FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems

FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products.

The guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding the use of QbD during product design and manufacturing and throughout the product lifecycle, and recommends that scientific justification for the amount of residual drug be included in new drug applications.

The three-page draft provides an introduction and background and sections on quality by design, and “minimizing residual drug.”

[More on the FDA draft guidance and discussion of an EMA transdermal guidance concept paper now out for comment, along with relevant links, are provided for subscribers here.]