In the pharmaceutical industry, the combination of Diclofenac Potassium and Paracetamol is a potent Fixed-Dose Combination (FDC) categorized as a dual-action analgesic and anti-inflammatory.
As a pharmacist and manufacturer, I view this as a “fast-acting” synergy. While Paracetamol is a standard pain reliever, the addition of the Potassium salt of Diclofenac (rather than the Sodium salt) ensures quicker absorption, making this combination ideal for acute conditions where rapid relief is the priority.
Primary Clinical Uses
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Acute Musculoskeletal Pain: Effective for backaches, sprains, strains, and sports injuries.
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Post-Operative & Dental Pain: Widely prescribed after minor surgeries or tooth extractions to manage both trauma-induced pain and swelling.
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Inflammatory Conditions: Symptomatic relief for Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis.
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Gynecological Pain: Highly effective for severe dysmenorrhea (period cramps) due to its ability to inhibit prostaglandins in the uterine tissue.
Mechanism of Action: The Synergistic Attack
1. Diclofenac Potassium (50 mg)
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Action: A non-selective COX-1 and COX-2 inhibitor.
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Result: It reduces the production of prostaglandins at the site of injury. Because it is the Potassium salt, it dissolves more rapidly in the stomach than Diclofenac Sodium, leading to a faster onset of action (typically within 15–30 minutes).
2. Paracetamol (325 mg – 500 mg)
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Action: Primarily acts on the Central Nervous System (CNS).
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Result: It raises the overall pain threshold and acts as an antipyretic to reduce fever. When paired with Diclofenac, it provides a “central” block to pain while the Diclofenac provides a “peripheral” block at the site of inflammation.
The Manufacturer’s Perspective: Technical & Export
From a production standpoint at your WHO-GMP facility in Mumbai, this formulation offers significant B2B advantages:
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The “Potassium” USP: On your digital platforms, you should highlight that your formulation uses Diclofenac Potassium. For B2B buyers, this is a “Premium” version of the drug compared to the slower-acting Sodium version, justifying a better market position.
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Gastric Protection: Diclofenac can be hard on the stomach. At our facility, we often utilize Film-Coating technology to protect the gastric mucosa and mask the bitter taste of the APIs, which improves patient compliance.
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Stability & Packaging: Both APIs are sensitive to moisture. We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to ensure a 36-month shelf life, which is critical for your export business to Zone IVb regions.
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Dossier Support: Our Mumbai-based firm provides full CTD/eCTD Dossiers to support international registration and supply against global brands like Voveran Plus.