Unit:
Τομέας ΦΑΡΜΑΚΕΥΤΙΚΗΣ ΤΕΧΝΟΛΟΓΙΑΣLibrary of the School of Science
Supervisors info:
Συμιλλίδου Μοίρα Αναπλ. Καθηγ.(Επιβλέπουσα), Ρέππας Χρήστος Καθηγ., Βαλσαμή Γεωργία Αναπλ. Καθηγ.
Original Title:
Βιομηχανική Φαρμακευτική
Summary:
The purpose of the study was to evaluate the stability of FaSSIF-V2plus (based
on sodium oleate and cholesterol concentration), under conditions simulating
the dissolution studies and equilibrium solubility measurements and to evaluate
the in vitro concentrations and potential precipitation of miconazole and
clopidogrel in the fasted upper small intestine, after administration of
solutions and immediate release solid formulations. The in vitro methodology of
Psachoulias et al. (2012) was used for solutions, while for solid formulations
the methodology was modified to take into account intragastric dissolution. A
three-compartment setup was used: a solution or a capsule/tablet was placed in
gastric compartment, a solution simulating the luminal environment
(FaSSIF-V2plus) was initially placed in duodenal compartment and concentrated
FaSSIF-V2plus was placed in reservoir compartment. FaSSIF-V2plus remains
unchained for at least 24 h and it can be used in normal equilibrium solubility
measurements using the shake-flask method. Concentrations in the upper small
intestine after administration of miconazole nitrate can be different from
these after administration of the free base. Significant precipitation occurs
in the duodenal compartment for all three salts of clopidogrel, under the first
30 min of gastric emptying. Finally, it is predicted that all three tablets
will continue to be bioequivalent after administration to hypohlorhydric
patients.
Keywords:
Miconazole, Clopidogrel, Precipitation, Supersaturation, Biorelevant media
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