Description

Sulfasalazine Tablets (Enteric Coated / Delayed Release)

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 Sulfasalazine Tablets in India. This is a powerful Disease-Modifying Anti-Rheumatic Drug (DMARD) and anti-inflammatory agent used extensively for the management of Ulcerative Colitis, Crohn’s Disease, and Rheumatoid Arthritis.

We offer Contract Manufacturing (Third Party) services for this specialized formulation. Sulfasalazine is composed of 5-aminosalicylic acid (5-ASA) linked to sulfapyridine. To minimize gastric distress (nausea/vomiting), which is common with this drug, we primarily manufacture it as Enteric Coated (Gastro-Resistant) tablets. Our WHO-GMP certified facility in Mumbai utilizes advanced coating technologies to ensure the drug bypasses the stomach and releases locally in the intestine where it is needed. Healthy Inc manages the export logistics, supplying gastroenterology and rheumatology clinics across Europe, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precise coating is essential for patient tolerability.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enteric Coating: Standard Sulfasalazine can cause severe nausea and indigestion. We apply a robust Methacrylic Acid Copolymer Coating that resists stomach acid (pH 1.2) and dissolves only in the higher pH of the intestines (pH 7.0+). This drastically improves patient compliance.

  • Color Handling: Sulfasalazine is an intense yellow-orange dye. We use dedicated manufacturing suites with specialized dust containment systems to prevent cross-contamination of other products in the facility.

  • Granulation: We use optimized wet granulation to ensure the tablet core is hard enough to withstand the coating process without chipping.

• The Exporter: Healthy Inc

  • Stability: We use high-grade HDPE bottles or Alu-Alu Blisters to protect the product from light, which can cause the tablets to darken and lose potency.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (Two-Stage):

  • Acid Stage: < 10% release in 2 hours (ensures stomach protection).

  • Buffer Stage: > 85% release in 60 minutes (ensures intestinal availability).

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurities: We strictly monitor for free Sulfapyridine and Salicylic Acid to ensure the stability of the azo bond.

5. Why Use Sulfasalazine?

It is a dual-action therapy for gut and joint inflammation.

• Mechanism: In the colon, bacteria break the drug into two parts:

  • 5-ASA (Mesalamine): Acts locally to reduce inflammation in the colon (treating Colitis).

  • Sulfapyridine: Absorbed into the body to reduce systemic inflammation (treating Arthritis).

• Key Indications:

  • Ulcerative Colitis: Induction and maintenance of remission.

  • Rheumatoid Arthritis: Used when NSAIDs alone are insufficient to slow joint damage.

  • Juvenile Idiopathic Arthritis: Treatment for children who do not respond to salicylates.

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 Sulfasalazine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is the tablet orange?

  A: The active ingredient is naturally distinctively orange. This color can also pass into bodily fluids.

• Q: Will this stain my contact lenses?

  A: Yes. Sulfasalazine can permanently stain soft contact lenses yellow. Patients are advised to wear glasses during treatment.

• Q: Is it safe if I am allergic to Aspirin?

  A: NO. Because it breaks down into a salicylate (related to Aspirin) and a sulfonamide (sulfa drug), it is contraindicated in patients with allergies to either.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Ulcerative Colitis: 3g to 4g daily in divided doses. Maintenance: 2g daily.

• Rheumatoid Arthritis: Started low (500mg) and titrated up to 2g or 3g daily.

• Administration: Swallow whole. Do not crush or chew enteric-coated tablets. Take after meals with a full glass of water.

9. Side Effects and Precautions

• Body Fluid Discoloration: Urine and skin may turn an orange/yellow color. This is harmless but can be alarming if unexpected.

• Male Fertility: Can cause a reversible decrease in sperm count (oligospermia). Fertility returns upon stopping the drug.

• Blood Disorders: Rare risk of bone marrow suppression (leukopenia). Monitor CBC.

• Contraindications: Porphyria, intestinal/urinary obstruction, Sulfa/Salicylate allergy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Tablets may darken if exposed).