In the pharmaceutical industry, the combination of Diclofenac Sodium and Paracetamol (Acetaminophen) is a powerful Fixed-Dose Combination (FDC) that pairs a potent NSAID with a centrally acting analgesic.

As a pharmacist and manufacturer, I view this as a “synergistic” formulation: Diclofenac targets peripheral inflammation at the site of injury, while Paracetamol elevates the overall pain threshold in the brain.

Primary Clinical Uses

• Acute Musculoskeletal Pain: Highly effective for backaches, sprains, strains, and sports injuries.

• Arthritis Management: Used for symptomatic relief in Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

• Post-Operative Pain: Frequently prescribed after minor surgeries or dental extractions to manage both pain and swelling.

• Gout: Used to manage the intense pain and inflammation during acute gouty attacks.

• Gynecological Pain: Effective for severe primary dysmenorrhea (period cramps).

Dual Mechanism of Action (The 2-Pronged Attack)

1. Diclofenac Sodium (The Anti-Inflammatory)

• Action: A potent inhibitor of the COX-1 and COX-2 enzymes.

• Result: It stops the synthesis of prostaglandins at the site of injury. By reducing these “chemical messengers,” it directly reduces swelling, redness, and localized pain.

2. Paracetamol (The Pain-Threshold Booster)

• Action: Primarily acts on the Central Nervous System (CNS).

• Result: It increases the body’s overall tolerance to pain and helps reduce fever.

• The Synergy: When combined, they provide better pain relief than a double dose of either drug alone, often allowing for a lower (and safer) dose of the NSAID.

The Manufacturer’s Perspective: Technical & Export

From a production standpoint at a WHO-GMP facility in Mumbai, this FDC is a high-volume “bread and butter” product:

• Enteric Coating (The Diclofenac Challenge): As a firm owner, you know Diclofenac is notoriously hard on the stomach. Many of our premium formulations use enteric-coated Diclofenac granules within the tablet to protect the gastric mucosa and prevent “acid reflux” complaints from patients.

• Common Strengths: The most popular export ratio is Diclofenac Sodium 50 mg + Paracetamol 325 mg or 500 mg.

• Stability for Export: We utilize Alu-Alu blister packaging to protect the integrity of the APIs from the high humidity found in Zone IVb regions (Africa and Southeast Asia), ensuring a 36-month shelf life.

• B2B USP: This is an essential item for orthopedic and dental specialty distributors. Our Mumbai facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Voveran Plus).