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Administration diluents differentiate Neoral from a generic cyclosporine oral solution
Author(s) -
Kovarik John M,
Barilla Denise,
McMahon Louis,
Wang Yibin,
Kisicki James,
Schmouder Robert
Publication year - 2002
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1034/j.1399-0012.2002.02011.x
Subject(s) - bioequivalence , medicine , orange juice , bioavailability , cmax , pharmacokinetics , crossover study , oral administration , pharmacology , grapefruit juice , chromatography , food science , placebo , chemistry , alternative medicine , pathology
A non‐microemulsion cyclosporine oral solution was recently recalled from the market because of the lack of bioequivalence when administered with apple juice compared with water as the diluent. This open‐label, randomized, two‐period, crossover study assessed the effect of apple juice on Neoral, a microemulsion cyclosporine oral solution. The study enrolled 34 subjects who received 180 mg Neoral oral solution diluted in 200 mL tap water or apple juice. Cyclosporine was measured in whole blood by a liquid chromatography method. Pharmacokinetic parameters were compared by standard bioequivalence tests. With water vs. apple juice, cyclosporine C max was 1263 ± 203 vs. 1191 ± 225 ng/mL and AUC was 4714 ± 1117 vs. 4788 ± 1320 ng h/mL, respectively. Bioequivalence was demonstrated for both parameters. These data were comparable with those from a previous study in which subjects received 180 mg Neoral oral solution with orange juice. Cyclosporine bioavailability is unaltered when Neoral is administered diluted in apple juice or orange juice compared with tap water which conforms to the cyclosporine product label.