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Angiology
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Nitroglycerin Concentration in Plasma: Comparison Between Transdermal Therapeutic System and Ointment

Li-chiang Chu

ALZA Corporation, Palo Alto, California

Robert M. Gale

ALZA Corporation, Palo Alto, California

Leonore G. Schmitt

ALZA Corporation, Palo Alto, California

Jane E. Shaw

ALZA Corporation, Palo Alto, California

This double-blind cross-over study evaluates in 12 male volunteers the time course of nitroglycerin concentration in plasma with use of the TTS-nitroglyc erin, a controlled-release transdermal dosage form for nitroglycerin, and com pares the bioavailability of nitroglycerin delivered from the transdermal system with that from three successive applications of 0.5 inch of 2% nitroglycerin ointment placed at 8 hr intervals over 10 cm 2 of skin. The mean amounts of nitroglycerin available when subjects wore the TTS-nitroglycerin or received successive applications of ointment were 15.8 mg ± 1.8 (SE) and 9.8 mg ± 0.8, respectively. Mean plasma concentrations for both treatments ranged from 10- 18 pg/ml-cm2. The normalized areas under the curves — 353 and 410 pg/hr/ml cm2, respectively — did not differ significantly. The ratio of clearance from the two dosage forms was 0.98±0.12. All subjects experienced mild-to-moderate side effects of nitrate therapy with both dosage forms and also decrease in blood pressure and increase in heart rate.

Angiology, Vol. 35, No. 9, 545-552 (1984)
DOI: 10.1177/000331978403500901
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