In vivo-in vitro correlation for amoxicillin trihydrate 1000 mg dispersible tablet.
OBJECTIVE
An in vivo-in vitro correlation (IVIVC) for amoxicillin dispersible tablet was established.


METHODS
The model of absorption was constructed with type 2 dissolution apparatus and with the use of variable hydrodynamic conditions simulating passage through upper part of gastrointestinal tract. The in vivo test was performed on 24 volunteers.


RESULTS
The predicted errors for AUC and C(max) were calculated. Conditions of the in vitro test were discriminative to capsules, which were claimed to have lower bioavailability. The zero-order process of amoxicillin absorption enabled to establish the IVIVC more easily.


CONCLUSIONS
The described model showed features of level A correlation for immediate release dosage form and the zero-order process of amoxicillin absorption is an advantage for establishing IVIVC.
R&D Department, Polfa Tarchomin SA, Warszawa, Poland.
Michał
M
Ostrowski
Ewa
E
Wilkowska
Tomasz
T
Baczek
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D005260:Female; D006801:Humans; D008297:Male; D008954:Models, Biological; D012995:Solubility; D013607:Tablets; D055815:Young Adult
D000900:Anti-Bacterial Agents; D013607:Tablets; D000658:Amoxicillin