L-ORNITHINE PHENYL ACETATE AND METHODS OF MAKING THE SAME

摘要

PROBLEM TO BE SOLVED: To provide compositions formulated for treating subjects with liver disorders such as hepatic encephalopathy caused by hyperammonemia, and methods of making salts included in the compositions.SOLUTION: A composition comprises at least about 50 wt.% of a crystalline form of an L-ornithine phenyl acetate salt and at least about 0.01 wt.% of benzoic acid or a salt thereof. A method for making the L-ornithine phenyl acetate salt comprises: intermixing an L-ornithine salt, a benzoate salt and a solvent to form an intermediate solution; intermixing phenyl acetate with the intermediate solution; and isolating a composition comprising at least 70 wt.% of crystalline L-ornithine phenyl acetate.