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Auranofin | CAS No: 34031-32-8 | GMP-certified suppliers
A medication that treats active and progressive inflammatory arthritis, including adult rheumatoid arthritis, by providing anti-inflammatory and antirheumatic benefits for patients requiring second-line therapy.
Therapeutic categories
Primary indications
- Used in the treatment of active, progressive or destructive forms of inflammatory arthritis, such as adult rheumatoid arthritis
Product Snapshot
- Auranofin is an oral small molecule available in coated tablet and capsule formulations
- It is primarily indicated for the treatment of inflammatory arthritis, including adult rheumatoid arthritis
- Auranofin holds approved status in the US and Canada, with additional investigational uses
Clinical Overview
Pharmacodynamically, auranofin acts as a second-line therapeutic option, generally employed when first-line anti-inflammatory agents such as NSAIDs and corticosteroids fail to control disease progression. Its anti-inflammatory properties are mediated through suppression of immune cell activity and modulation of inflammatory pathways.
The precise mechanism of action in rheumatoid arthritis is not fully elucidated. However, auranofin inhibits phagocytosis and the release of antibodies and cytotoxic enzymes, which contribute to inflammation and tissue destruction in affected joints. Additionally, it induces the expression of heme oxygenase 1 (HO-1), an enzyme with anti-inflammatory effects through heme degradation.
Beyond its immunomodulatory activities, auranofin irreversibly inhibits thioredoxin reductase, an enzyme involved in cellular redox homeostasis. This inhibition increases oxidative stress and induces apoptosis in certain cells by elevating reactive oxygen species (ROS) and intracellular calcium levels. Such effects have garnered investigational interest in oncology, as thioredoxin reductase is often overexpressed in tumors.
Key absorption, distribution, metabolism, and excretion (ADME) data indicate that auranofin is primarily renally excreted. This characteristic necessitates caution in patients with impaired renal function. Safety considerations include potential toxicities associated with gold compounds, such as dermatological reactions, hematologic abnormalities, and nephrotoxicity. Monitoring for adverse effects is recommended during therapy.
Notable commercial formulations typically contain auranofin as a stable oral preparation, historically marketed under various brand names in rheumatology contexts.
For API sourcing, rigorous quality control is essential due to the compound’s organometallic nature. Specifications should ensure consistent purity, absence of heavy metal contaminants beyond acceptable limits, and stability. Suppliers must comply with Good Manufacturing Practice (GMP) standards and provide comprehensive documentation to support regulatory submissions.
Identification & chemistry
| Generic name | Auranofin |
|---|---|
| Molecule type | Small molecule |
| CAS | 34031-32-8 |
| UNII | 3H04W2810V |
| DrugBank ID | DB00995 |
Pharmacology
| Summary | Auranofin is a gold-containing compound used to reduce inflammation and joint damage in progressive inflammatory arthritis, including rheumatoid arthritis. Its pharmacological activity involves inhibition of immune cell functions such as phagocytosis and antibody release, suppressing the inflammatory response. Additionally, auranofin inhibits thioredoxin reductase, leading to increased oxidative stress and modulation of cellular redox homeostasis. |
|---|---|
| Mechanism of action | Inflammatory arthritis can cause joint swelling, warmth, pain, and tenderness; one cause of this condition is rheumatoid arthritis. In patients with rheumatoid arthritis, gold salts such as auranofin can be administered to decrease joint inflammation and prevent the destruction of bones and cartilage. Though the mechanism of action of auranofin is not fully established in rheumatoid arthritis, this drug has been shown to inhibit phagocytosis and the release of antibodies and enzymes that play a role in cytotoxic reactions, suppressing the inflammatory response. Aside from its probable immune effects in inflammatory arthritis, studies have shown that auranofin inhibits thioredoxin reductase. This enzyme has various roles in cell homeostasis, including the regulation of free radicals. Thioredoxin reductase can be over expressed in various types of tumours, rendering it an attractive target for anticancer drug development. Studies have shown that inhibiting thioredoxin reductase can cause oxidative stress and apoptosis of tumour cells by increasing the formation of free radicals. Aurofin's thiol ligand binds with high affinity to thiol and selenol groups, forming irreversible reaction products. One study showed that treatment with auranofin increased the production or reactive oxygen species and caused elevation of intracellular calcium concentration in platelets, leading to cell death. Another study showed that auranofin enhanced the production of free radicals, governing T-cell activation. |
| Pharmacodynamics | Auranofin is a gold salt used in treating inflammatory arthritis. Gold salts are called second-line drugs because they are often considered when the arthritis progresses in spite of antiinflammatory drugs (NSAIDs and corticosteroids). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peroxiredoxin-5, mitochondrial | Humans | inhibitor |
| Inhibitor of nuclear factor kappa-B kinase subunit beta | Humans | inhibitor |
ADME / PK
| Route of elimination | Approximately 60% of the absorbed gold (15% of the administered dose) from a single dose of auranofin is excreted in urine; the remainder is excreted in the feces. |
|---|
Formulation & handling
- Auranofin is administered orally and formulated as coated tablets or capsules.
- The molecule exhibits low water solubility and a negative LogP, indicating hydrophilic properties.
- It is recommended to administer with food to reduce gastrointestinal irritation associated with the compound.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient has patent protection expiring in the US and Canada within the next two years, with multiple products currently marketed in both regions. Post-patent expiration, the API is expected to enter a mature phase characterized by increased generic competition. |
|---|
| Markets | US, Canada |
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Supply Chain
| Supply chain summary | Auranofin is primarily manufactured by a single originator company, with packaging handled by multiple suppliers. Its branded product, Ridaura, is marketed mainly in the US and Canadian markets. Given the mature presence of the brand and absence of recent patents, there is likely existing generic competition in these regions. |
|---|
Safety
| Toxicity | Oral, rat: LD<sub>50</sub> = > 2000 mg/kg. Symptoms of overdose may include diarrhoea, vomiting, abdominal cramps, and symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). |
|---|
- Oral LD50 in rats is greater than 2000 mg/kg, indicating low acute toxicity
- Overdose symptoms may include gastrointestinal disturbances and hypersensitivity reactions
- Handle with appropriate protective equipment to avoid skin contact and inhalation exposure
Auranofin is a type of Indifferent resources
Indifferent resources, in the context of pharmaceutical active pharmaceutical ingredients (APIs), refer to the subcategory of materials used in the manufacturing process that do not react with or significantly affect the chemical properties of the API. These resources play a crucial role in ensuring the purity and stability of the final pharmaceutical product.
Indifferent resources include solvents, excipients, catalysts, and other auxiliary substances used during API synthesis or formulation. They are carefully selected to have minimal reactivity with the API, preserving its chemical integrity and therapeutic efficacy. The choice of indifferent resources depends on factors such as the API's chemical structure, solubility, and stability requirements.
By employing indifferent resources, pharmaceutical manufacturers can mitigate the risk of unwanted chemical reactions or degradation during the production and storage of APIs. This, in turn, enhances the quality and reliability of the pharmaceutical product.
In the pharmaceutical industry, the selection and use of indifferent resources are critical in complying with regulatory guidelines and ensuring the safety and efficacy of medications. Manufacturers must adhere to Good Manufacturing Practices (GMP) and perform comprehensive compatibility studies to identify suitable indifferent resources for their specific APIs.
Overall, indifferent resources serve as indispensable components in the pharmaceutical API manufacturing process, guaranteeing the production of high-quality, stable, and safe medications that meet stringent regulatory standards.
Auranofin (Indifferent resources), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Auranofin API manufacturers & distributors
Compare qualified Auranofin API suppliers worldwide. We currently have 2 companies offering Auranofin API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Medichem | Producer | Spain | Unknown | CoA, JDMF | 39 products |
When sending a request, specify which Auranofin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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