In the pharmaceutical industry, the combination of Diclofenac Sodium (50 mg) and Paracetamol (typically 325 mg or 500 mg) is a powerful Fixed-Dose Combination (FDC).

As a pharmacist and manufacturer, I classify this as a “Synergistic Analgesic.” While Paracetamol works primarily on the central nervous system, Diclofenac targets peripheral inflammation. Together, they provide much stronger pain relief than either drug could achieve alone, often allowing for lower doses of each API.

Primary Clinical Uses

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

• Arthritic Conditions: Management of acute flares in Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

• Post-Operative Pain: Used in minor surgical and dental procedures to control both pain and swelling.

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

• Inflammatory Conditions: Treatment of painful inflammatory conditions of the ENT (Ear, Nose, Throat) like tonsillitis or sinusitis.

Mechanism of Action: The Dual-Pathways

This combination attacks pain and inflammation from two distinct angles:

1. Diclofenac Sodium (The NSAID)

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

• Result: It stops the synthesis of prostaglandins at the site of injury. This directly reduces peripheral inflammation, redness, and swelling.

2. Paracetamol (The Antipyretic Analgesic)

• Action: Primarily inhibits prostaglandin synthesis in the Central Nervous System (CNS).

• Result: It raises the overall pain threshold and reduces fever, acting as a “buffer” for the nervous system.

Technical Synergy: Because Diclofenac can sometimes be hard on the stomach, combining it with Paracetamol often allows for a 50 mg dose of Diclofenac to feel as effective as a 75 mg or 100 mg dose, reducing the risk of gastric irritation.

The Manufacturer’s Perspective: Technical & Export

Producing this FDC at a WHO-GMP facility like yours in Mumbai requires specific technical attention:

• Enteric Coating Choice: Diclofenac Sodium is an acid-stable molecule but can cause gastric mucosal damage. Many manufacturers choose to use Enteric-Coated (EC) Diclofenac granules within the tablet to ensure it passes the stomach and dissolves in the intestine, protecting the patient’s gastric lining.

• Stability for Export: This combination is relatively stable. However, to maintain a 36-month shelf life in Zone IVb (hot and humid climates), we utilize Alu-Alu or high-barrier Blister packaging.

• B2B USP: This is a high-volume, high-demand product in the African and Southeast Asian markets. On your digital platforms, you can market this as a “Value-Added Analgesic” for surgical and orthopedic pharmacies.

• Dossier Support: Our Mumbai facility provides full CTD/eCTD Dossiers to support your international registration against standard generic competitors.