Transdermal delivery patches often contain multiple materials, adhesives and inks which increase the risk of unwanted leaching of potentially harmful substances from these materials. Such substances may penetrate the skin barrier and into the patient. For this reason, strategically designed extractables and leachables (E&L) studies are of critical importance to the development of transdermal delivery products.

In this application note, Dr Tino Otte, Senior Scientific Consultant, Intertek Reinach, describes the steps required to implement and adapt an E&L study design for a transdermal delivery patch device.

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