A current project is the production of a medicinal product to treat leishmaniasis - a widespread facial deformity. These skin lesions are caused by the bites of female "sandflies", which transmit the Leishmania parasites when drawing blood.
To treat this, Waisenmedzin developed the product Leiprotect® - the medicinal product has since been approved by the Federal Institute for Drugs and Medicinal Products (BfArM). Leiprotect® is a gel that seals the wound with a protective film.
Preparation of the gel poses a technical challenge: During mixing of the dry and liquid gel components via agitation in the conventional manufacturing process, a lot of air is introduced into the preparation. These air pockets prevent the gel from sealing the wound with a dense film after drying out. Therefore, the product requires downstream degassing, however this volatilises one of the active ingredients, thus rendering the product ineffective.
With the support of ystral gmbh, a machine and systems construction company focused on process engineering from Ballrechten-Dottingen near Freiburg, a manufacturing process has been developed which makes it possible to omit the downstream degassing process during production of LeiProtect® gel . By using a special powder wetting process under short-term vacuum, it is possible to prevent entry of unwanted air from the start. This collaboration initiated by the lead physician and researcher Prof. Dr. Dr. K.-W. Stahl resulted in the donation of the PiloTec processing plant by the ystral gmbh, which was required for production.
YSTRAL PiloTec is a processing plant especially developed for small quantities (5-50 litres per batch), which features the YSTRAL Conti-TDS-1 and an YSTRALJet Stream Mixers and meets the requirements of CE certification for the manufacture of medicinal products. The process plant is now installed in the pharmacy of University Hospital Erlangen and will enable the production of Leiprotect® just in time for the coming disease season.