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Pharmaceutical Manufacturing and Packing Sourcer

Transdermal Delivery Systems

Transdermal delivery systems (TDS) are complex combination products typically composed of multilayer polymer components designed to deliver drugs systemically. As a result of their complex design and unique dosing requirements, designing and executing extractable and leachable (E&L) studies can be a unique challenge. One of the biggest hurdles has been the overall lack of direct regulatory guidance in the development of study designs requiring the sponsors of drug products to make regulatory justifications. Until recently, the main regulatory guidance for E&L for container/closure systems was the 1999 guidance, which included the table that correlates the likelihood that leachables would occur and the risk associated with the route of administration – which clearly ranks transdermal delivery systems as a high risk for both the potential for leachables and the route of administration (1).

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About the author

Dr Wayland Rushing has 20 years of chemical, manufacturing, and controls (CMC) analytical testing experience, including over 15 years of experience in E&L programmes. As the Director of Scientific Affairs, he is responsible for designing and implementing CMC testing programmes for Eurofins clients, including E&L programmes for pressurised metered dose inhalers, dry powder inhalers, nebulisers, and prefilled syringes, along with a variety of other drug delivery and container/closure systems. He earned his Bachelor’s degree from Westminster College, US, and his PhD in Chemistry from the University of Missouri, US.
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