Clinical pharmacological study of TTS-NTG in healthy volunteers. II. 48 Hours application.:48 Hours Application

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A transdermal. therapeutic system (TTS) containing nitroglycerin (NTG) was applied to 12 healthy male volunteers for 24 hours and 48 hours. Plasma NTG concentration was measured by capillary gas chromatography with electron capture detection using butane-1, 2, 4-triol-trinitrate as the internal standard. The mean plasma concentration over the intervals of 1-24 hours and 1-48 hours after application maintained a steady level throughout the application. The mean plasma level in the steady-state phase for the 48-hour application was similar to that for 24 hours. The notable subjective symptoms of TTS-NTG were generally reported as headache and/or heaviness of the head, but in the 48-hour application study, the incidence and intensity of these symptoms were reduced on the second day. The local irritation was well acceptable. Several subjects showed mild rubef action at the margin of the covered area of skin, but there was no difference between the 24-hour and 48-hour applications in the local irritation index. The residual amount of used system was analyzed by HPLC. The release rate of the system was 15.8±1.19μg/cm2·h (mean±S. E.) for the 24-hour, and 14.9±0.79μg/cm2·h (mean±S.E.) for the 48-hour application.
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