Abstract

A SIMPLE NON-INVASIVE COMPARATIVE LOG LINEAR PK-PD MODEL OF DEXIBUPROFEN TABLETS IN INDIAN HEALTHY HUMAN MALE VOLUNTEERS

Punnamchand Loya* & Madhusudan N. Saraf

Abstract

The aim of the present work was to develop a simple PK-PD model for NSAIDs taking dexibuprofen as a study drug. In this study, the pharmacokinetics and pharmacodynamics of dexibuprofen were investigated in Indian healthy volunteers during a fasting state for over 10 h. The pharmacodynamic study was carried by checking the inhibition of methyl nicotinate (MN) induced erythema after a single oral administration of 400 mg tablets of dexibuprofen using Laser Doppler Flowmeter (LDF) for a period of 12 h. In addition, the concentration of dexibuprofen in blood samples was determined by HPLC. The time courses of the plasma concentration of dexibuprofen and the % inhibition of methyl nicotinate (MN) induced erythema were analyzed. It was found that there exists a direct relation between concentration-effect of dexibuprofen. Hence a simple log linear PK-PD was applied and the applied PK-PD model helps in predicting the clinical performance of new NSAID formulations.

Keywords: Dexibuprofen, HPLC-UV, LDF, Human Volunteers & Log-Linear PK-PD.