Abstract

PHARMACOKINETICS AND PK/PD MODELING OF AMOXICILLIN IN HUMAN MALE AND FEMALE VOLUNTEERS

Naima Batool, Neelam Iqbal, Mehak Gull and Zahid Manzoor*

ABSTRACT

The present study aimed to investigate the pharmacokinetic behavior in terms of Pharmacokinetic(PK)/Pharmacodynamic (PD) Modeling of amoxicillin in human male and female volunteers. For this purpose, ten healthy, adult male and ten healthy adult females of 20-25 years of age were randomly selected. The detailed study procedure was told to the each human volunteer and consent was taken from each individual prior to the study. Amoxicillin (500 mg capsule) was administered orally to each volunteer. Blood samples were collected at specific time intervals. Plasma drug concentrations and time data was subjected to WinNonlin® for the estimation of pharmacokinetic parameters. Based upon the pharmacokinetic and pharmacodynamic data, PK/PD indices were estimated in order to optimize the dosage regimen of amoxicillin in humans. Student’s T-test was applied to observe the significant difference of the pharmacokinetic parameters between male and female human volunteer. P < 0.05 was considered as significant. Amoxicillin was well distributed in the body after its absorption as indicated by their respective AUC values in both male and female human volunteers. However, the drug was slowly eliminated (P < 0.05) in human female volunteers and stayed in the body for longer period of time as compared to human male volunteers. The values of PK/PD indices fall below the recommended values suggesting the individual dose optimization of amoxicillin in humans.

Keywords: Amoxicillin, Human volunteers, Pharmacokinetics, PK/PD Modeling.