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Updated: May 26, 2026

Development, Characterization, and Evaluation of CAGE-based Ionic Liquid Systems for Transdermal Delivery
Published on: September 26, 2025
Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development
Glenn A Van Buskirk1, Daniel Arsulowicz, Prabir Basu
1Nonclinical Drug Development Consulting Services, LLC, Basking Ridge, New Jersey 07920, USA. vanbuskirk@drugdevconsult.com
Abstract:
In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems.
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