Dermal Tolerance and Safety of an IFN-alfa Transfersome® formulation
J. Lehmann*, S. Nissen-Meyer*, S. Paul*, M. Klede+, A. Ikoma+,
M. Schmelz+, M. Rother*, G. Cevc*
*Medizinische Biophysik, Technische Universität München
Ismaningerstr. 22, D-81675 München, Deutschland, EU
+IDEA, Innovative dermale Applikationen GmbH, Frankfurter Ring 193a,
D-80807 München, Deutschland, EU
Skin and Environment - Perception and Protection. Proceedings
of 10th EADV Congress, Munich. (J. Ring, S. Weidinger, U. Darsow, eds.)
Monduzzi Editore, Bologna, 2001, pp:1031-1035.
Transfersomes® are a drug delivery system for macromolecules
consisting of ultra flexible, mixed lipid aggregates that penetrate the
skin driven by the transdermal hydration gradient. An IFN-alpha-2b Transfersome®
formulation was tested for its dermal tolerance and safety. The formulation
was tested in a preclinical irritation/corrosion study in rabbits as well
as in an observer-blinded, single-centre, placebo-controlled clinical
Phase I trial in 11 healthy volunteers. The formulation showed an excellent
safety profile after single dose administration in both studies.
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