In the pharmaceutical industry, Indomethacin 25 mg is recognized as one of the most potent Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) of the indole acetic acid class. As a pharmacist, I view Indomethacin as a “heavy-duty” analgesic—while it is highly effective, its potency requires careful monitoring of the gastric and renal systems compared to milder NSAIDs like Ibuprofen.

Primary Clinical Uses

• Acute Gouty Arthritis: Considered a first-line treatment for managing the intense pain, redness, and swelling of an acute gout attack.

• Ankylosing Spondylitis: A primary therapy for reducing spinal pain and stiffness in this chronic inflammatory condition.

• Rheumatoid and Osteoarthritis: Used for moderate to severe cases that do not respond to other NSAIDs.

• Bursitis and Tendonitis: Effective for acute painful shoulder (calcific tendonitis) or inflammation of the bursa.

• Patent Ductus Arteriosus (PDA): In a specialized neonatal hospital setting, the injectable form is used to help close a persistent opening in a newborn’s heart.

  Mechanism of Action

Indomethacin is a non-selective inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes.

Prostaglandin Inhibition: It blocks the synthesis of prostaglandins—lipids that act as chemical messengers for pain and inflammation.

Anti-inflammatory Potency: It is significantly more potent than aspirin or ibuprofen in its ability to inhibit prostaglandin synthesis, which is why the 25 mg dose is so effective for severe inflammation.

Antipyretic Effect: Like other NSAIDs, it acts on the hypothalamus to reduce fever.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Indomethacin 25 mg involves specific technical considerations:

• Gastric Irritation Management: Indomethacin is highly associated with GI upset. As a WHO-GMP manufacturer, we often formulate these as enteric-coated capsules or tablets to protect the stomach lining and ensure the API is released in the small intestine.

• Solubility & Bioavailability: Indomethacin is a BCS Class II drug (low solubility, high permeability). We utilize micronization of the API and specific surfactants to ensure the 25 mg dose meets BP/USP/IP dissolution standards.

• Stability for Export: We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to protect the product from moisture and light, ensuring a 36-month shelf life for export to Zone IVb regions.

• B2B & Institutional Supply: Indomethacin is a staple for rheumatology clinics. Our Mumbai facility provides the CTD/eCTD Dossiers and stability data required for international registration against the innovator (Indocin).