Predicting the pharmacokinetics and food effect of oral drug products using the ...

연구 요약

Predicting the pharmacokinetics and food effect of oral drug products using the dynamic gastrointestinal model (DGM).

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V 학술지에 발표된 이 연구는 Knopp MM, Jørgensen JR, Hansen LT 외 연구팀이 수행하였습니다.

이 연구는 'Predicting the pharmacokinetics and food effect of oral drug products using the dynamic gastrointestinal model (DGM).'에 대한 과학적 분석을 제공합니다.

핵심 내용

The pharmacokinetics (PK) of oral drug compounds are often significantly altered by food intake and evaluating this effect, as required by regulatory agencies, typically involves costly and time-consuming clinical trials. This study used the Dynamic Gastrointestinal Model (DGM), an advanced in vitro system simulating both biochemical and mechanical aspects of the human upper gastrointestinal tract, to predict plasma concentration-time profiles (PK profiles) and food effect of three immediate release oral drug products. The drug products, containing cinnarizine (CIN), diclofenac potassium (DIC) or paracetamol (PAR), were processed in the DGM mimicking the fasted and fed state clinical protocols and the resulting intestinal drug dissolution profiles were modelled (by convolution) to achieve the predicted PK profiles. The predicted PK profiles in both the fasted and fed state were in accordance with the observations in clinical trials, capturing both the positive food effect for CIN and the negative food effects for DIC and PAR. These findings demonstrate the ability of the DGM to provide insights into the PK performance and food effect of oral drug products.

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