Evaluating elevated release liner adhesion of a transdermal drug delivery system (TDDS): A study of Daytrana™ methylphenidate transdermal system

Abstract

Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the release liner to such an extent that the release liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the release liner.

Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, release liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.

Results: TDDS from open chamber trays required less force to remove the release liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages examined), there were substantial differences in release liner removal force between an old lot and a new lot for closed chamber trays but not for open chamber trays.

Conclusion: The results demonstrate that for this particular TDDS, storage conditions such as humidity influence release liner adhesion. This project also demonstrates that, to ensure adequate product quality, adhesion needs to become an important design parameter, and the design of a TDDS should consider the ability to remove the release liner under anticipated storage conditions.

Keywords::

• Adhesion
• liner
• methylphenidate
• release liner
• patch
• transdermal delivery system

Acknowledgments

The authors thank the FDA CDER Office of Compliance Division of Compliance Risk Management & Surveillance (DCRMS) and the FDA Office of Regulatory Affairs (ORA) Miami office for their documentation assistance.

Declaration of interest

The authors thank the FDA Center for Drug Evaluation and Research (CDER) Regulatory Science and Review Enhancement (RSR) program for funding this project. This project relates with post-market product quality and safety issues, one of CDER’s FY 2008 priorities. This article reflects the current thinking and experience of the authors. The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy. The views presented in this article do not necessarily reflect those of Food and Drug Administration policy; this is not a policy document and should not be used in lieu of regulations, published FDA guidances or direct discussions with the agency. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. The information presented in this article is publically available; references are provided in the text.