Clinical Pharmacokinetics of Mianserin Suppositories in Healthy Older Japanese Male Adults: A Pilot Study

Abstract

Mianserin suppositories were formulated to treat symptoms of delirium and depression. Pharmacokinetics were assessed by measuring blood concentrations of mianserin in healthy older Japanese male adults. The effects of 20 mg mianserin suppositories were evaluated in three healthy older male adults. Mianserin concentration in blood was measured using gas chromatography-mass spectrometry. t_max was 14.7±8.1 h; C_max was 7.0±1.4 ng/mL; AUC₀₋₄₈ was 196.7±19.6 h・ng/mL; and AUC_0−∞ was 264.9±38.3 h・ng/mL. Compared to young male adults, older male adults demonstrated delayed t_max, lower C_max, and lower AUC_0−∞, suggesting a lower absorption rate through the rectal mucosa. These results demonstrate differential pharmacokinetics of mianserin suppositories in younger versus older adult men.