Description

Sulfasalazine Enteric-Coated Tablets (500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced rheumatological, gastroenterological, and autoimmune therapeutics. We provide ultra-high-purity, kinetically targeted Sulfasalazine Delayed-Release (Enteric-Coated) Tablets (500 mg), manufactured in WHO–GMP certified, high-precision modified-release facilities. This “Dual-Action DMARD & Anti-Inflammatory Prodrug” is a massive-volume, essential export to rheumatology centers, gastroenterology clinics, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, foundational intervention for Rheumatoid Arthritis and Ulcerative Colitis.

Product Overview

This formulation contains Sulfasalazine, a brilliant pharmaceutical “prodrug” that harnesses the body’s own colonic bacteria to deliver targeted therapy precisely where the inflammation is occurring.

The “Colonic Cleavage & Immunomodulatory” Specialist:

• Mechanism 1 (The Bacterial Cleavage): Sulfasalazine is a combination of an antibiotic (sulfapyridine) and an anti-inflammatory (5-aminosalicylic acid, or 5-ASA), linked together by a chemical azo bond. When swallowed, it travels intact through the stomach and small intestine. Once it reaches the colon, resident bacterial enzymes (azoreductases) break the bond, releasing the two active components directly into the disease site.
• Mechanism 2 (IBD & Rheumatology Synergy): Once cleaved, the 5-ASA remains primarily in the colon, exerting a powerful, localized topical anti-inflammatory effect to heal the bleeding ulcers of Ulcerative Colitis. Conversely, the Sulfapyridine component is absorbed into the bloodstream, where it acts as a systemic Disease-Modifying Antirheumatic Drug (DMARD), suppressing the overactive immune system to halt joint destruction in Rheumatoid Arthritis.
• The Enteric-Coated Imperative: Immediate-release sulfasalazine frequently causes severe, debilitating nausea and gastric distress. Our advanced Delayed-Release (Enteric-Coated) tablets utilize pH-sensitive methacrylic polymers to completely bypass the acidic stomach, only dissolving in the alkaline environment of the lower intestines. This drastically reduces gastrointestinal side effects and ensures perfect patient compliance for chronic therapy.

Product Composition & Strength

We supply this product as a Precision-Engineered Enteric-Coated Film Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute stability of the pH-sensitive polymer matrix.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict chronic autoimmune adherence regimens where patients consume multiple grams daily).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Rheumatology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Advanced Enteric Polymer Coating: Coating a large 500 mg tablet with a flawless, uniform enteric layer requires elite pharmaceutical engineering. Our facilities utilize advanced Fluid Bed Processors or Auto-Coaters to apply precise layers of Methacrylic Acid Copolymers. This is verified by rigorous two-stage dissolution testing (acid stage followed by buffer stage) to guarantee the tablet absolutely will not dissolve in stomach acid, preventing premature release and localized gastric toxicity.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe autoimmune and inflammatory disease:

• Rheumatoid Arthritis (RA): Treatment of adult patients with rheumatoid arthritis who have responded inadequately to salicylates or other NSAIDs (often used as part of triple DMARD therapy).
• Ulcerative Colitis (UC): Treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis. Maintenance therapy to prolong the period of remission.
• Juvenile Rheumatoid Arthritis: Treatment of pediatric patients with polyarticular-course JRA.

Dosage & Administration

Recommended Dosage (Strictly as per Specialist Guidelines):

• Standard Adult Dosing (RA & UC): Dosing is highly individualized. Therapy typically initiates at 500 mg to 1000 mg daily, slowly titrating up to a maintenance dose of 2000 mg (2 grams) to 3000 mg per day, given in evenly divided doses.
• Administration (THE WATER RULE): Tablets should be taken after meals with a full glass of water. Adequate fluid intake is mandatory to prevent crystalluria and kidney stone formation.
• Swallowing Protocol (CRITICAL HAZARD): The tablet MUST be swallowed whole. It must never be crushed, chewed, or divided. Breaking the tablet destroys the enteric coating, unleashing severe gastric distress and nausea.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Sulfa Allergy Contraindication: Sulfasalazine contains a sulfonamide moiety. It is strictly contraindicated in patients with a known hypersensitivity to sulfa drugs, salicylates (like Aspirin), or other loop diuretics.
• Blood Dyscrasias (BLACK BOX EQUIVALENT): Can cause severe, potentially fatal blood disorders, including agranulocytosis, aplastic anemia, and thrombocytopenia. Complete Blood Counts (CBC) and liver function tests must be performed prior to starting therapy and every second week during the first three months of therapy.
• Urine & Skin Discoloration (Patient Counseling): The drug will harmlessly color the urine, sweat, and tears orange-yellow. Patients must be warned to prevent panic, and advised that it may permanently stain soft contact lenses.
• Reversible Oligospermia: Frequently causes a temporary, profound drop in sperm count (oligospermia) and infertility in men. This reverses completely within 2 to 3 months of stopping the medication.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterological and Autoimmune Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for IBD programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.