February 202019MANUFACTURING TECHNOLOGY INSIGHTSTransdermal drug delivery systems (TDDS) are combination products classified as such due to their dual function as medical devices and pharmaceuticals. For example, medical device characteristics of a TDDS include adherence to the user for the duration of the wear time, control of adhesive flow from the perimeter of the system while in use (cold flow), and occlusion of the drug-containing system to prevent unintended exposure. Pharmaceutical characteristics of a TDDS include product potency and drug delivery rate, for example. To maintain the integrity of these complex combination systems, the developers of the system must explicitly define what attributes are critical to the quality (i.e., blend uniformity, patch dimensions, or patch delivery rate). It is the responsibility of the manufacturer to ensure then they can control their process appropriately to maintain these product critical quality attributes (CQA). A Quality by Design (QbD) approach to TDDS development ensures that the critical process parameters (CPP's) A Quality Approach to Coating Transdermal Delivery DevicesCXO INSIGHTSBy Robert Lambert, Director of Manufacturing Technical Services, Noven Pharmaceuticals
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