Antiinflammatory Drug APIs
Premium NSAID Active Pharmaceutical Ingredients for Inflammation and Pain Management
About Antiinflammatory Drug APIs
Holiness Pharmaceutical manufactures and exports high-quality Antiinflammatory Drug APIs, specifically Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used for pain, fever, and inflammation management. Our portfolio includes oxicam-class and other NSAIDs manufactured under WHO-GMP standards. We serve pharmaceutical companies worldwide, providing APIs for developing effective antiinflammatory medications that improve patient mobility and quality of life.
Key Features
- WHO-GMP certified NSAID manufacturing facility
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Various NSAID classes with different mechanisms
- Advanced synthesis and crystallization technology
- Polymorphic form control for optimal bioavailability
- Comprehensive genotoxic impurity control
- Complete regulatory documentation and DMF support
- Technical support for sustained-release formulations
Application Areas
Rheumatoid Arthritis
Long-term management of joint inflammation and pain in autoimmune arthritis
Osteoarthritis
Treatment of degenerative joint disease and chronic pain
Acute Musculoskeletal Pain
Relief from strains, sprains, and soft tissue injuries
Post-Operative Pain
Pain and inflammation management following surgical procedures
Ankylosing Spondylitis
Management of spinal inflammation and related conditions
Quality Assurance
Our antiinflammatory drug APIs undergo comprehensive quality testing including HPLC analysis for purity and related substances, polymorphic form characterization using XRD and DSC, particle size distribution analysis, residual solvent testing, genotoxic impurity screening, heavy metal analysis, and thorough microbiological evaluation. Each batch meets stringent specifications for chronic inflammatory disease treatment.
Our Antiinflammatory Drug APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Piroxicam API | 36322-90-4 | IP/BP/USP | API Powder | View Product |
Frequently Asked Questions
What are Antiinflammatory Drug APIs?
Antiinflammatory Drug APIs are active pharmaceutical ingredients, primarily NSAIDs, that reduce inflammation, relieve pain, and lower fever by inhibiting cyclooxygenase (COX) enzymes. They include various classes such as oxicams (piroxicam), which have long half-lives suitable for once-daily dosing in chronic inflammatory conditions.
Which antiinflammatory drug APIs does Holiness Pharmaceutical manufacture?
We manufacture Piroxicam (oxicam-class NSAID) and related antiinflammatory agents to IP, BP, and USP standards. Piroxicam has a long half-life (40-50 hours) making it particularly suitable for once-daily treatment of chronic inflammatory conditions like rheumatoid arthritis and osteoarthritis.
What makes Piroxicam suitable for chronic inflammatory conditions?
Piroxicam has an exceptionally long half-life allowing once-daily dosing, which improves patient compliance in chronic conditions. It provides sustained anti-inflammatory effect, has potent COX inhibition, accumulates in inflamed tissues, and maintains steady plasma levels. These properties make it ideal for long-term management of arthritis.
How do you control polymorphic forms in NSAID APIs?
We maintain strict control over crystallization conditions including temperature, solvent selection, seeding, and cooling rates. Each batch undergoes polymorphic characterization using X-Ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), and infrared spectroscopy. Consistent polymorphic form ensures reproducible dissolution, bioavailability, and therapeutic effect.
Can you provide specifications for sustained-release formulations?
Yes, we offer specifications optimized for sustained-release formulations including controlled particle size distribution, specific polymorphic forms with appropriate dissolution characteristics, and low moisture content. For drugs like Piroxicam with long half-lives, sustained-release formulations can further improve tolerability by reducing peak plasma concentrations.
How do you address gastrointestinal safety concerns with NSAIDs?
While API manufacturers cannot eliminate NSAID GI risks, we ensure consistent quality and purity, provide technical support for enteric coating and gastroprotective formulations, offer appropriate particle sizes for modified release, and supply impurity profiles showing absence of irritating contaminants. Proper formulation design can significantly reduce GI side effects.
Do you test for genotoxic impurities in NSAID APIs?
Yes, we conduct comprehensive genotoxic impurity assessments following ICH M7 guidelines. Our analytical methods include sensitive techniques to detect and quantify potential genotoxic impurities below acceptable limits. This is particularly important for NSAIDs used chronically, ensuring long-term patient safety.
What is the typical shelf life of antiinflammatory drug APIs?
Most antiinflammatory drug APIs have a shelf life of 2-3 years when stored properly in tightly closed containers protected from light and moisture at controlled temperature (15-25°C). We provide comprehensive stability data under ICH guidelines supporting the assigned shelf life. Since these treat chronic conditions, long-term stability is critical.