L-ornithine phenyl acetate and methods of making thereof
AssigneeAmalive Limited
InventorsKeith Anderson, Jim Behling, Christine Henderson Dougan, Stephen William Watt, Peter Manini, Attilia Figini
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Abstract
Disclosed herein are forms of L-ornithine phenyl acetate and methods of making the same. A crystalline form may, in some embodiments, be Forms I, II, III and V, or mixtures thereof. The crystalline forms may be formulated for treating subjects with liver disorders, such as hepatic encephalopathy. Accordingly, some embodiments include formulations and methods of administering L-ornithine phenyl acetate.
Claims17
An amorphous form of L-ornithine phenylacetate, prepared by a process comprising:
- intermixing an L-ornithine salt, a benzoate salt and a solvent to form an intermediate solution;
- intermixing phenylacetate with said intermediate solution;
- and
- isolating a composition comprising at least 70% by weight of the amorphous form of L-ornithine phenylacetate, wherein the composition comprises at least about 0.1% by weight benzoate salt.
An amorphous form of L-ornithine phenylacetate, prepared by a process comprising:
- increasing the pH value of a solution comprising an L-ornithine salt at least until an intermediate salt precipitates, wherein said intermediate salt is not an L-ornithine salt;
- isolating the intermediate salt from said solution;
- intermixing phenyl acetic acid with said solution;
- and
- isolating a composition comprising an amorphous form of L-ornithine phenylacetate from said solution, wherein the L-ornithine phenylacetate salt is L-ornithine hydrochloride, and wherein the composition comprises at least about 0.005% by weight of chloride.
Dependencies are inferred from the claim text.