Comparison of pharmacokinetics of two preparations of cyclosporine in end stage renal disease patients on maintenance haemodialysis

To compare the pharmacokinetics and tolerability of two preparations of cyclosporine. The bioavailability of two preparations of cyclosporine [Panimun Bioral, Panacea Biotec India and Sandimmun Neoral, Novartis Switzerland] was compared in 10 adult patients of ESRD on maintainence haemodialysis by enzyme multiplied immunoassay technique [EMIT] after 6.5 days of cyclosporine [5 mg/kg body weight/day in two divided doses] of either brand, with a clearance period of one week in between the two. Area under the curve [AUC], maximum whole blood concentration [Cmax], time to achieve Cmax [Tmax], half life [T1/2], constant of elimination [Kel] was calculated by computer software programme [PK Solutions]. The relative bioavialability of Panimun Bioral was 93%. The AUC [0-12] hours. Cmax Tmax, T1/2 and Kel was not statistically significantly different and side effects with both were minimal. The two preparation were bioequivalent