The amount of drug delivered into and through the patient’s skin is dependent, in part, on the surface area of the Transdermal or Topical Delivery System (collectively, TDS) dosed upon the skin. Under ideal conditions, the entire contact surface area of a TDS should remain consistently and uniformly adhered to the patient’s skin throughout the duration of wear. When a TDS loses its adherence during wear, the amount of drug delivered to the patient may be reduced. Thus, it is important to have tests that can monitor the adhesive properties and adhesion performance of TDS products. However, current laboratory (in vitro) tests that characterize aspects of TDS adhesive properties have limitations that make it challenging to correlate the test results with the in vivo adhesion performance of TDS. Thus, when differences are observed, it is challenging to know whether or not the difference will impact the clinical performance of the product.
The Center for Research on Complex Generics (CRCG) intends to form a Stakeholder Expert Committee (SEC) on Adhesion Testing for TDS, comprised of experts who can systematically consider the influence on adhesive properties and adhesion performance of intrinsic TDS attributes such as size and shape, as well as extrinsic factors that can impact TDS adhesion including temperature, torsion/flexion, time and other factors.
Individuals with an interest in serving on the SEC are invited to submit CVs and a letter of interest (LOI) by January 25, 2023, via email to firstname.lastname@example.org. The LOI should describe why they are interested in this topic and what they would have to contribute to research in this area, that will be funded by the CRCG (e.g., product development experience, dosage form expertise, in vitro testing or clinical adhesion assessment capabilities, TDS manufacturing capabilities, research innovation labs and instrumentation). CRCG seeks an SEC that is collectively composed of experts in TDS adhesion testing, where each committee member is not acting a representative of a group or a company, but an individual with expertise who is able to provide timely expert advice.
The SEC would work collaboratively with the CRCG and the FDA to consider the design of research that could develop improved in vitro test methods to evaluate the adhesive properties and adhesion performance of TDS. Once the research is awarded to a qualified research group, the SEC would continue to participate in routine progress meetings to discuss and advise on the ongoing research and development work. The CRCG plans to issue a Request For Proposals in Spring 2023. The SEC will not participate in proposal evaluation, and SEC membership itself will not be considered a conflict of interest to respond (submit a proposal) to the planned Request For Proposals.