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Related Experiment Videos

Dose proportionality of transdermal nitroglycerin.

R C Jewell1, C R Banfield, D A Ruggirello

  • 1Schering-Plough Research, Miami, Florida.

Pharmaceutical Research
|October 1, 1992
PubMed
Summary

This study measured plasma nitrate levels from transdermal nitroglycerin patches. Results show dose proportionality for nitroglycerin metabolites but not for nitroglycerin itself at higher doses.

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Area of Science:

  • Pharmacology
  • Drug Metabolism
  • Clinical Pharmacology

Background:

  • Previous FDA Cooperative Efficacy Study of transdermal nitroglycerin lacked plasma concentration data.
  • Understanding transdermal nitroglycerin pharmacokinetics is crucial for optimizing therapeutic use.

Purpose of the Study:

  • To assess plasma nitrate concentrations following various transdermal nitroglycerin doses (15, 30, 60, 105 mg/24 hr).
  • To evaluate dose proportionality of nitroglycerin and its metabolites in plasma.

Main Methods:

  • Employed the FDA Cooperative Study design with transdermal nitroglycerin doses.
  • Measured plasma concentrations of nitroglycerin, 1,3-glyceryl dinitrate, and 1,2-glyceryl dinitrate over 24 hours and 1 hour post-removal.
  • Normalized data by theoretical dose to assess dose proportionality.

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Main Results:

  • Dose-normalized Cmax and AUC(0-infinity) for nitroglycerin were higher at the 105 mg/24 hr dose.
  • No significant differences in dose-normalized Cmax or AUC(0-infinity) were observed for dinitrate metabolites across doses.
  • Time to maximum concentration (Tmax) did not differ between dose levels for all analytes.

Conclusions:

  • Dose proportionality was observed for 1,3-glyceryl dinitrate and 1,2-glyceryl dinitrate from 15 to 105 mg/24 hr.
  • Nitroglycerin plasma concentrations demonstrated linear pharmacokinetics only between the 15 and 60 mg/24 hr dose range.