Healthy Inc > Blog > anti-inflammatory drug export
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What is diclofenac sodium 25 mg used for?

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

  • 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.

  • Inflammatory Conditions: Used to treat symptoms of Rheumatoid Arthritis (RA), Osteoarthritis (OA), and Ankylosing Spondylitis.

  • Musculoskeletal Disorders: Relieves pain and inflammation associated with sprains, strains, backache, and tendonitis.

  • 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:

  • 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.

  • 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.

  • 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.

  • Market Positioning: The 25 mg dose is frequently used in pediatric or geriatric populations where lower dosing is required to manage the safety profile.

Paracetamol Diclofenac sodium tablets

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What are Diclofenac Potassium 50 mg tablets used for?

In the pharmaceutical industry, Diclofenac Potassium 50 mg is a potent, fast-acting non-steroidal anti-inflammatory drug (NSAID). As a pharmacist, I distinguish this from the Sodium salt primarily by its pharmacokinetics: the Potassium salt is more water-soluble, allowing for rapid absorption and a faster onset of analgesic action, making it the preferred choice for acute pain.

Primary Clinical Uses

  • Acute Pain Relief: Specifically indicated for the rapid treatment of acute painful conditions such as migraine attacks, toothaches, and post-operative pain.

  • Primary Dysmenorrhea: Widely used to manage severe menstrual cramps due to its ability to quickly inhibit prostaglandin synthesis in the uterus.

  • Musculoskeletal Injuries: Effective for acute sprains, strains, and sports injuries where rapid reduction of inflammation and pain is required.

  • Inflammatory Conditions: Management of flare-ups in Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis.

Mechanism of Action

Diclofenac Potassium works by inhibiting the enzymes Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2). This inhibition halts the conversion of arachidonic acid into prostaglandins, which are the primary mediators of pain, fever, and inflammation.

Because the potassium salt dissolves more quickly in the stomach’s neutral-to-acidic environment than the sodium version, it reaches peak plasma concentration ($T_{max}$) in approximately 20–60 minutes, compared to 2 hours for the sodium salt.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Diclofenac Potassium 50 mg is a high-demand “fast-relief” product:

  • Non-Enteric Coating: Unlike the sodium version (which is often enteric-coated for slow release), the potassium version is usually film-coated. This ensures the tablet disintegrates immediately in the stomach for rapid absorption.

  • Hygroscopic Protection: Diclofenac Potassium is more sensitive to moisture than the sodium salt. As a WHO-GMP manufacturer, we utilize Alu-Alu blister packaging to ensure the stability of the API and maintain a 36-month shelf life in Zone IVb climates.

  • API Purity: We adhere to strict BP/USP/IP standards, monitoring for impurities like “Indolinone” to ensure the highest safety profile for export.

  • B2B & Tender Supply: This is a staple for pharmacy chains and emergency medical supplies. Our Mumbai-based hub provides full CTD/eCTD Dossiers to support international partners in rapid registration.

 

 

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