Journal article
Determination of Rate and Extent of Scopolamine Release from Transderm Scop (R) Transdermal Drug Delivery Systems in Healthy Human Adults
AAPS PharmSciTech, Vol.21(3), pp.117-117
04/16/2020
DOI: 10.1208/s12249-020-01658-4
PMID: 32300962
Abstract
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.
Details
- Title: Subtitle
- Determination of Rate and Extent of Scopolamine Release from Transderm Scop (R) Transdermal Drug Delivery Systems in Healthy Human Adults
- Creators
- Suresh Kumar Swaminathan - University of MinnesotaCaroline Strasinger - United States Food and Drug AdministrationMegan Kelchen - University of IowaJamie Carr - University of Iowa Hospitals and ClinicsWei Ye - United States Food and Drug AdministrationAnna Wokovich - United States Food and Drug AdministrationPriyanka Ghosh - Center for Drug Evaluation and ResearchSrinivasan Rajagopal - Roy J. and Lucille A. Carver College of MedicineKenichi Ueda - Roy J. and Lucille A. Carver College of MedicineJames Fisher - Analytical ServicesKarunya K. Kandimalla - University of MinnesotaNicole K. Brogden - University of Iowa Hospitals and Clinics
- Resource Type
- Journal article
- Publication Details
- AAPS PharmSciTech, Vol.21(3), pp.117-117
- Publisher
- Springer Nature
- DOI
- 10.1208/s12249-020-01658-4
- PMID
- 32300962
- ISSN
- 1530-9932
- eISSN
- 1530-9932
- Number of pages
- 10
- Grant note
- 5U01FD004275 / National Institute for Pharmaceutical Technology and Education U01 Critical Patch Manufacturing Sector Research Initiative CTSA U54TR001356 / NIH/NCATS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS)
- Language
- English
- Date published
- 04/16/2020
- Academic Unit
- Dermatology; Pharmaceutical Sciences and Experimental Therapeutics; Anesthesia
- Record Identifier
- 9984295957602771
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