Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers.

The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in Caucasian healthy volunteers in fasting conditions.

The influence of averaging procedure on the accuracy of IVIVC predictions: immediate release dosage form case study.

In vivo-in vitro correlation (IVIVC) is an effective tool to predict absorption behavior of active substances from pharmaceutical dosage forms. The model for immediate release dosage form containing amoxicillin was used in the presented study to check if the calculation method of absorption profiles can influence final results achieved. The comparison showed that an averaging of individual absorption profiles performed by Wagner-Nelson (WN) conversion method can lead to lose the discrimination properties of the model.

In vivo-in vitro correlation for amoxicillin trihydrate 1000 mg dispersible tablet.

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.