In the pharmaceutical industry, Diclofenac Potassium BP is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) characterized by its rapid absorption and immediate-onset of action. As a pharmacist and manufacturer, I view the “Potassium” salt as the preferred version for acute, short-term pain management, as it dissolves faster in the stomach compared to the “Sodium” (delayed-release) version.

At your WHO-GMP facility in Mumbai, this 50 mg SKU is a core analgesic product, essential for surgical, dental, and orthopedic portfolios.

Primary Clinical Indications

• Acute Pain Management: Effective for fast relief of dental pain, post-operative pain, and soft tissue injuries.

• Migraine Relief: Used to treat acute migraine attacks, with or without aura, due to its rapid entry into the bloodstream.

• Dysmenorrhea: Primary treatment for painful menstrual cramps and associated discomfort.

• Inflammatory Conditions: Short-term relief for flare-ups of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Mechanism: COX Enzyme Inhibition

Diclofenac Potassium works by shutting down the “production line” of pain and inflammation in the body.

Enzyme Targeting: It is a non-selective inhibitor of the enzymes Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).

Prostaglandin Blockade: These enzymes are responsible for creating prostaglandins, the chemicals that signal pain, trigger fever, and cause swelling at the site of injury.

Potassium Advantage: Because the potassium salt is highly soluble, it reaches peak plasma concentration (Tmax) in approximately 30 to 60 minutes, providing faster relief than the sodium salt.

The Pharmacist’s “Technical Warning”

• The “GI” Shield: To minimize the risk of stomach ulcers or bleeding, it must be taken with or after a meal.

• Cardiovascular Risk: Chronic use, especially at high doses, is associated with an increased risk of serious cardiovascular thrombotic events (heart attack or stroke).

• The “NSAID Triad”: It should be avoided in patients with a history of asthma or nasal polyps who are sensitive to Aspirin, as it can trigger severe bronchospasm.

• Renal Monitoring: Long-term use requires monitoring of kidney function, especially in elderly patients or those on diuretics.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Rapid-Relief” USP: On your marketplace, market the Potassium BP version specifically for “Acute Care” and “Migraine Relief.” This distinguishes it from the Sodium salt used for chronic arthritis.

• Stability for Export: Diclofenac is stable but sensitive to moisture. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life in Zone IVb tropical regions.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for bidding on surgical-supply contracts.