FDA Recommends 5-Point Scale for Evaluating Topical Patch Adhesion

Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says.

In draft guidance released Tuesday, the agency recommends that drugmakers evaluate the adhesion of the reference product and the test products at a series of time periods throughout the clinical study with a five-point numerical scale.

The purpose of the scale is to determine whether the entire surface area of the topical patch adheres to the skin for the duration of wear, the FDA says.