Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Pharmacokinetic Study of Nifedipine in Healthy Adult Male Human Volunteers

M Ahmad¹ , T Ahmad², R A Sultan³, 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.

For correspondence:- M Ahmad Email: ma786_786@yahoo.com Tel:+92629255243

Received: 2 February 2009 Accepted: 12 June 2009 Published: 23 October 2009

Citation: Ahmad M, Ahmad T, Sultan RA, Murtaza G. Pharmacokinetic Study of Nifedipine in Healthy Adult Male Human Volunteers. Trop J Pharm Res 2009; 8(5):385-391 doi: 10.4314/tjpr.v8i5.2

© 2009 The authors.
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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 C_max (maximum plasma concentration), T_max (time to reach maximum plasma concentration), MRT (mean residence time), AUC_0-∞ (area under curve), AUMC_0-∞(area under first moment curve) and K_a (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. T_max was 1.58 h and C_max varied from 140 – 300 ng.mL^-1. Mean absorption rate constant was 2.22 h^-1while 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. AUC_0-_¥, AUMC_0-_¥ 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