Description

Paracetamol, Diclofenac Sodium and Caffeine Tablets

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 Paracetamol, Diclofenac Sodium, and Caffeine Tablets in India. This Triple-Action Analgesic is a powerful formulation designed to treat moderate to severe pain accompanied by inflammation. It combines the antipyretic properties of Paracetamol, the potent anti-inflammatory action of Diclofenac Sodium, and the analgesic-enhancing effect of Caffeine.

We offer Contract Manufacturing (Third Party) services for this high-efficacy formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced multi-stage granulation techniques to ensure the chemical stability of all three ingredients in a single dosage form. Healthy Inc manages the export logistics, supplying pharmacies, hospitals, and distributors across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Combining three active ingredients requires precise formulation science.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Synergistic Blending: Caffeine enhances the absorption of Paracetamol, but it must be evenly distributed. We use High-Shear Granulation to ensure uniform content uniformity, preventing “hot spots” of caffeine.

  • Stability Protection: Diclofenac can degrade in the presence of moisture, while Caffeine is hygroscopic. We use specific binders and low-moisture processing environments to ensure the tablet remains stable and effective.

  • Taste Masking: Both Diclofenac and Caffeine have bitter taste profiles. We apply a high-quality Film Coating (Opadry) to mask the bitterness and ensure patient compliance.

• The Exporter: Healthy Inc

  • Moisture Barrier: To protect the triple formulation from humidity during global transit, we utilize PVDC coated PVC Blisters or Alu-Alu packs. This ensures the product reaches the destination with full potency.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test the release rates of all three components. Paracetamol and Caffeine must release rapidly for quick relief, while Diclofenac releases to target inflammation.

• Assay: We use HPLC methods to simultaneously quantify Paracetamol, Diclofenac, and Caffeine, ensuring 100% label claim.

• Related Substances: We strictly monitor for degradation impurities (such as 4-aminophenol and Indolinone) to guarantee safety.

5. Why Use This Triple Combination?

It offers superior pain relief compared to monotherapy.

• Mechanism:

  • Paracetamol: Reduces fever and blocks pain signals in the brain.

  • Diclofenac Sodium: An NSAID that reduces inflammation, swelling, and pain at the injury site.

     

  • Caffeine: Constricts blood vessels (helping with headaches) and increases the absorption and efficacy of the analgesics by up to 40%.

• Key Indications:

  • Severe Headache & Migraine: The caffeine component specifically targets vascular headaches.

  • Musculoskeletal Pain: Back pain, body aches, and muscle strains.

  • Post-Viral Fatigue/Pain: Relieves the “tired and aching” feeling associated with flu or fever.

  • Dental Pain: Effective for inflammatory toothache.

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 Paracetamol Diclofenac Caffeine Tablets?

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

• Q: Why is Caffeine added?

  A: Caffeine acts as an adjuvant; it makes the painkillers work faster and stronger, and it helps combat the drowsiness sometimes associated with pain.

• Q: Is this safe for long-term use?

  A: No, it is intended for short-term management of acute pain. Long-term use of NSAIDs like Diclofenac requires medical supervision.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet 2 to 3 times daily after meals.

• Maximum Dose: Do not exceed 3 tablets in 24 hours.

• Administration: Must be taken after food to reduce gastric irritation from Diclofenac and Caffeine.

9. Side Effects and Precautions

• Common Side Effects: Nausea, heartburn, insomnia (due to caffeine), and jitteriness.

• Gastric Safety: Avoid in patients with active peptic ulcers or hyperacidity.

• Cardiac Precautions: Caffeine can cause tachycardia (fast heart rate); use with caution in patients with heart conditions or high blood pressure.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.