Description

Sodium Aminosalicylate Granules 80% w/w

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Sodium Aminosalicylate Granules (80% w/w) in India. This is a critical Second-Line Anti-Tuberculosis Drug used in the treatment of Multi-Drug Resistant Tuberculosis (MDR-TB). Because the required daily dosage of Para-aminosalicylic acid (PAS) is very high (often 10-12 grams), it cannot be conveniently formulated into tablets. Instead, we manufacture it as highly concentrated enteric-coated granules.

We offer Contract Manufacturing (Third Party) services for this niche infectious disease product. Our formulation is designed to be Enteric-Coated, which protects the drug from degrading in stomach acid and prevents the severe gastric irritation common with older PAS formulations. Our WHO-GMP certified facility in Mumbai utilizes specialized Fluid Bed Processing technology to produce these granules. Healthy Inc manages the export logistics, supplying National Tuberculosis Elimination Programs (NTEP) and NGOs across India, Africa, and CIS countries.

2. Product Specifications

3. Manufacturing Technology

Handling high-dose, moisture-sensitive drugs requires specialized coating.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enteric Coating (Acid Resistance): Sodium Aminosalicylate degrades rapidly in acidic environments (stomach acid) into toxic meta-aminophenol. We use Fluid Bed Coating technology to coat the granules with an acid-resistant polymer. This ensures the drug passes through the stomach intact and releases only in the neutral pH of the small intestine.

  • Moisture Protection: The drug is highly hygroscopic and unstable in humidity. We manufacture in Ultra-Low Humidity Suites (< 25% RH) to prevent degradation during processing.

  • High-Load Granulation: Achieving an 80% drug load means the granules are mostly pure drug with very little excipient. This keeps the total volume of granules the patient must swallow to a minimum.

• The Exporter: Healthy Inc

  • Sachet Packaging: We package these granules in High-Barrier Aluminium Sachets. This is the only packaging format that guarantees the stability of the granules against moisture and light during storage in tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Acid Resistance: We test that < 10% of the drug is released in simulated gastric fluid (0.1N HCl) after 2 hours.

• Dissolution: We verify that the drug releases rapidly (> 80%) once it reaches the simulated intestinal fluid (pH 6.8 buffer).

• Impurity Profiling: We strictly monitor for m-Aminophenol, a toxic degradation product that must be kept below strict limits (usually < 0.2%).

5. Why Use Sodium Aminosalicylate Granules?

It is a vital component of the MDR-TB regimen.

• Mechanism: It is a bacteriostatic agent that inhibits the synthesis of folic acid in the tuberculosis bacteria (similar to sulfonamides but specific to Mycobacteria).

• Key Indications:

  • MDR-TB: Used in combination with other second-line drugs (like Levofloxacin, Cycloserine, Ethionamide) when the patient is resistant to Isoniazid and Rifampicin.

• Advantage: The enteric-coated granule form significantly reduces the nausea, vomiting, and abdominal pain that historically made PAS therapy difficult for patients to tolerate.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sodium Aminosalicylate Granules?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using fluid-bed coating technology.

• Q: How do you take the granules?

  A: The granules should be sprinkled onto an acidic soft food (like yogurt or applesauce) or swallowed whole with acidic juice (orange/tomato). Do not chew or crush the granules, as this destroys the protective coating and will cause stomach pain.

• Q: Why granules and not tablets?

  A: The daily dose is often 8 to 12 grams. Making this into 500mg tablets would require the patient to swallow 24 tablets a day. Granules are much easier to swallow in high volumes.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 150 mg/kg/day divided into 2 or 3 doses.

  • Typical Adult Dose: 4 grams (one sachet) taken 2 to 3 times daily.

• Administration: Swallow granules whole without chewing. Rinse mouth with water after swallowing to ensure no granules are stuck in the teeth (as the coating can dissolve and cause irritation).

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, diarrhea, and abdominal pain are common but reduced with enteric coating.

• Hypothyroidism: Long-term use can block iodine uptake by the thyroid. Monitor TSH levels.

• Liver: Hepatitis is a rare but serious risk. Monitor liver enzymes.

• Interactions: Vitamin B12 absorption may be reduced.

10. Storage Instructions

• Store strictly below 25°C. (Heat causes rapid degradation).

• Do not freeze.

• Keep sachets intact until time of use. If a sachet is swollen, do not use (indicates degradation).