Περίληψη:
In the present investigation, it was explored whether food effect on
drug absorption in adults is similar with the food effect after
administration of an infant meal with the drug product to adults. After
confirming lack of pharmaceutical and pharmacokinetic interaction, a
paracetamol suspension and an ibuprofen suspension were co-administered
to eight healthy adults on a crossover basis in three different
occasions, i.e. in the fasted state (as defined by regulatory agencies,
fasted conditions), in the fed state (as defined by regulatory agencies,
fed conditions) and under conditions simulating the fed state in infants
(infant fed conditions). Unlike under fed conditions, under infant fed
conditions early exposure was significantly lower than under fasted
conditions for both paracetamol and ibuprofen. Also, for ibuprofen,
C-max values under infant fed conditions were significantly higher than
under fed conditions. These data suggest that, even for drugs with
non-problematic absorption administered in simple dosage forms, food
effects in infants may not be adequately evaluated if the protocol
suggested by regulatory agencies is applied. The usefulness of the
methodology employed in the present investigation for simulating the fed
state in infants deserves further evaluation. Until then, food effects
in infants should be considered cautiously or be evaluated in infants.
Συγγραφείς:
Statelova, Marina
Goumas, Konstantinos
Fotaki, Nikoletta and
Holm, Rene
Symillides, Mira
Reppas, Christos
Vertzoni, Maria
