Polyurethanes as self adhesive matrix for the transdermal drug delivery of testosterone

Abstract

The new technology to manufacture transdermal active patches without solvents or increased temperatures described here is based on polyol and isocyanate reacting to polyurethane (PU) in the presence of the drug. The technology was proven using testosterone (T) as the drug and N,N-Diethyl-m-toluamide (DEET) and Limonene (L) as enhancers for skin permeation. The experimental patches varied in drug content and enhancer concentration. The patches were evaluated regarding adhesion to stainless steel or leather, in vitro drug release and T permeation across human cadaver skin using Franz cell. Comparing the results with those of a parallel investigation of the commercial product, Testopatch^®, adhesion to leather and in vitro drug release of the experimental patches were found to be higher. The steady-state flux (J_SS) of T from the experimental patches was found lower than Testopatch^®. The flux of the experimental patch P3, which had the highest concentration of DEET and a low concentration of L was comparable to J_SS of the commercial product, Testopatch^®.

Keywords::

• Polyurethane
• adhesive
• transdermal
• testosterone
• permeation

Acknowledgement

The authors wish to thank F. Köpps for his support within the lab, and sincere thanks are given to Dr. Jutta Kalbitz for her analytical support as well Dr. Udo Bock and his coworkers for their support in skin permeation studies. The work was granted by Otto Bock Kunststoff Holding GmbH, Duderstadt, Germany.

Declaration of interest

The authors are employees¹ or consultants² of Otto Bock Kunststoff Holding GmbH, Duderstadt, Germany, and the work published here was financed by this company. However, the authors alone are responsible for the content and writing of this paper.