ASSESSMENT OF HUMAN CADAVER AND RECONSTRUCTED SKIN MODELS TO PREDICT PHARMACOKINETICS OF TESTOSTERONE TRANSDERMAL DRUG DELIVERY PATCHES.0

• TR Number: 238
• Authors: Myszka1, S.L.W., Husberg1, M.L., Lawton1, J.M., Lippert1, D.R., Harrison2, L.I. 13M Drug Delivery Systems Division, St. Paul, MN, USA, 55144, 23M Pharmaceuticals Division, St. Paul, MN, USA, 55144.

Testosterone TDD patches were compared for in-vitro skin permeation characteristics and in the clinic for in-vivo pharmacokinetic parameters. In-vitro evaluations were conducted using both human cadaver and reconstructed skin models in order to determine a model predictive of in-vivo delivery. HCS was chosen at the model most predictive of testosterone in-vivo delivery. The preliminary IVIVC using HCS is very strong (r=0.99971).