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Research
Article
Pharmacokinetic Study of Nifedipine in Healthy Adult
Male Human Volunteers
M Ahmad1*,
T Ahmad2, RA Sultan3 and
G Murtaza1
1Department
of Pharmacy, Faculty of Pharmacy and Alternative
Medicines, The Islamia University of Bahawalpur,
Bahawalpur 63100, 2HEJ Research Institute of
Chemistry, University of Karachi, Karachi, 3Faculty
of Pharmacy, University of Karachi, Karachi, Pakistan.
*Corresponding author:
E-mail:
ma786_786@yahoo.com
Tel: +92-62-9255243, 300-9682258 (cell); Fax:
+92-62-9255565
Received: 2
February 2009
Revised accepted:
12 June 2009
Tropical
Journal of Pharmaceutical Research, October 2009; 8(5):
385-391
Abstract
Purpose:
To evaluate the pharmacokinetics of nifedipine in
healthy adult Pakistani subjects.
Methods:
Each of six fasting volunteers received 20 mg nifedipine
(2 x Adalat® 10 mg capsules) orally once and
then another one week later. Their blood samples were
obtained at regular time intervals and analysed by HPLC.
Using the non-compartmental approach, plasma levels of
nifedipine were employed to compute their individual
disposition kinetics, including Cmax (maximum
plasma concentration), Tmax (time to reach
maximum plasma concentration), MRT (mean residence
time), AUC0-∞ (area under curve), AUMC0-∞
(area under first moment curve) and Ka
(absorption rate constant).
Results :
The suggested therapeutic level of nifedipine for the
treatment of hypertension (15-35 ng.mL-1) was
achieved in all six volunteers within 0.25 h after dose
administration, and maintained for more than 6 h. Tmax
was 1.58 h and Cmax varied from 140 – 300
ng.mL-1. Mean absorption rate constant was
2.22 h-1 while mean absorption half-life was
0.43 h. The mean elimination rate constant was 0.16 h-1
while 5.7 h was recorded for terminal half-life. AUC0-¥,
AUMC0-¥
and MRT were 1879.86 ng.h.mL-1, 8244.04 ng.h2.mL-1
and 4.2 h, respectively.
Conclusion:
This study confirms the rapid absorption of nifedipine
in humans. AUC was similar to that previously reported
for Nigerians but slightly lower than that stated in the
literature for other south Asian races. Further studies
on large segments of the local population using the
non-compartmental model for kinetic analysis is
recommended.
Keywords:
Nifedipine;
Pharmacokinetics; Non-compartmental model; Pakistani
subjects. |
