In the pharmaceutical industry, Aceclofenac is classified as a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) of the phenylacetic acid group. As a pharmacist and manufacturer, I view it as an evolution of Diclofenac—specifically modified to be “strong” enough for chronic inflammatory pain while being significantly gentler on the gastric mucosa.
At your WHO-GMP facility in Mumbai, Aceclofenac is likely a top-tier SKU in your orthopedic and rheumatology portfolios. Its ability to achieve high concentrations in synovial fluid makes it a “strong” choice for joint-specific pain.
Analgesic Strength & Comparison
Aceclofenac is considered a highly effective analgesic, particularly for musculoskeletal and inflammatory pain.
| Comparator | Relative Strength & Profile |
| vs. Paracetamol | Significantly stronger; Aceclofenac provides superior relief for inflammatory conditions like arthritis. |
| vs. Diclofenac | Comparable in potency ($100\text{ mg}$ Aceclofenac $\approx$ $75\text{ mg}$ Diclofenac), but often preferred for better patient compliance and lower GI withdrawal rates. |
| vs. Naproxen | Similar efficacy in chronic conditions (OA/RA), but Aceclofenac typically has a faster onset of action. |
Mechanism: Preferential COX-2 Inhibition
Aceclofenac is a “preferential” COX-2 inhibitor, which is the secret to its balanced strength and safety profile.
Enzyme Targeting: It primarily blocks the COX-2 enzyme, which is responsible for producing the prostaglandins that cause pain and swelling at the site of injury.
Gastric Sparing: Because it has less effect on the COX-1 enzyme (which protects the stomach lining), it is “strong” on pain but “weak” on causing stomach ulcers compared to traditional NSAIDs.
Chondroprotection: Unique to Aceclofenac, it may stimulate the synthesis of glycosaminoglycans in the cartilage, potentially slowing joint degradation in osteoarthritis—a major advantage over many other “strong” painkillers.
The Pharmacist’s “Technical Warning”
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The “Cardio” Caution: Like all COX-2 preferential drugs, long-term high doses may increase the risk of cardiovascular events (heart attack/stroke). Use with caution in patients with pre-existing heart conditions.
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Renal Monitoring: Chronic use can impair kidney function, particularly in the elderly or those on diuretics. Regular monitoring of renal parameters is mandatory for long-term therapy.
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Asthma Trigger: It can trigger “Aspirin-sensitive asthma.” Always screen patients for a history of NSAID-induced bronchospasm.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “FDC” USP: On your marketplace, highlight your Aceclofenac + Paracetamol or Aceclofenac + Serratiopeptidase combinations. These are the “Gold Standard” for post-operative and trauma pain in the Indian and SE Asian markets.
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Stability for Export: Aceclofenac 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.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international orthopedic and pain management tenders.