EFFECTS OF MEAL ON THE PHARMACOKINETICS OF FLUORIDE FROM ORAL MONOFLUOROPHOSPHATE

A two-treatment cross-over study was conducted on 8 Caucasian male hea lthy volunteers aged between 26 and 32 years in order to determine the influence of a standard meal on the bioavailability and pharmacokinet ics of fluoride after a single oral administration of tablets containi ng the equivalent of 10 mg fluoride as sodium monofluorophosphate (Na- MFP, CAS 10163-15-2) in a fixed combination with 300 mg Ca as calcium gluconate and calcium citrate. The meal provoked a significant delay o f the appearance of fluoride in blood (from 4 to 11 min), a slowing of the absorption rate, a prolongation of t(max) (from 34 to 146 min), a decrease of C(max) (from 369 to 122 ng/ml) and a prolongation of the Mean Residence Time (from 7.1 to 9.1 h). However, the amount of fluori de entering in the systemic circulation was not affected by the meal, as shown by the ANOVA on the AUC and on the cumulated urinary excretio n of fluoride in the 48 h following the administration of Na-MFP It is concluded that appropriate meals do not influence the amount of absor bed fluoride from Na-MFP, and that they modify the rate of absorption with pattern that may improve the safety and possibly also the efficac y of Na-MFP.