ProductUpdated on 9 April 2025
TRAULEN - Diclofenac 4% - Cutaneous Spray Gel or Solution
About
The product is composed by a very special formulation containing Diclofenac sodium at a concentration of 4% as active principle and is used in the topical treatment of pain and inflammation of either rheumatic or traumatic origin in joints, muscles, tendons and ligaments.
It is packaged in a glass bottle on which it is mounted a spray pump: this differentiates the product among traditional gels and creams.
Before administration, the product appears as a liquid but when the spray pump is actuated, the resulting product which remains on the skin appears more like a gel.
This characteristic allowed the product to be registered all around the world either as gel and as solution.
Marketed in Italy since 1999, due to its prominent and documented efficacy, it has also established itself as alternative to oral treatment with NSAIDS.
The study of transcutaneous absorption of this particular formulation demonstrated both in the laboratory animal and in experimental "in situ" models made of human skin, a better tissue permeation compared to traditional topical formulations.
The dossier of TRAULEN is available in EU eCTD format; stability data are available even in IVb conditions.
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Federico Ponchiroli
Product manager at O.P. Pharma Srl
Milan, Italy
Service
Italy/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD
Federico Ponchiroli
Product manager at O.P. Pharma Srl
Milan, Italy