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Tolmetin | CAS No: 26171-23-3 | GMP-certified suppliers
A medication that provides anti-inflammatory and analgesic effects for managing rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis, supporting both acute flare relief and long-term treatment.
Therapeutic categories
Primary indications
- For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, including the treatment of acute flares long-term management
- Also for treatment of juvenile rheumatoid arthritis
Product Snapshot
- Tolmetin is available as an oral small molecule in capsules and film-coated tablets
- It is primarily used for the management of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis
- Tolmetin is approved for marketing in Canada and the United States
Clinical Overview
Pharmacologically, tolmetin exhibits anti-inflammatory, analgesic, and antipyretic effects. Its mechanism of action involves inhibition of prostaglandin synthetase, leading to decreased plasma levels of prostaglandin E. This reduction in prostaglandin synthesis is considered responsible for its anti-inflammatory properties. Tolmetin does not appear to modify the progression of underlying disease processes but effectively controls inflammation and associated symptoms.
Clinical studies demonstrate that tolmetin is comparably effective to aspirin and indomethacin in reducing disease activity in rheumatoid and osteoarthritis patients, with a more favorable tolerability profile. Notably, gastrointestinal adverse effects and tinnitus are reported less frequently than with aspirin, while central nervous system adverse effects are less common than with indomethacin. In juvenile rheumatoid arthritis, tolmetin shows efficacy comparable to aspirin with a similar safety profile. It may be combined with gold salts or corticosteroids for additional therapeutic benefit but should not be used concomitantly with salicylates due to an increased risk of adverse reactions without added efficacy.
Pharmacokinetic and absorption-distribution-metabolism-excretion (ADME) data for tolmetin indicate oral bioavailability consistent with NSAIDs, although specific parameters vary with formulation and patient factors. Tolmetin is recognized to have potential safety concerns typical of non-selective COX inhibitors, including nephrotoxicity, hypertension, and risk of hyperkalemia, necessitating caution in patients with relevant comorbidities.
From a regulatory perspective, tolmetin is approved in multiple markets and categorized under acetic acid derivative NSAIDs with non-selective cyclooxygenase inhibition. It is available in various formulations targeting musculoskeletal indications.
When sourcing tolmetin API, attention to purity, impurity profiles, and compliance with pharmacopeial standards is critical to ensure safety and efficacy in finished dosage forms. Reliable suppliers should provide documentation verifying adherence to current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
Identification & chemistry
| Generic name | Tolmetin |
|---|---|
| Molecule type | Small molecule |
| CAS | 26171-23-3 |
| UNII | D8K2JPN18B |
| DrugBank ID | DB00500 |
Pharmacology
| Summary | Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin G/H synthase 1 and 2, leading to reduced prostaglandin E synthesis. It exerts anti-inflammatory, analgesic, and antipyretic effects primarily through prostaglandin synthesis inhibition. Tolmetin is indicated for managing symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. |
|---|---|
| Mechanism of action | The mode of action of tolmetin is not known. However, studies in laboratory animals and man have demonstrated that the anti-inflammatory action of tolmetin is not due to pituitary-adrenal stimulation. Tolmetin inhibits prostaglandin synthetase in vitro and lowers the plasma level of prostaglandin E in man. This reduction in prostaglandin synthesis may be responsible for the anti-inflammatory action. Tolmetin does not appear to alter the course of the underlying disease in man. |
| Pharmacodynamics | Tolmetin is a nonsteroidal anti-inflammatory agent. Studies in animals have shown tolmetin to possess anti-inflammatory, analgesic and antipyretic activity. In the rat, tolmetin prevents the development of experimentally induced polyarthritis and also decreases established inflammation. In patients with either rheumatoid arthritis or osteaoarthritis, tolmetin is as effective as aspirin and indomethacin in controlling disease activity, but the frequency of the milder gastrointestinal adverse effects and tinnitus was less than in aspirin-treated patients, and the incidence of central nervous system adverse effects was less than in indomethacin-treated patients. In patients with juvenile rheumatoid arthritis, tolmetin is as effective as aspirin in controlling disease activity, with a similar incidence of adverse reactions. tolmetin has produced additional therapeutic benefit when added to a regimen of gold salts and, to a lesser extent, with corticosteroids. Tolmetin should not be used in conjunction with salicylates since greater benefit from the combination is not likely, but the potential for adverse reactions is increased. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Rapidly and almost completely absorbed with peak plasma levels being reached within 30-60 minutes after an oral therapeutic dose. |
|---|---|
| Half-life | Biphasic elimination from the plasma consisting of a rapid phase with a half-life of one to 2 hours followed by a slower phase with a half-life of about 5 hours. |
| Metabolism | Essentially all of the administered dose is recovered in the urine in 24 hours either as an inactive oxidative metabolite or as conjugates of tolmetin. |
Formulation & handling
- Tolmetin is administered orally in solid dosage forms such as capsules and tablets, with no injectable formulations reported.
- As a small molecule NSAID, Tolmetin exhibits moderate lipophilicity (LogP 2.73) and limited aqueous solubility, requiring appropriate formulation strategies for consistent bioavailability.
- Food intake can reduce Tolmetin bioavailability by up to 50%, although administration with food may mitigate gastrointestinal irritation; alcohol co-ingestion should be avoided due to increased GI risks.
Regulatory status
| Lifecycle | The API is available in the US and Canadian markets with patent protection expired, leading to the presence of multiple generic formulations. Market maturity is characterized by established competition and stabilized pricing. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Tolmetin is manufactured by multiple companies, including original and generic drug manufacturers, indicating an established supply base with diverse production sources. Branded products are primarily present in the US and Canadian markets, with several formulations available under different brand names. Patent expiry has led to existing generic competition, reflected in a broad range of generic manufacturers and packagers active in the market. |
|---|
Safety
| Toxicity | Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain. |
|---|
- Overdose may result in central nervous system depression manifesting as lethargy and drowsiness
- Gastrointestinal symptoms such as nausea, vomiting, and epigastric pain have been reported with excessive exposure
- Handling should minimize exposure to prevent adverse systemic effects associated with overdose
Tolmetin is a type of NSAIDs
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are a widely used subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs). These medications are commonly prescribed for their analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. NSAIDs work by inhibiting the production of certain enzymes called cyclooxygenases (COX), which play a crucial role in the synthesis of prostaglandins, substances that contribute to pain, inflammation, and fever.
These pharmaceutical APIs are available in various formulations, including tablets, capsules, creams, and gels, making them convenient for different administration routes. Some popular examples of NSAIDs include aspirin, ibuprofen, naproxen, and diclofenac.
NSAIDs are commonly used to treat a wide range of conditions such as arthritis, musculoskeletal injuries, dental pain, menstrual pain, and headaches. They are also effective in managing inflammatory conditions like rheumatoid arthritis and ankylosing spondylitis.
While NSAIDs are generally safe and effective when used as directed, they may have side effects. These can include gastrointestinal issues such as stomach ulcers or bleeding, cardiovascular risks, and kidney problems. Therefore, it is essential to follow the recommended dosage and consult with healthcare professionals to ensure proper and safe usage.
In conclusion, NSAIDs are a subcategory of pharmaceutical APIs that offer analgesic, anti-inflammatory, and antipyretic properties. Their versatility and effectiveness in treating various conditions make them widely prescribed medications. However, it is crucial to be aware of potential side effects and consult healthcare providers for appropriate usage.
Tolmetin (NSAIDs), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Tolmetin API manufacturers & distributors
Compare qualified Tolmetin API suppliers worldwide. We currently have 1 companies offering Tolmetin API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
When sending a request, specify which Tolmetin 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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