Tecnalia's Pharmaceutical Development laboratory conducts the selection of the candidate polymers and topical antiseptics necessary to obtain a stable, safe and effective formula in the form of a transparent bioadjesive gel specific for the treatment of diabetic foot ulcers. It also carries out the PRODERMA analytical development and technological transfer along with the fine tuning, proper scaling and validation of production processes under GMPs, for which reason it will manufacture the validation batches for clinical testing while defining the final stability profile for the finished product.
Diabetic foot ulcerations are one of the main complications associated to diabetes mellitus. The latest WHO studies estimate that, by 2030, around 592 million people will be suffering from diabetes. The main purpose of the DFU treatments is to achieve healing for the injuries as fast as possible, preventing the onset of associated infections and the progression of wounds into more advanced phases. PRODERMA results, which are protected by international patents, will make it possible to obtain a competitive product with guarantees in a market segment with a turnover of more than 7 000 million euro yearly on the world scale.
The said segment covers products in the form of dressings and semi-solid antiseptic or healing formulas. Hence, PRODERMA will contain a multifunctional proposal of high added value in a single product that will enable improvements in the approach to ulcerative injuries and their treatment.
Proderma. Credit: Tecnalia
This collaboration aims at the development of a health product with healing properties combined with a topical antiseptic indicated for the treatment of diabetic foot ulcers, a disease affecting between 15 and 20% of diabetics that can lead to limb amputation. Currently to be found on the market are products such as dressings and antiseptic or healing formulas against diabetic foot ulcers. PRODERMA, on its side, strives for a proposal of combined multifunctional value in a single product that will enable improvements in the treatment of ulcerative injuries.
source: Elhuyar Fundazioa