In vivo-in vitro correlation for amoxicillin trihydrate 1000 mg dispersible tablet
Michał Ostrowski1, Ewa Wilkowska, Tomasz Baczek
1R&D Department, Polfa Tarchomin SA, Warszawa, Poland.
Objectives:
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.
Summary Of 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.
Overall 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.
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