Pharmacokinetic studies on pulsatile drug delivery of natural non steroidal anti inflammatory drug: LC-MS/MS method

Abstract

The goal of this study was to explore variations in the pharmacokinetic patterns among a pulsatile drug delivery system using a pulsatile dosage forms (capsule and tablets), pure active pharmaceutical ingredient (curcumin) and an existing marketed immediate release formulation (conventional). The dosage form of 450 mg each were administered to 3 groups of white New Zealand Rabbits (n=6) following cross over design pattern and the plasma levels were measured using LC-MS/MS method. Pharmacokinetic parameters were determined for each dosage form. The comparison of the plasma time curves of the dosage forms showed that each dosage form caused significant differences in the drug plasma levels. The plasma drug profiles of active pharmaceutical ingredient and marketed conventional formulation of curcumin showed nearly similar pattern of drug release, whereas the pulsatile drug delivery systems showed a lag time of near about 4 hours before finally showing maximum concentration (Cmax) at near about12 hours, which correlated with the in-vitro release (12 hours).