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Oxaprozin | CAS No: 21256-18-8 | GMP-certified suppliers
A medication that relieves inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis and osteoarthritis through non-narcotic, non-steroidal anti-inflammatory action.
Therapeutic categories
Primary indications
- Used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis and osteoarthritis
Product Snapshot
- Oxaprozin is available as oral capsules and various tablet formulations including film-coated and coated tablets
- It is primarily used for the management of inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis and osteoarthritis
- Oxaprozin is approved for use in Canada and the United States
Clinical Overview
Pharmacodynamically, Oxaprozin exhibits analgesic, anti-inflammatory, and antipyretic properties. Its mechanism of action involves non-selective inhibition of cyclooxygenase (COX) enzymes, with a higher affinity for COX-1 relative to COX-2. This inhibition reduces prostaglandin synthesis, a key mediator of inflammation and pain. The antipyretic effect is thought to arise from hypothalamic action, promoting peripheral vasodilation and heat dissipation.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics include predominant renal elimination, necessitating caution in patients with impaired renal function. Oxaprozin’s non-selective COX inhibition is associated with adverse effects related to gastrointestinal toxicity, nephrotoxicity, and potential inadvertent photosensitivity. Additionally, it may contribute to hypertension and hyperkalemia, thus requiring careful monitoring in at-risk populations.
Commonly used under various brand names globally, Oxaprozin remains an established option within the NSAID therapeutic class, though usage patterns may vary by region and regulatory approvals.
From an API sourcing perspective, quality control should focus on ensuring compliance with pharmacopeial standards covering purity, polymorphic form, and residual solvents. Given its physicochemical properties and therapeutic importance, consistent batch-to-batch quality and impurity profiling are critical to support formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Oxaprozin |
|---|---|
| Molecule type | Small molecule |
| CAS | 21256-18-8 |
| UNII | MHJ80W9LRB |
| DrugBank ID | DB00991 |
Pharmacology
| Summary | Oxaprozin is a non-selective NSAID that exerts anti-inflammatory, analgesic, and antipyretic effects primarily through inhibition of cyclooxygenase enzymes COX-1 and COX-2, leading to reduced prostaglandin synthesis. Its mechanism involves suppression of prostaglandin G/H synthase activity, which decreases inflammation and pain associated with rheumatoid arthritis and osteoarthritis. Antipyretic action may involve modulation of hypothalamic pathways resulting in vasodilation and heat dissipation. |
|---|---|
| Mechanism of action | Anti-inflammatory effects of Oxaprozin are believed to be due to inhibition of cylooxygenase in platelets which leads to the blockage of prostaglandin synthesis. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation. Oxaprozin is a non-selective NSAID, with a cell assay system showing lower COX-2 selectivity implying higher COX-1 selectivity. |
| Pharmacodynamics | Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Oxaprozin is used to treat rheumatoid arthritis, osteoarthritis, dysmenorrhea, and to alleviate moderate pain. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
ADME / PK
| Absorption | Oxaprozin is 95% absorbed after oral administration. Food may reduce the rate of absorption of oxaprozin, but the extent of absorption is unchanged. Antacids do not significantly affect the extent and rate of oxaprozin absorption. |
|---|---|
| Half-life | 54.9 hours |
| Protein binding | >99.5% bound to albumin |
| Metabolism | Hepatic. Ester and ether glucuronide are the major conjugated metabolites of oxaprozin, and do not have significant pharmacologic activity. |
| Route of elimination | Oxaprozin is expected to be excreted in human milk based on its physical-chemical properties; however, the amount of oxaprozin excreted in breast milk has not been evaluated. Approximately 95% of oxaprozin is metabolized by the liver. Approximately 5% of the oxaprozin dose is excreted unchanged in the urine. Sixty-five percent (65%) of the dose is excreted in the urine and 35% in the feces as metabolite. Biliary excretion of unchanged oxaprozin is a minor pathway. Several oxaprozin metabolites have been identified in human urine or feces. |
| Volume of distribution | * 11 to 17 L/70 kg |
Formulation & handling
- Oxaprozin is a small molecule indicated for oral administration, typically in capsule or tablet form.
- Food intake decreases the rate but not the extent of absorption; dosing after meals is recommended to manage tolerability.
- Due to low water solubility and moderate lipophilicity (LogP 3.46), formulation strategies should consider solubility enhancement for bioavailability optimization.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patent in the United States expired in May 2017, indicating that the market is now open to generic competition in both the US and Canada. Products containing this API are currently in the mature phase of their lifecycle in these markets. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Oxaprozin is manufactured by multiple generic pharmaceutical companies, indicating a well-established generic supply base. Branded products are primarily available in the US and Canadian markets, with several brand names present. The key US patent expired in 2017, allowing for existing generic competition in these regions. |
|---|
Safety
| Toxicity | Oral, mouse: LD<sub>50</sub> = 1210 mg/kg; Oral, rabbit: LD<sub>50</sub> = 172 mg/kg; Oral, rat: LD<sub>50</sub> = 4470 mg/kg |
|---|
- Handle with appropriate protective equipment to avoid ingestion and minimize exposure, given variable oral toxicity across species
- Use in well-ventilated areas to reduce inhalation risk due to potential systemic effects
- Store securely to prevent accidental ingestion, noting lower LD50 values in rabbits indicating higher sensitivity
Oxaprozin 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.
Oxaprozin (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.
Oxaprozin API manufacturers & distributors
Compare qualified Oxaprozin API suppliers worldwide. We currently have 2 companies offering Oxaprozin 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 |
|---|---|---|---|---|---|
| Cosma | Producer | Italy | Italy | CoA, GMP, USDMF | 20 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
When sending a request, specify which Oxaprozin 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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