Pharmcokinetic Evaluation of Prednisolone SR Formulations Designed
K. V. R. N. S. Ramesh¹, K. Ravishankar² and A. Bharathi³¹Aditya Institute of Pharmaceutical Sciecnes.
²Sri Sai Aditya Institute of Pharmaceutical Sciences.
³Siddhartha College of Pharmaceutical Sciences, Surampalem - 533 437, East Godavari district India.
Corresponding Author E-mail:kantetiramesh@yahoo.com
Abstract: An in vivo pharmacokinetic study was performed in rabbits on prednisolone pure drug and a Sustained Relesase Formulation employing a more rapidly dissolving form of drug that was developed. A solution of prednisolone was used as reference standard. The products were given orally and at different time intervals blood samples were withdrawn and assayed for prednisolone content by reported HPLC method. From the plasma concentration time profiles the different pharmacokinetic parameters such as Cmax, Tmax, AUC, MRT, Kel, t1/2, Ka were calculated. While it was observed that in case of the pure drug the plasma concentrations (Cmax - 0.78 µg/ml ) were very low as also the AUC ( 7.6 µg-hr/ml), the solution form of the drug gave very high plasma concentrations of (Cmax - 4.15µg/ml ) and lower MRT values of 4.66 hrs , in the case of the sustained release formulations, the serum plasma concentrations (Cmax - 1.45 µg /ml; AUC – 20.67 µg-hr/ml ) were found to be intermediate between those obtained with solution form and the pure drug . Also the SR formulation gave serum concentrations that were stabilized and maintained over a narrow range and for longer periods. The relative bioavailability of prednisolone was found to be 92.25 % when compared to that of the solution taken as 100%.
Keywords: Pharmacokinetic; SR formulations Back to TOC