Description

Paracetamol and Caffeine Anhydrous 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 and Caffeine Anhydrous Tablets in India. This is a high-efficacy analgesic formulation where Caffeine Anhydrous acts as a powerful adjuvant to Paracetamol. By stripping the water molecule from caffeine (making it “anhydrous”), we ensure a more concentrated and stable form that significantly potentiates the pain-relieving effects of Paracetamol by up to 40%, making it the preferred choice for severe headaches and migraines.

We offer Contract Manufacturing (Third Party) services for this product. Our WHO-GMP certified facility in Mumbai handles the hygroscopic nature of Caffeine Anhydrous with precision environmental controls to ensure tablet stability. Healthy Inc manages the export logistics, supplying major retail chains, pharmacies, and distributors across Africa, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Handling “Anhydrous” ingredients requires specific expertise.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Control: Caffeine Anhydrous is hygroscopic (it readily absorbs moisture from the air). We manufacture these tablets in Low-Humidity Suites (< 40% RH) to prevent the caffeine from clumping or degrading the tablet hardness.

  • Homogeneity: Since the dose of Caffeine (30-65mg) is small relative to Paracetamol (500mg), we use Geometric Mixing and high-shear granulation to ensure that caffeine is evenly distributed. This prevents “dose dumping” or inconsistent efficacy between tablets.

  • Coating: We use a moisture-barrier Film Coating (Opadry) to seal the tablet, masking the intense bitterness of the caffeine and protecting the anhydrous state of the drug.

• The Exporter: Healthy Inc

  • Packaging: We prioritize PVDC-coated PVC Blisters or Alu-Alu packs. This high-barrier packaging is essential to stop moisture ingress during sea transport, which could otherwise cause the Caffeine Anhydrous to absorb water and destabilize the tablet.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We test specifically for Caffeine Anhydrous content to ensuring it meets the 90-110% potency limit.

• Dissolution: We verify that the Paracetamol releases rapidly (typically >85% in 15 minutes) to validate the “Fast Relief” claim often associated with this combination.

• Related Substances: We monitor for 4-aminophenol (Paracetamol impurity) and specific Caffeine degradation products.

5. Why Use Paracetamol + Caffeine Anhydrous?

It provides “Extra Strength” relief without increasing the dose of Paracetamol.

• Mechanism:

  • Paracetamol: Increases the pain threshold in the brain.

  • Caffeine Anhydrous: Constricts dilated blood vessels in the brain (vasoconstriction), which is directly effective against vascular headaches (migraines). It also speeds up the absorption of Paracetamol in the stomach.

• Key Indications:

  • Migraine: The gold standard OTC treatment for migraine attacks.

  • Tension Headache: Relieves the “tight band” feeling around the head.

  • Dental Pain: Effective for acute 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 Caffeine Anhydrous Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using specialized humidity-controlled processes.

• Q: What does “Anhydrous” mean?

  A: It means “without water.” Anhydrous Caffeine is more potent by weight than hydrous caffeine and is the pharmaceutical standard for tablet formulations.

• Q: Is this the same as Panadol Extra?

  A: Yes, the 500mg/65mg formulation is chemically equivalent to Panadol Extra.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 2 tablets every 4 to 6 hours as needed.

• Maximum Dose: Do not exceed 8 tablets in 24 hours.

• Administration: Can be taken on an empty stomach, though food reduces the risk of caffeine-induced jitters.

9. Side Effects and Precautions

• Caffeine Sensitivity: May cause insomnia, nervousness, irritability, or tachycardia (fast heart rate).

• Gastric Acidity: Caffeine increases stomach acid secretion; use with caution in patients with GERD or ulcers.

• Hepatotoxicity: Contains Paracetamol. Overdose can cause severe liver damage.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture to maintain the anhydrous state.