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Phenylacetic acid API Manufacturers & Suppliers
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Phenylacetic acid | CAS No: 103-82-2 | GMP-certified suppliers
A medication that supports adjunctive treatment of acute hyperammonemia and encephalopathy in patients with urea cycle enzyme deficiencies by facilitating nitrogen excretion.
Therapeutic categories
Primary indications
- For use as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle
Product Snapshot
- Phenylacetic acid is available as an injectable solution formulated for intravenous administration
- It is used as adjunctive therapy in the management of acute hyperammonemia and related encephalopathy linked to urea cycle enzyme deficiencies
- The product is approved for use in the US market
Clinical Overview
Clinically, phenylacetic acid is used as an adjunctive therapeutic agent in the management of acute hyperammonemia and related encephalopathy, particularly in patients with inherited deficiencies in enzymes of the urea cycle. These enzyme defects impair the body's ability to eliminate excess nitrogen, leading to toxic accumulation of ammonia. Phenylacetic acid contributes to nitrogen scavenging, facilitating alternative pathways for nitrogen excretion.
Although detailed pharmacodynamics and mechanism of action data are not specified, phenylacetic acid acts as a nitrogen-binding agent. It forms conjugates with amino acids such as glutamine, enabling removal of nitrogen through renal excretion and thereby reducing plasma ammonia concentrations.
Key ADME (absorption, distribution, metabolism, and excretion) parameters for phenylacetic acid are not extensively documented in the public domain. Its primary clinical utility involves systemic circulation and renal clearance post-administration.
Safety considerations include the potential for toxicity related to its nitrogen scavenging effects, necessitating careful dosing and monitoring in affected patients. Additionally, phenylacetic acid is subject to regulatory control in multiple jurisdictions due to its use as a precursor in the illicit synthesis of phenylacetone, a key intermediate in amphetamine production. Consequently, handling and distribution are regulated, including in countries such as the United States and China.
Phenylacetic acid is marketed under various formulations intended for use in urea cycle disorder management. When sourcing phenylacetic acid as an active pharmaceutical ingredient (API), stringent quality control measures are essential. This includes verification of purity, compliance with regulatory restrictions, and assurance of supply chain integrity due to its dual-use potential and controlled status in many countries.
Identification & chemistry
| Generic name | Phenylacetic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 103-82-2 |
| UNII | ER5I1W795A |
| DrugBank ID | DB09269 |
ADME / PK
| Metabolism | Phenylacetate esterases found in the human liver cytosol. Human plasma esterase also hydrolyze phenylacetate. Phenylacetate hydrolysis involved arylesterase in plasma, both arylesterase and carboxylesterase in liver microsomes and carboxylesterase in liver cytosol. Plasma hydrolysis is less important and overall esterase activity is lower in humans than in the rat. |
|---|---|
| Volume of distribution | 19.2 ± 3.3 L. |
Formulation & handling
- Phenylacetic acid is a small molecule suitable for intravenous injection formulations.
- Moderate water solubility and LogP indicate balanced hydrophilic-lipophilic properties relevant for solution stability.
- Handling should consider its aromatic acid nature; maintain appropriate pH to ensure chemical stability in injectable forms.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) entered the US market following patent expiry in , leading to the availability of multiple generic formulations and increased market competition. The product is currently established with a mature market presence in the US. |
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| Markets | US |
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Supply Chain
| Supply chain summary | The manufacturing landscape for phenylacetic acid involves multiple originator companies supplying branded formulations such as Ammonul and Sodium Phenylacetate combinations, primarily in the US market. These products have established a presence mainly within North America, with limited indication of global distribution. Patent expirations indicate the potential or presence of generic competition, supporting broader availability through alternative suppliers. |
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Safety
| Toxicity | Acute oral toxicity (LD50): 2250 mg/kg [Mouse]. |
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- Handle with appropriate personal protective equipment to avoid ingestion and minimize exposure
- Toxicity studies indicate an acute oral LD50 of 2250 mg/kg in mice
- Avoid accidental ingestion
Phenylacetic acid is a type of Other antibacterials
The category of pther antibacterials in the pharmaceutical API (Active Pharmaceutical Ingredient) industry encompasses a diverse range of antibacterial substances that are not classified under specific subcategories. These APIs exhibit potent antibacterial activity against various bacteria and play a crucial role in combating bacterial infections.
The Other antibacterials category includes several subclasses of pharmaceutical APIs, such as nitroimidazoles, fusidanes, polymyxins, and glycopeptides. Each subclass comprises specific chemical compounds that target different types of bacteria through distinct mechanisms of action.
Nitroimidazoles are effective against anaerobic bacteria and protozoa by interfering with their DNA replication. They are commonly used in the treatment of infections in the gastrointestinal tract, pelvic area, and respiratory system. Fusidanes, on the other hand, inhibit bacterial protein synthesis and are particularly active against Gram-positive bacteria. They find application in treating skin and soft tissue infections caused by Staphylococcus aureus.
Polymyxins are cyclic peptides that disrupt the integrity of bacterial cell membranes, rendering them inactive. These APIs are potent against Gram-negative bacteria and are often reserved for multidrug-resistant strains.
Glycopeptides, such as vancomycin, are essential for combating Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA). They inhibit bacterial cell wall synthesis, leading to bacterial death.
The Other antibacterials category plays a critical role in providing effective treatment options for bacterial infections, particularly when other classes of antibacterials have shown limited efficacy. Pharmaceutical companies continually explore and develop new compounds within this category to address emerging antibiotic resistance and enhance patient care.
