PHARMACOKINETICS OF A NEW MICROEMULSION FORMULATION OF CYCLOSPORINE-A(NEORAL) IN YOUNG-PATIENTS AFTER RENAL-TRANSPLANTATION

Pharmacokinetics of the new galenic formulation of cyclosporin A, Neor al, (Sandoz) was examined in 12 stable young patients after renal tran splantation. Six of these patients were tested before and 4 weeks afte r switching from the standard formulation Sandimmun to Neoral. No sign ificant changes were observed in trough levels, t(max), C-max, and AUC (0-12h), but the absorption rate constant (K-a) increased (P = 0.03). Glomerular filtration rate, as assessed by inulin clearance, increased by more than 10% in three patients and decreased in two, and was usua lly associated with a respective drop and rise in C-max and AUG(0-12h) , of cyclosporin A. The large interindividual variability in the respo nse to the conversion to the new formulation points to a need for clos e monitoring of cyclosporin A trough levels and renal function after s witching from Sandimmun to Neoral in this age group in order to avoid nephrotoxicity.