Description

Mesalazine (Mesalamine) Prolonged-Release Tablets (400 mg / 800 mg / 1200 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology, auto-immune, and targeted drug-delivery therapeutics. We provide ultra-high-purity, kinetically stabilized Mesalazine Prolonged-Release (PR) Film-Coated Tablets (400 mg / 800 mg / 1200 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Locally-Acting Intestinal Anti-Inflammatory” is an ultra-high-value, highly lucrative export to gastroenterology centers, specialized IBD clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for the induction and long-term maintenance of remission in Ulcerative Colitis and Crohn’s Disease.

Product Overview

This highly advanced formulation utilizes a strictly calibrated, pH-dependent delivery system to transport a powerful anti-inflammatory payload completely intact through the acidic stomach, deploying it exactly at the site of the intestinal ulcerations.

The “Terminal Ileum Target & Mucosal Healing” Specialist:

• Mechanism 1 (The Localized Inflammatory Blockade): Unlike systemic immunosuppressants, Mesalazine (5-aminosalicylic acid or 5-ASA) acts topically on the inflamed mucosal lining of the gut. It violently inhibits the cyclooxygenase (COX) and lipoxygenase pathways in the intestinal walls. By completely shutting down the production of toxic prostaglandins and pro-inflammatory leukotrienes, it halts the bleeding, severe cramping, and chronic diarrhea associated with IBD.
• Mechanism 2 (The pH-Dependent Polymeric Matrix – CRITICAL): If a patient swallows raw 5-ASA, it is completely absorbed in the stomach, causing systemic toxicity while completely failing to reach the colon. Our Prolonged-Release (PR) formulation wraps the active core in a sophisticated Methacrylic Acid Copolymer shield. This polymer is utterly insoluble in stomach acid (pH 1.2). It only begins to dissolve when it reaches the alkaline environment of the terminal ileum and colon (pH > 7.0). Once triggered, the inner matrix slowly swells, continuously washing the diseased colon with the anti-inflammatory drug over several hours.
• The Chronic Maintenance Advantage: Because the drug acts locally and is poorly absorbed into the systemic bloodstream, patients can safely take massive daily doses (up to 4.8 grams) for years at a time, keeping them in clinical remission and preventing the need for devastating surgical bowel resections.

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Inert-Atmosphere Compounding & Polymer Shielding (CRITICAL COMPLIANCE): Manufacturing Mesalazine is a highly specialized process. The raw API aggressively degrades when exposed to atmospheric oxygen. Our specialized gastroenterology suites utilize nitrogen-flushed compounding environments and strictly controlled fluid-bed coating systems. This prevents premature oxidation on the factory floor and allows for the flawless application of the pH-dependent Methacrylic Acid Copolymers, ensuring the drug survives the stomach and deploys strictly in the diseased colon.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of inflammatory bowel disease:

• Ulcerative Colitis (Mild to Moderate): First-line therapy for the induction of remission in patients experiencing active flare-ups (bloody diarrhea, severe cramping).
• Ulcerative Colitis (Maintenance): Lifelong, daily therapy to prevent relapse and maintain clinical remission.
• Crohn’s Disease: Off-label utilization for maintaining remission in patients with ileocolonic or colonic Crohn’s disease.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist Guidelines):

• Induction of Remission (Active Flare): Typically 2.4 g to 4.8 g daily, given in divided doses.
• Maintenance of Remission: Typically 1.6 g to 2.4 g daily, often administered as a single daily dose to maximize compliance.
• Administration (THE INTACT RULE – FATAL CLINICAL FAILURE): The tablet MUST be swallowed completely whole with water. It must never be crushed, broken, or chewed. Destroying the prolonged-release polymer coating will cause the drug to be absorbed in the stomach, rendering it utterly useless for the colon and causing severe systemic toxicity.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Mesalamine-Induced Acute Intolerance Syndrome: In up to 3% of patients, Mesalazine can trigger a paradoxical reaction that exactly mimics an IBD flare-up (severe cramping, acute abdominal pain, bloody diarrhea, and fever). If suspected, the drug must be withdrawn immediately.
• Severe Renal Impairment (Nephrotoxicity): While mostly acting locally, a small percentage of the drug is absorbed and excreted by the kidneys. Rare cases of severe interstitial nephritis and renal failure have occurred. Renal function (BUN/Creatinine) must be monitored prior to and during long-term therapy.
• Hepatic Impairment & Blood Dyscrasias: Rare but severe risks of hepatotoxicity, aplastic anemia, and severe leukopenia. Patients should be monitored for unexplained bleeding, bruising, or severe sore throat.
• Salicylate Allergy (Absolute Contraindication): Mesalazine is a salicylate (chemically related to Aspirin). It is strictly contraindicated in patients with a known severe hypersensitivity or anaphylaxis to Aspirin.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gastroenterology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced IBD, Prolonged-Release, and Polymer-Coated Formulations. Whether you are looking for a reliable Government Tender Supplier for auto-immune clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.