title: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Food and Drug Administration-Center for Drug Evaluation and Research, St. Louis, Missouri, USA. anna.wokovich@fda.hhs.gov
authors: Anna M
authors: AM
authors: Wokovich
authors: Meiyu
authors: M
authors: Shen
authors: William H
authors: WH
authors: Doub
authors: Stella G
authors: SG
authors: Machado
authors: Lucinda F
authors: LF
authors: Buhse
mesh_terms: D000268:Adhesiveness; D000279:Administration, Cutaneous; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004349:Drug Packaging; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D008774:Methylphenidate / Q000008:administration & dosage*; D057968:Transdermal Patch
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate