PQRI DTC 2022 Webinar: Extractables and Leachables Testing for Transdermal Delivery Systems

PQRI DTC 2022 Webinar:  Extractables and Leachables Testing for Transdermal Delivery Systems

November 2, 2022

To view a recording of the webinar, click here.

This webinar focused on regulatory and scientific challenges associated with the execution of extractable and leachable (E&L) studies for transdermal delivery systems and explore how the principles of safety thresholds developed for inhaled and parenteral drug product container closure systems may be applied similarly for transdermal delivery systems E&L studies.

Transdermal delivery systems (TDS) are designed to deliver an active ingredient (drug substance) across the skin and into the systemic circulation. As with all high-risk dosage forms, TDS must be evaluated for potential extractables that could be drawn out of the product components by a solvent system or introduced during manufacturing as well as leachables that could be introduced from packaging into the adhesive matrix.  FDA’s expectations for these studies are described in the 2019 draft guidance, “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations: Guidance for Industry”. However, there has long been a desire across the pharmaceutical industry to adopt a standardized approach and/or framework for these complex studies and assessing the risks.

To that end, in 2006, the Product Quality Research Institute’s (PQRI) Leachables and Extractables Working Group released a comprehensive and detailed recommendation document detailing best pharmaceutical development practices regarding container closure/delivery system component composition and selection, controlled extraction studies, drug product leachables studies, and routine extractables testing for component release for inhalation drug products. Also included in the document are two safety-based thresholds for leachables in inhalation drug products, the qualification threshold (QT) and the safety concern threshold (SCT), the first such safety-based thresholds for leachables in any drug product type. In 2008, building on the same principles, the working group released a similar recommendations document for parenteral and ophthalmic drug products (PODP) and after many years of work, released in October 2021, Safety Thresholds and best Demonstrated Practices for E&L in Parenteral Drug Products (Intravenous, Subcutaneous, and Intermuscular) and a companion document that summarized years of studying E&L in the niche filed of ophthalmic drug products (OPD) Principles for Management of E&L in OPD.  Given their similar level of risk as OINDP and PODP, it is reasonable to hypothesize that best practices suitable for OINDP and PODP could be applicable to TDS; that is, many of the concepts developed in the recommendations for OINDP and PODP could be adapted to and customized for TDS.  However, it is recognized that there is an added complexity when dealing with TDS components and systems versus packaging component and systems utilized to package OINDP and PODP. In this webinar, we invite TDS experts from FDA and industry to share their experiences and participate in a panel discussion on the challenges and considerations for developing extractables and leachables safety thresholds for TDSs.

Moderators:

• • Desmond Hunt, Ph.D., Senior Principle Scientist, U.S. Pharmacopeial Convention (USP)
  • Meenal Chavan, Ph.D., Senior Pharmaceutical Quality Assessor, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), CDER, FDA

Speakers:

• • Cedar Boakye, Ph.D., Drug Product Quality Assessor, OLDP, OPQ, CDER, FDA
  • Gyorgy Vas, Ph.D., Business Technical Scientific Liaison, Intertek Pharmaceutical Services

Click here to view the Moderator and Speaker bios.

Webinar Program and Abstracts