Description
Sodium Aminosalicylate Granules % w/w
Healthy Inc is a specialized global supplier and exporter of second-line anti-tuberculosis agents (MDR-TB). We provide high-purity Sodium Aminosalicylate Granules (Enteric Coated), sourced from WHO–GMP certified facilities. This “Folate Starver” is a top export to MDR-TB specialized centers, DOTS-Plus programs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical reserve agent for Multi-Drug Resistant Tuberculosis.
Product Overview
This formulation contains Sodium Aminosalicylate, the sodium salt of Para-aminosalicylic acid (PAS).
The “Acid-Resistant” Specialist:
- Mechanism (Folate Antagonist): PAS is structurally similar to Para-aminobenzoic acid (PABA) and sulfonamides. It acts as a competitive inhibitor of the bacterial enzyme dihydropteroate synthase, preventing *Mycobacterium tuberculosis* from synthesizing folic acid (essential for DNA replication). It is bacteriostatic.
- Gastro-Protection (Critical): Pure PAS is highly unstable in gastric acid. Exposure to stomach acid degrades it into meta-aminophenol, which is hepatotoxic and inactive. Our granules are Enteric Coated (Acid-Resistant) to pass safely through the stomach and release the drug only in the neutral pH of the small intestine.
- Resistance Breaker: It is used in combination regimens to prevent the emergence of resistance to other drugs (like Isoniazid and Rifampicin) in MDR-TB cases.
Product Composition & Strength
We supply this product as Enteric Coated Granules packed in single-dose sachets. The percentage w/w indicates the concentration of the active drug within the granule matrix.
| Active Ingredient | Concentration (% w/w) | Sachet Strength | |
|---|---|---|---|
| Sodium Aminosalicylate USP/BP | 60% w/w | Eq. to 4 g PAS per sachet | |
| Sodium Aminosalicylate USP/BP | 80% w/w | High Concentration (Reduced Bulk) | |
| Excipients | Q.S. | Dibutyl Sebacate / Methacrylic Acid Copolymer | Acid-Resistant Coating |
*Pack Sizes: Sachets of 4g, 5.5g, or 9.2g depending on % strength. Box of 25s or 30s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Enteric Coated Granules (Oral) |
| Packaging | Aluminum-Polyethylene Laminated Sachet |
| Storage | Store below 25°C. Protect from Heat and Moisture. (Refrigeration preferred in hot climates). |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Cold Chain Stability: PAS granules are notoriously sensitive to heat (decarboxylation). Our manufacturing process utilizes Cold-Bed Fluidized Coating to apply the enteric layer without thermally degrading the API.
- pH-Dependent Release: We rigorously test dissolution at pH 1.2 (Stomach – 0% release) and pH 6.8 (Intestine – >85% release) to ensure the patient receives the full therapeutic dose without gastric toxicity.
Therapeutic Indications (Human Use)
Indicated as part of a multidrug regimen for:
- Multi-Drug Resistant Tuberculosis (MDR-TB): Used when resistance to Isoniazid and Rifampicin is confirmed.
- XDR-TB (Extensively Drug-Resistant TB): Often included as a Group C or Group D add-on agent when other options fail.
Dosage & Administration
Recommended Dosage (Strictly as per WHO/MDR-TB Guidelines):
- Route: Oral.
- Adults: 150 mg/kg per day, divided into 2 to 3 doses.
- Standard: 4 g (one sachet) usually 2 to 3 times daily.
- Max Dose: 12 g per day.
- Administration (CRITICAL):
- Sprinkle granules on acidic soft food (yogurt, apple sauce) or suspend in acidic fruit juice (orange/tomato).
- DO NOT CHEW: Chewing destroys the enteric coating, leading to severe stomach pain and drug inactivation. Swallow whole.
- Avoid Neutral Drinks: Do not take with milk or antacids (premature dissolution).
Safety Warnings:
- Sodium Load (WARNING): Contains significant amounts of Sodium (approx 55 mg Na+ per 500 mg PAS). Use with extreme caution in patients with Congestive Heart Failure (CHF) or severe renal impairment.
- Hypothyroidism: PAS is goitrogenic (blocks iodine uptake). Long-term use can cause goiter and hypothyroidism. Monitor TSH levels.
- GI Disturbances: Diarrhea, nausea, and vomiting are very common.
- Storage: If sachets swell (due to CO2 release from degradation), DO NOT USE.
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.
