denatonium acetate with methyl isobutyl ketone and water such that the water concentration is above 10 weight percent, (2) recovering a resultant solid phase, and (3) removing the solid phase therefrom.
A process for preparing a denatonium acetate salt, comprising contacting anhydrous denatonium acetate with a lower alkyl isobutyl ketone and water, resulting in formation of a solid phase comprising denatonium acetate monohydrate.
Dependencies are inferred from the claim text.