Procedure for the preparation of 4-phenyl butyrate and uses thereof
Provided is a process for preparing 4-phenyl-1-butyric acid, comprising: reacting 4-phenyl-1-butanol with sodium chlorite, a nitroxyl radical catalyst and sodium hypochlorite in an organic solvent and a phosphate buffer; and quenching the reaction with sodium sulfite to produce 4-phenyl-1-butyric. Also provided is 4-phenyl-1-butyric acid prepared by such a process.
1. A pharmaceutical composition consisting of glycerol triphenylbutyrate having the structure:
wherein the glycerol triphenylbutyrate has a purity that is greater than about 99% by high performance liquid chromatography (HPLC) analysis,
less than 0.1% of any single individual impurity w/w as measured by area percentage of HPLC; and
less than 0.04% 3-benzoyl propionic acid w/w as measured by area percentage of HPLC.
2. A method of treating a patient with a nitrogen retention disorder, comprising administering to the patient the pharmaceutical composition of claim 1 .
3. The method of claim 2 , wherein the nitrogen retention disorder is a urea cycle disorder.
4. The method of claim 2 , wherein the patient is a pediatric subject under the age of 12.
5. The method of claim 2 , wherein the composition is administered orally.
6. The method of claim 2 , wherein the composition is administered by nasogastric tube or gastrostomy tube.