Suitability of limited sampling strategy to cyclosporine A oral formulation.

ABSTRACT

Therapeutic drug monitoring of cyclosporine A in renal transplant patients is normally performed by measuring pre-dose trough levels or doing area under the curve profiles from all possible sampling points. On the basis of good correlation between predicted area under the curve from limited sampling points and actual area under the curve (literature survey), a limited sampling strategy at 1, 3 and 5 hr was used and extended this strategy as a criteria for pilot evaluation of modified cyclosporine A formulations. Hemodialysis patients served as subjects for the study. Panimun Bioral was used as a test formulation while Sandimmun Neoral as standard reference. The study revealed that both formulations had similar restricted AUC0-5h profiles.