In the pharmaceutical industry, Diclofenac Sodium 25 mg is a potent non-steroidal anti-inflammatory drug (NSAID) of the phenylacetic acid derivative class. As a pharmacist, I view the 25 mg strength as a versatile “titration dose,” often used for acute pain management or as a starting dose to minimize gastrointestinal (GI) side effects.
Primary Clinical Uses
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Acute Pain Management: Effective for the short-term relief of mild to moderate pain, such as toothaches, primary dysmenorrhea (period pain), and post-operative pain.
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Inflammatory Conditions: Used to treat symptoms of Rheumatoid Arthritis (RA), Osteoarthritis (OA), and Ankylosing Spondylitis.
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Musculoskeletal Disorders: Relieves pain and inflammation associated with sprains, strains, backache, and tendonitis.
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Migraine Attacks: In specific fast-acting formulations (like potassium salts or specific sodium dispersibles), it is used to treat acute migraine episodes.
Mechanism of Action
Diclofenac Sodium works by inhibiting the enzyme Cyclooxygenase (COX). Specifically, it inhibits both COX-1 and COX-2, though it shows a slight preference for COX-2.
By blocking these enzymes, Diclofenac prevents the synthesis of prostaglandins—the chemical messengers responsible for signaling pain, inducing fever, and causing inflammation. Unlike the potassium salt version (which is faster-acting), the sodium salt is typically formulated for a slightly more sustained release to provide longer-lasting relief.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Diclofenac Sodium is a high-volume “essential” product:
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Enteric Coating (Critical): Diclofenac is notorious for causing gastric irritation. As a WHO-GMP manufacturer, we almost always apply a high-quality enteric coating to these tablets. This ensures the drug bypasses the acidic environment of the stomach and dissolves in the small intestine, significantly improving patient tolerance.
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Stability & Shelf Life: Diclofenac is stable, but sensitive to moisture. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life, which is a key selling point for export to Zone IVb regions like Africa, Southeast Asia, and the Middle East.
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Regulatory Documentation: We provide full CTD/eCTD Dossiers and comparative dissolution studies against the innovator (Voltaren) to support our B2B partners in rapid international registration.
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Market Positioning: The 25 mg dose is frequently used in pediatric or geriatric populations where lower dosing is required to manage the safety profile.