The pharmacokinetics and acute renal effects of oral microemulsion ciclosporin A in normal pigs

International Immunopharmacology
D CibulskyteJ Mortensen

Abstract

The use of ciclosporin A (CsA) is limited by nephrotoxicity. Anatomic and physiologic similarities to humans make the pig a potential important animal model for research in effects and adverse events of CsA. In a long-term study CsA 10 mg/kg/day for 6 months did not cause deterioration in renal histology or function in pigs. For ideal CsA dosage in future long-term studies of nephrotoxicity we performed this study to describe pharmacokinetics and acute effects on renal function of CsA in normal pigs. Three groups of 5 piglets comprised the material, a control group and 2 groups receiving 5 days treatment with CsA (Neoral) 15 or 30 mg/kg/day, respectively. CsA whole blood concentration (B-CsA) (hourly), renal blood flow, glomerular filtration rate (GFR) and serum creatinine were measured. The area under the curve from time 0 to 12 h was calculated using the Trapezoidal Rule. Pharmacokinetic calculations were performed using the KINFIT non-linear curve fitting module. B-CsA reached peak in median at 0.90 and 0.96 h (633 and 914 ng/ml) in the 15 and 30 mg/kg/day groups, respectively, and median AUC was 5055 and 6275 h ng/ml, respectively. Trough levels were 338 and 475 ng/ml. The distribution of CsA followed a 2-compartment model....Continue Reading

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Citations

Nov 28, 2012·Pharmaceutical Research·Claudia Suenderhauf, Neil Parrott
May 17, 2014·Journal of Cardiovascular Translational Research·S J Jansen Of LorkeersS A J Chamuleau
Feb 16, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Melissa GuadaMaria J Blanco-Prieto
Dec 22, 2007·Expert Opinion on Drug Delivery·H Yesim Karasulu
Oct 31, 2014·Immunopharmacology and Immunotoxicology·Hua PanMauricette Michallet
Jan 13, 2018·International Journal of Molecular Sciences·Sergio Luis-LimaEsteban Porrini
Jan 30, 2007·Nephron. Experimental Nephrology·Donata CibulskyteJens Mortensen

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