Comparison of the steady state pharmacokinetics of two formulations of cyclosporin in patients with atopic dermatitis*

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Abstract
A comparison was made of the efficacy, tolerability, safety and steady state pharmacokinetics of Sandimmun® in 11 stable atopic dermatitis patients already on Sandimmun®. The study was of an open, crossover design. At entry into the trial, patients were switched to Neoral® for 28 days. Treatment was switched back to Sandimmun® for Days 28 to 42. The morning dose was given fasting, the evening dose after a standard meal. Al measures of eczema severity improved during the Neoral® treatment period. Neoral® was markedly better tolerated with fewer side‐effects. Switching from Sandimmun® to Neoral® at the same dose resulted in less variable pharmacokinetic profiles in both fasted and fed states. There was an increase in bioavailability with better, less variable and faster absorption, with a slightly reduced tmax, a higher mean Cmax (+43%) and a higher mean AUC (+30%) in fasted, but not fed patients. Higher trough levels (Cmin) occurred throughout for Neoral® These differences between the two formulations were not associated with any changes in safety parameters. Overall, Neoral® was equivalent or superior to Sandimmun® in tolerability and efficacy when given on a 1:1 dose basis.