NDLI: A Unique Iontophoretic Patch for Optimal Transdermal Delivery of Sumatriptan

Content Provider	Springer Nature Link
Author	Siegel, Steven J. O’Neill, Carol Dubé, Louise M. Kaldeway, Peter Morris, Russell Jackson, David Sebree, Terri
Copyright Year	2007
Abstract	Migraines affect approximately 10% of the adult population worldwide. The purpose of this study was to assess the pharmacokinetic and safety profile of a novel iontophoretic sumatriptan delivery system, NP101, which uses an electrical current to propel sumatriptan across intact skin and into underlying tissue. Four unique prototype iontophoretic sumatriptan patch conditions were compared to a 6 mg subcutaneous injection and an oral 50 mg tablet of sumatriptan succinate.This was a randomized, single-center, single-dose, six-period Phase I study.Patches were well tolerated with fewer adverse events than the subcutaneous injection. Adverse events that were more prevalent for NP101 than other formulations included localized sensations and reactions at the patch site. A linear relationship was observed between total applied current and sumatriptan delivery. Patches delivering 6 and 12 mA per h yielded favorable sumatriptan systemic profiles, delivering drug at a rate that maintained plasma levels above the target level (≥10 ng/ml) for greater than 7 h.This study met the initial objective to define the dose–current relationship in humans as well as delimiting specific current and current density targets for a well tolerated patch design that can deliver therapeutic drug levels for longer periods than currently possible.
Starting Page	1919
Ending Page	1926
Page Count	8
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	24
Issue Number	10
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2007-06-19
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	clinical trial iontophoresis migraine phase I sumatriptan Biomedical Engineering Medical Law Biochemistry Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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