ISSN:
1437-160X
Keywords:
Key words Cyclosporin A
;
Sandimmun Neoral
;
Pharmacokinetics
;
Rheumatoid arthritis
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract In this study we aimed at evaluating the modifications in the pharmacokinetic profile of cyclosporin A (CyA) after conversion from standard formulation (CyA-ST) to a new formulation (CyA-NF, Sandimmun Neoral) in patients with rheumatoid arthritis (RA). It was an open, crossover study that involved 15 RA patients who were on stabilized treatment with CyA-ST. The patient continued receiving CyA-ST (mean dose of 3.0±0.7 mg/kg per day) for 3 weeks and then converted 1:1 to CyA-NF for a further 3 weeks. CyA pharmacokinetics were established on day 1 (CyA-ST evaluation) and +21 (CyA-NF evaluation). The results showed that the bioavailability of CyA-NF was greater than that of CyA-ST (AUCτ, bss: 3335±1300 vs 2667±1155 ng ⋅ h/ml, P=0.0073; AUCτ, bss ratio 1.26±0.40 vs 1.0 as reference, P〈0.05), with higher and earlier peak blood concentrations (C max: 677±256 vs 475±213 ng/ml, P=0.0329; t max: 1.5±0.7 vs 2.6±1.6 h, P=0.0720). The pharmacokinetic profile of CyA-NF showed greater between-patient reproducibility (lower CV% for all of the considered parameters). In conclusion, when using CyA-NF instead of CyA-ST, greater and more constant exposure to CyA should be expected.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/s002960050034
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