BEHLING JIM,DOUGAN CHRISTINE HENDERSON,FIGINI ATTILIA,WATT STEPHEN WILLIAM,ANDERSON KEITH,MANINI PETER
申请号：
NZ61923510
公开号：
NZ619235A
申请日:
2010.04.01
申请国别(地区):
NZ
年份:
2015
代理人:
摘要：
Provided are processes for preparing crystalline L-ornithine phenyl acetate salts. One method of preparation involves intermixing an L-ornithine salt, a benzoate salt and a solvent to form an intermediate solution； intermixing phenyl acetate with the solution； and isolating a composition comprising at least 70% crystalline L-ornithine phenyl acetate by weight. A second method involves 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 an L-ornithine phenyl acetate salt from said solution. A third method involves intermixing an L-ornithine salt, silver phenyl acetate and a solvent to form a solution, wherein the L-ornithine salt is a halide salt. Further provided are crystalline L-ornithine phenyl acetate salts which may, in some embodiments, be of Form I, II, III or 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.
