Bioinequivalence of marketed diltiazem preparations.
A bioequivalence study of three brands of regular diltiazem--Angizem (A), Dilzem (B) and Herbesser (C) has been carried out in 5 healthy, male volunteers. After a single oral dose of 60 mg of each preparation, the mean AUC (0-8 h) and Cmax of preparation B was significantly higher than of brands A and C. The tmax of A and B was significantly lower than of C. B had a higher dissolution rate in vitro (98.8% dissolved in 45 min) than A and C. Thus, there was bioinequivalence of the three brands of diltiazem, due partly to differences in dissolution and perhaps in part to a first pass effect.
Joshi
M V
MV
Department of Pharmacology, Seth GS Medical College, Parel, Bombay, India.
Gokhale
P C
PC
Pohujani
S M
SM
Dalvi
S S
SS
Karandikar
S M
SM
Kshirsagar
N A
NA
D000328:Adult; D001682:Biological Availability; D004110:Diltiazem / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D007194:India; D008297:Male; D012995:Solubility; D013810:Therapeutic Equivalency
D004110:Diltiazem