Join PDA Mountain States and Boston Analytical's, Eric Hill in an informative discussion on how transdermal patches are used to incorporate the drug's active ingredient into the circulatory system through the skin. Transdermal products are gaining popularity in the industry due to their ease of use; however, they present unique leachables concerns compared to traditional drug products. Transdermal products incorporate a backing layer, release liner, and storage pouch that all can serve as sources of leachables to the patient during the transdermal patch administration. Transdermal patches come in two forms – drug in adhesive patches and drug in reservoir patches. Both types of patches present unique challenges for analysis. The U.S. Food and Drug Administration (FDA) Guidance for the industry has categorized transdermal patches as a packaging type with a high concern associated with the route of administration. The FDA has specifically requested leachables studies be performed for transdermal patch products, which include methodologies that mimic skin-contact during typical usage, including exercise conditions. The design of suitable leachables studies that mimic "in-use" conditions is very challenging. Herein, the strategies for evaluating extractables & leachables in transdermal patches will be discussed. This will include the sweat and skin-contact simulation studies based on a single-side extraction to mimic the skin-contact under exercise conditions in the worst-case clinical usage.
Our sponsored webinar by Boston Analytical covers the attendance cost but advance registration is required. Register today to get your access credentials. We look forward to providing you an enlightening experience and to hearing you on the call!