In the pharmaceutical industry, Diclofenac Sodium BP (British Pharmacopoeia) is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) with powerful analgesic, anti-inflammatory, and antipyretic properties. As a pharmacist and manufacturer, I view this molecule as a “Gold Standard” for managing conditions characterized by acute or chronic inflammation and pain.
At your WHO-GMP facility in Mumbai, Diclofenac Sodium is a versatile core product, typically manufactured as 50 mg enteric-coated tablets, 75 mg/3 mL injections, or topical gels for global B2B distribution.
Primary Clinical Indications
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Arthritic Conditions: Long-term management of Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis.
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Acute Musculoskeletal Disorders: Effective for strains, sprains, tenosynovitis, and back pain.
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Post-Operative Pain: Management of inflammation and pain following surgical procedures.
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Acute Gout: Rapid relief from the intense pain and swelling of gout attacks.
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Dysmenorrhea: Relief from severe menstrual cramping.
Mechanism: The COX Enzyme Inhibitor
Diclofenac Sodium works by shutting down the “production line” of inflammatory chemicals in the body.
COX Inhibition: It inhibits the enzymes Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).
Prostaglandin Synthesis: By blocking these enzymes, it prevents the conversion of arachidonic acid into prostaglandins, which are the primary mediators of pain, fever, and swelling.
Potency: Diclofenac is technically more potent than many other NSAIDs (like Ibuprofen), requiring a lower dose to achieve the same anti-inflammatory effect.
The Pharmacist’s “Technical Warning”
As you promote your firm on digital platforms, providing these technical nuances is essential for clinical authority:
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The “Enteric-Coating” Necessity: Diclofenac Sodium is notoriously hard on the stomach. Tablets are almost always Enteric-Coated (Gastro-resistant) to ensure they pass through the acidic stomach and dissolve in the intestine, reducing the risk of gastric ulcers.
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Cardiac/Renal Alert: Long-term use or high doses are associated with an increased risk of thrombotic events (heart attack/stroke) and can decrease renal blood flow. Use with caution in patients with pre-existing heart or kidney conditions.
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The “No-Crush” Rule: Advise patients that enteric-coated tablets must be swallowed whole. Crushing them destroys the protective coating and can lead to immediate gastric irritation.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Sodium vs. Potassium” USP: On your marketplace, clarify the difference for buyers. Diclofenac Sodium is typically slower-release and better for chronic inflammation, while Diclofenac Potassium is faster-acting and preferred for acute pain.
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Stability for Export: Diclofenac Sodium is stable but requires protection from moisture. Utilizing Alu-Alu blister packaging is the professional standard for maintaining a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for private B2B pharmacy networks.