Sodium Phenylbutyrate

(BAN, USAN)
Sodium Phenylbutyrate Chemical formula

💊 Chemical information

Fenilbutirato de sodio; Natrii phenylbutyras; Natriumfenylbutyrat; Natriumfenyylibutyraatti; Sodium, phénylbutyrate de; Sodyum Fenilbutirat. Sodium 4-Phenylbutyrate.
Chemical formula: C10H11NaO2 = 186.2.
CAS — 1716-12-7.
ATC — A16AX03.
ATC Vet — QA16AX03.

Pharmacopoeias.

In Eur..

Ph. Eur. 6.2

(Sodium Phenylbutyrate). A white or yellowishwhite powder. Freely soluble in water and in methyl alcohol; practically insoluble in dichloromethane. A 2% solution in water has a pH of 6.5 to 7.5.

💊 Profile

Sodium phenylbutyrate is a prodrug for sodium phenylacetate (see above) and is used as adjunctive treatment of hyperammonaemia in patients with urea cycle disorders. It is given orally in equally divided doses with meals. The total daily dose for patients weighing under 20 kg is 450 to 600 mg/kg, and for those weighing over 20 kg, 9.9 to 13.0 g/m2. Sodium phenylbutyrate is also under investigation for the treatment of some sickle-cell disorders and for use as a potential differentiation-inducing agent in malignant glioma and acute myeloid leukaemia. Sodium phenylbutyrate is also under investigation for spinal muscular atrophy, which is caused by homozygous absence of the SMN1 gene, after reports that it significantly increased SMN transcript expression in both fibroblast cultures and leucocytes from these patients.
1. Batshaw ML, et al. Alternative pathway therapy for urea cycle disorders: twenty years later. J Pediatr 2001; 138 (suppl 1): S46–S55. Correction. ibid. 2002; 140: 490
2. Mercuri E, et al. Randomized, double-blind, placebo-controlled trial of phenylbutyrate in spinal muscular atrophy. Neurology 2007; 68: 51–5
3. Caruthers RL, Johnson CE. Stability of extemporaneously prepared sodium phenylbutyrate oral suspensions. Am J Health-Syst Pharm 2007; 64: 1513–15.

💊 Preparations

Proprietary Preparations

Cz.: Ammonaps; Fr.: Ammonaps†; Ger.: Ammonaps†; Ital.: Ammonaps; Neth.: Ammonaps; Pol.: Ammonaps; Port.: Ammonaps; Spain: Ammonaps; UK: Ammonaps; USA: Buphenyl.
Published May 08, 2019.