Determination of Rate and Extent of Scopolamine Release from Transderm Scōp® Transdermal Drug Delivery Systems in Healthy Human Adults

Suresh Kumar Swaminathan, Caroline Strasinger, Megan Kelchen, Jamie Carr, Wei Ye, Anna Wokovich, Priyanka Ghosh, Srinivasan Rajagopal, Kenichi Ueda, James Fisher, Karunya K. Kandimalla, Nicole K. Brogden

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1 Scopus citations


To estimate strength of a scopolamine transdermal delivery system (TDS) in vivo, using residual drug vs. pharmacokinetic analyses with the goal of scientifically supporting a single and robust method for use across the dosage form and ultimately facilitate the development of more consistent and clinically meaningful labeling. A two-arm, open-label, crossover pharmacokinetic study was completed in 26 volunteers. Serum samples were collected and residual scopolamine was extracted from worn TDS. Delivery extent and rate were estimated by (1) numeric deconvolution and (2) steady-state serum concentration determined from graphical and non-compartmental analyses. In residual drug analyses, mean ± SD scopolamine release rate was 0.015 ± 0.002 mg/h (11% RSD), vs. 0.016 ± 0.006 mg/h (35% RSD) from numeric deconvolution, 0.015 ± 0.005 mg/h (34% RSD) from graphical analysis, and 0.015 ± 0.007 mg/h (44% RSD) from non-compartmental analysis. In residual drug analyses, total drug released was 1.09 ± 0.11 mg (10% RSD), vs. 1.12 ± 0.40 mg (35% RSD) from numeric deconvolution, 1.07 ± 0.35 mg (33% RSD) from graphical analysis, and 1.07 ± 0.45 (42% RSD) from non-compartmental analysis. Extent and rate of scopolamine release were comparable by both approaches, but pharmacokinetic analysis demonstrated greater inter-subject variability.

Original languageEnglish (US)
Article number117
JournalAAPS PharmSciTech
Issue number3
StatePublished - Apr 1 2020

Bibliographical note

Funding Information:
This project was funded by the following grants: National Institute for Pharmaceutical Technology and Education U01 Critical Patch Manufacturing Sector Research Initiative (5U01FD004275), and NIH/NCATS CTSA U54TR001356.

Publisher Copyright:
© 2020, American Association of Pharmaceutical Scientists.


  • pharmacokinetics
  • scopolamine
  • transdermal


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