Evaluation of food effect on the oral absorption of clarithromycin from immediate release tablet using physiological modelling

Radwan, Asma; Jayyousi, Rand; Shraim, Nasr Y.; Zaid, Abdel Naser

doi:10.1002/bdd.2176

Cited by 6 publications

(1 citation statement)

References 35 publications

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“…As shown in Table 3, solubility of BMS-820836 increases with decreasing of pH. However, solubility enhancement of BMS-820836 in biorelevant media is not determined which may explain why absorption of the compound is increased in the fed state as indicated by the simulation [17].…”

Section: Food Effectmentioning

confidence: 94%

Application of GastroPlusTM Modeling in Product Development: A Case Study for a Low-Dose Poorly Water-Soluble Compound

2022

GJPPS

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In this paper, GastroPlus™ modelling was applied to the development of a low-dose poorly water-soluble compound. The initial input parameters for simulation of solution were based on solubility, log D, permeability, and the dose together with dose volume of 250 ml. Typical physiology input parameters were used in simulation. Simulated curves were compared with clinical data for solution, and input parameters were optimized. Using the optimized input parameters from solution, simulated AUC curves of tablets of various strength (1mg, 3mg, and 5mg) were obtained and compared with solution AUC curves as well as clinical AUV curves, from which PK parameters were derived. Predictability of absorption of various dose was discussed for both tablet and solution. Furthermore, impact of dose, pH, and food effect on absorption was explored based on the simulated data. Overall, this case study demonstrated the use of GastroPlus™ in the drug development for a low-dose compound.

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Section: Food Effectmentioning

confidence: 94%

Application of GastroPlusTM Modeling in Product Development: A Case Study for a Low-Dose Poorly Water-Soluble Compound

2022

GJPPS

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Physiologically Based Pharmacokinetic (PBPK) Modeling Application on Food Effect Assessment

Gleeson

Kesisoglou

2023

AAPS Introductions in the Pharmaceutical Sciences

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Physiologically based pharmacokinetic modeling to assess the drug-drug interactions of anaprazole with clarithromycin and amoxicillin in patients undergoing eradication therapy of H. pylori infection

Liang

Zhou

et al. 2023

European Journal of Pharmaceutical Sciences

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Evaluation of food effect on the oral absorption of clarithromycin from immediate release tablet using physiological modelling

Abstract: Background: Food may affect the oral absorption of drugs. Purpose: The aim of the present study was to investigate the influence of food on the oral absorption of clarithromycin by evaluating the effect of media parameters, such as pH, bile secre-

Cited by 6 publications

References 35 publications

Application of GastroPlusTM Modeling in Product Development: A Case Study for a Low-Dose Poorly Water-Soluble Compound

Application of GastroPlusTM Modeling in Product Development: A Case Study for a Low-Dose Poorly Water-Soluble Compound

Physiologically Based Pharmacokinetic (PBPK) Modeling Application on Food Effect Assessment

Physiologically based pharmacokinetic modeling to assess the drug-drug interactions of anaprazole with clarithromycin and amoxicillin in patients undergoing eradication therapy of H. pylori infection

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