Description

Paracetamol & Diclofenac Potassium Tablets

(500mg / 50mg)

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 Diclofenac Potassium Tablets in India. While standard painkillers use Diclofenac Sodium (which is often delayed-release), this formulation uses Diclofenac Potassium. The Potassium salt is significantly more water-soluble, allowing it to dissolve immediately in the stomach and enter the bloodstream in as little as 10-15 minutes.

This “Rapid Action” formulation is the preferred choice for Acute Pain where speed is critical, such as Dental Pain, Migraine, Dysmenorrhea (period pain), and post-traumatic injury. We offer Contract Manufacturing (Third Party) services for this premium analgesic. Our WHO-GMP certified facility in Mumbai utilizes Flash-Disintegration Technology to complement the fast-acting salt, ensuring the tablet breaks down instantly upon ingestion. Healthy Inc manages the export logistics, supplying dental supply chains and pharmacy networks across Latin America, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Engineered for speed.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Solubility Enhancement: The Potassium salt is naturally soluble, but we enhance this by using Super-Disintegrants (Crospovidone) that cause the tablet to burst apart within 60 seconds of hitting stomach acid. This ensures the drug is available for absorption almost immediately.

  • Gastric Tolerance: Rapid release can sometimes irritate the stomach. We use micro-buffering agents in the granulation to neutralize the local pH environment during disintegration, minimizing the “burn” often associated with uncoated NSAIDs.

  • Taste Masking: Diclofenac Potassium is bitter. We apply a specialized Sweetened Film Coat (Vanillin/Sucralose) that makes the tablet palatable without delaying its action.

• The Exporter: Healthy Inc

  • Specialized Indications: We market this specifically as a “Dental Pain” or “Period Pain” specialist product, distinct from general body-ache formulations.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >85% of the drug releases within 15 minutes (compared to 45 mins for Sodium salt).

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

• Salt Identification: We perform specific Flame Photometry tests to verify the presence of Potassium, ensuring no substitution with cheaper Sodium salt.

5. Why Use Diclofenac Potassium?

The 15-minute miracle.

• Mechanism:

  1. The Potassium Advantage: Diclofenac Sodium is slow to dissolve and is often enteric-coated to bypass the stomach. Diclofenac Potassium dissolves in the stomach. This allows it to reach peak blood levels (T-max) in 20-30 minutes, compared to 2-3 hours for the Sodium salt.

  2. Paracetamol Synergy: Paracetamol provides a baseline of pain relief, while the Diclofenac attacks the inflammation at the nerve root.

• Key Indications:

  • Dental Pain: Severe toothache, root canal pain, post-extraction.

  • Dysmenorrhea: Rapid relief from menstrual cramps.

  • Migraine: Aborts the headache in the early prodrome phase.

  • Acute Injury: Sprains, strains, and fractures.

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 these tablets?

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

• Q: What is the difference between Diclofenac Sodium and Potassium?

  A: Speed. Potassium acts quickly (within 15-30 mins) and is for sharp, acute pain. Sodium acts slowly (1-2 hours) and is better for chronic pain like arthritis.

• Q: Is it safe for the stomach?

  A: Use caution. Because it releases in the stomach (to work fast), it can cause irritation. Always take it after food.

• Q: Is it Cataflam?

  A: Cataflam is the brand name (Novartis). We manufacture the Generic Equivalent (Diclofenac Potassium + Paracetamol).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1 tablet every 8 hours.

• Acute Pain (First Dose): Can take 2 tablets initially, followed by 1 tablet every 8 hours.

• Maximum Dose: Do not exceed 150mg Diclofenac / 3000mg Paracetamol per day.

• Administration: Swallow whole with water after a meal.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, indigestion, gastric pain. Higher risk of gastritis than enteric-coated sodium tablets.

• Cardiovascular: NSAIDs may increase risk of thrombotic events with long-term use.

• Liver: Contains Paracetamol; avoid alcohol.

• Contraindications: Active Peptic Ulcer, History of GI Bleeding, Severe Heart Failure, Aspirin-induced Asthma.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.