Description
Aminosalicylic Acid (PAS) Delayed-Release Tablets (500 mg / 1000 mg)
Healthy Inc is a specialized global supplier and exporter of advanced anti-infectives, pulmonology, and targeted high-containment therapeutics. We provide ultra-high-purity, kinetically optimized Aminosalicylic Acid Tablets, manufactured in WHO–GMP certified, high-precision specialized antibiotic facilities. This “Second-Line Anti-Tubercular Agent” is a critical strategic export to tuberculosis treatment centers, infectious disease hospitals, and government health ministries, serving as the globally mandated intervention for Multi-Drug Resistant Tuberculosis (MDR-TB).
Product Overview
This formulation operates as a “Folate Mimic.” It is chemically similar to para-aminobenzoic acid (PABA) and tricks the bacteria into incorporating it into their growth cycle, effectively starving the TB bacilli.
Mechanism 1 (Inhibition of Folic Acid Synthesis): Aminosalicylic Acid (PAS) competes with PABA for the enzyme dihydropteroate synthase. By physically blocking this enzyme, it prevents Mycobacterium tuberculosis from synthesizing Folic Acid, which is essential for bacterial DNA production and replication.
Mechanism 2 (Bacteriostatic Synergy): PAS is primarily bacteriostatic, meaning it stops bacteria from multiplying. When used in combination with other second-line drugs, it prevents the development of further resistance, acting as a “protector” for more potent agents.
Mechanism 3 (The Delayed-Release Advantage): Historically, PAS caused severe gastric irritation. Our tablets utilize an Advanced Enteric Coating that ensures the drug remains intact in the stomach (pH 1.2) and dissolves only in the small intestine (pH 5.5+), significantly improving patient tolerance and treatment adherence.
Product Composition & Strength
We supply this product as a Precision-Blended, Delayed-Release (DR) Tablet, packed in moisture-resistant Alu-Alu blister strips.
| Active Ingredient | Strength | Primary Clinical Function |
| 4-Aminosalicylic Acid USP/BP | 500 mg | The Standard Titration Unit: Allows for gradual dose escalation to manage gastrointestinal side effects. |
| 4-Aminosalicylic Acid USP/BP | 1000 mg | The Maintenance Payload: High-dose format for adult MDR-TB regimens requiring up to 8–12g daily. |
| Excipients | Acid-Resistant Polymer | Enteric Shield System: Engineered to bypass the stomach and release the API in the upper intestine for maximum absorption. |
Technical & Logistics Specifications
HS Code: 2922.50.11 (Aminosalicylic acids and their salts)
CAS Number: 65-49-6 (4-Aminosalicylic Acid)
Dosage Form: Delayed-Release / Enteric-Coated Tablet
Packaging: Alu-Alu Blisters (MANDATORY). PAS is sensitive to light and moisture; our high-barrier packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
Sodium-Free Synthesis: Many older versions used Sodium Aminosalicylate, which was dangerous for patients with heart or kidney issues. Healthy Inc provides the Acid form (PAS), which is sodium-free and safer for long-term MDR-TB therapy.
Bioequivalence Integrity: We provide comprehensive dissolution data (Acid vs. Buffer stages) to prove our tablets meet the highest international standards for delayed-release anti-tuberculars.
Primary Indications
Pulmonology: Treatment of Multi-Drug Resistant Tuberculosis (MDR-TB) in combination with other anti-mycobacterial agents.
Infectious Disease: Management of Extensively Drug-Resistant TB (XDR-TB) where other options are limited.
Gastroenterology: Off-label use in specific cases of inflammatory bowel disease (specialist supervision only).
Dosage & Administration
Standard Adult Dosing: Usually 8 g to 12 g per day, divided into two or three doses.
Pediatric Dosing: 200 mg/kg to 300 mg/kg per day in divided doses.
Administration: Tablets must be swallowed whole with water. Do not crush or chew, as this destroys the enteric coating.
Safety Warning: Hepatotoxicity. Monitor liver function tests (LFTs) regularly. May cause Hypothyroidism, especially when used with Ethionamide. Monitor for signs of severe hypersensitivity (rash/fever). Use with caution in patients with renal impairment.
Global Export & Contract Manufacturing
Healthy Inc is a premier Anti-TB Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for specialized second-line anti-infectives. Whether you are a National TB Program Director in Africa or a B2B Pharma Marketplace partner in Central Asia, we ensure secure, WHO-GMP compliant delivery.
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