Diclofenac Diethylamine Topical Gel/Emulsion 1%, 2% Suppliers & Bulk Manufacturers

Available Forms: Topical Gel/Emulsion

Available Strengths: 1%, 2%

Reference Brands: Voltaren Emulgel

Category: Analgesic

Diclofenac diethylamine 1% and 2% topical gel and emulsion-gel, a topical NSAID for musculoskeletal pain, for pharmacy distributors, importers, hospital pharmacies and OTC retail buyers.

Product Description:

Diclofenac diethylamine is a salt of diclofenac, an NSAID that blocks the COX enzymes and so reduces local prostaglandin production. Applied as a gel or emulsion-gel, it passes through the skin into the tissue beneath, with blood levels far below those from tablets. The 1% and 2% strengths are expressed as diclofenac sodium equivalent, matching 1.16% and 2.32% of the diethylamine salt. An emulsion-gel blends an oily phase into a water and alcohol gel.

It is used for local pain and inflammation from sprains, strains, bruises and soft-tissue injuries, and for osteoarthritis pain in knees and hands. The 1% gel is usually applied three or four times daily and the 2% twice daily, rubbed in gently; hands are washed afterwards unless they are the treated site. It is kept off broken skin, eyes and tight dressings. It is avoided in aspirin- or NSAID-sensitive asthma and in late pregnancy. Side effects are mostly local skin reactions.

Sourcing notes. Its sale category, general sale, pharmacy or prescription, varies by strength and market, so check it locally. Expect a CTD or ACTD dossier; regulators may ask for in vitro release or skin permeation data to support equivalence. Many formulations contain alcohol, so tubes need a sound seal and storage below the labelled temperature, with zone IVb stability for tropical markets. Ask for a CoA per batch with assay, pH, viscosity, preservative content and microbial limits, plus GMP and CoPP. State strength, gel or emulsion-gel, tube size and label language.