Description
Diacerein & Glucosamine Sulphate Film-Coated Tablets (50 mg / 750 mg)
Healthy Inc is a specialized global supplier and exporter of advanced rheumatology, orthopedics, and targeted chondroprotective therapeutics. We provide ultra-high-purity, kinetically synchronized Diacerein & Glucosamine Sulphate Potassium Chloride Film-Coated Tablets (50 mg / 750 mg), manufactured in WHO–GMP certified, strictly humidity-controlled oral solid dosage facilities. This “IL-1β Inhibitor & Cartilage Substrate FDC” is a massive-volume, highly strategic export to orthopedic networks, physical therapy centers, geriatric clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, NSAID-sparing intervention for the long-term structural modification and symptom relief of Osteoarthritis.
Product Overview
This highly advanced formulation operates as a coordinated, two-front biochemical campaign to save the aging joint. Instead of merely masking the pain, it fundamentally alters the trajectory of the disease by paralyzing the enzymes that eat cartilage, while simultaneously flooding the joint with the raw building blocks needed for repair.
The “Chondroprotective & Disease-Modifying” Specialist:
- Mechanism 1 (The Catabolic Halt – Diacerein): In osteoarthritis, the immune system mistakenly floods the joint with Interleukin-1 beta (IL-1β), a highly destructive pro-inflammatory cytokine. IL-1β triggers the release of matrix metalloproteinases (enzymes that literally digest the cartilage). Diacerein (an anthraquinone derivative) specifically completely inhibits the production and activity of IL-1β. This violently halts the cartilage destruction process at its biological source, without interfering with prostaglandin synthesis (meaning it causes zero stomach ulcers).
- Mechanism 2 (The Anabolic Rebuilder – Glucosamine Sulphate): Glucosamine is a naturally occurring amino sugar. It is the fundamental, rate-limiting biological substrate required by the chondrocytes (cartilage cells) to synthesize glycosaminoglycans (GAGs) and proteoglycans—the molecules that give cartilage its elasticity and shock-absorbing power. Flooding the joint with high-purity Glucosamine stimulates the physical regeneration of the articular matrix.
- The “SYSADOA” Synergy: Known clinically as Symptomatic Slow-Acting Drugs for Osteoarthritis (SYSADOA), this combination does not provide instant pain relief. However, after 2 to 4 weeks of continuous therapy, it provides profound, long-lasting pain relief that persists for months even after the drug is stopped, massively reducing the patient’s reliance on dangerous, kidney-damaging NSAIDs.
Product Composition & Strength
We supply this product as a Precision-Blended, Hydrolytically Shielded Macrodose FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical survival of the intensely hygroscopic Glucosamine salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Diacerein USP/Ph.Eur. | 50 mg | The IL-1β Inhibitor: The potent, slow-acting anti-inflammatory anchor required to halt the enzymatic digestion of joint cartilage. |
| Glucosamine Sulphate Potassium Chloride USP/Ph.Eur. (Equivalent to Glucosamine Sulphate 750mg) | 750 mg | The Cartilage Substrate: The massive amino-sugar payload required to stimulate proteoglycan synthesis and rebuild the articular matrix. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Polymeric Film | Diluent / Superdisintegrant / Binder / Glidant / Heavy Film-Coating (Engineered specifically utilizing advanced Low-Humidity Granulation Technology to process the sticky, highly hygroscopic Glucosamine, sealed with a dense polymer film to block environmental moisture and ensure rapid gastric dissolution of the highly insoluble Diacerein) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, continuous, long-term chronic dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Orthopedic Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Orthopedics/Rheumatology) |
| CAS Numbers | 13739-02-7 (Diacerein) / 29031-19-4 (Glucosamine Sulphate) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-Alu Blisters (STRICTLY MANDATORY). Glucosamine Sulphate acts like a sponge for atmospheric moisture. If packaged in standard PVC, it will rapidly degrade and swell. Strict Alu-Alu barrier packaging guarantees absolute chemical stability and therapeutic potency across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hygroscopic Defense & Insoluble API Profiling (CRITICAL COMPLIANCE): Compressing this 800mg+ FDC is an extreme test of pharmaceutical engineering. Diacerein is notoriously insoluble—if not micronized properly, it will not absorb, and the unabsorbed powder will draw massive amounts of water into the colon, causing violent, explosive diarrhea. Our orthopedic suites utilize rigorous API micronization to maximize systemic absorption, while maintaining strict dehumidification (RH < 30%) to handle the Glucosamine. We guarantee global procurement boards a stable, highly tolerable formulation.
Therapeutic Indications (Human Use)
Indicated for the targeted, long-term structural management of degenerative joint disease:
- Osteoarthritis (Knee, Hip, and Spine): First-line, long-term management of pain, stiffness, and cartilage degradation associated with osteoarthritis.
- NSAID-Sparing Protocol: Utilized specifically to reduce or eliminate the patient’s reliance on gastro-toxic and nephrotoxic traditional painkillers.
Dosage & Administration
Recommended Dosage (Strictly as per Orthopedic Guidelines):
- Standard Adult Dosing: 1 tablet taken orally twice daily (BID).
- The “Food Mandate” & Diarrhea Control: MUST be taken immediately after a main meal. Taking Diacerein on an empty stomach drastically increases the rate of unabsorbed drug reaching the lower bowel, which acts as a powerful osmotic laxative and triggers severe diarrhea.
- The Patience Protocol: Patients must be explicitly counseled that this is not an instant painkiller. Full clinical benefits take 2 to 4 weeks of continuous daily use to manifest.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Hepatotoxicity Warning (Diacerein Alert): The European Medicines Agency (EMA) has issued strict warnings regarding severe liver injury linked to Diacerein. Liver enzymes (ALT/AST) must be monitored. It is strictly contraindicated in patients with current or prior liver disease.
- Severe Diarrhea & Dehydration: The most common and therapy-limiting side effect is severe, frequent diarrhea during the first two weeks. If diarrhea leads to dehydration, therapy must be stopped to protect the kidneys.
- Shellfish Allergy Contraindication (Glucosamine): Commercial Glucosamine is frequently synthesized from the chitin exoskeletons of crustaceans (crabs, shrimp). It is strictly contraindicated in patients with severe shellfish allergies due to the risk of anaphylaxis.
- Urine Discoloration (Harmless): Diacerein is an anthraquinone. It will turn the patient’s urine intensely yellow, brown, or red. Patients must be reassured that this is a harmless chemical clearance process, not hematuria (blood in the urine).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Orthopedic Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Chondroprotectants, DMOADs, and Hygroscopic FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for geriatric care clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.










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