Scientific Poster , Solubility Enhancement , Modified Release , Modelling & Simulation

AAPS 2021: Development and Application of a PBPK Model Using Theoretical Particle Size Distribution to Describe in vivo D issolution to Predict the Impact of Formulation Changes on Oral Bioavailability of GB001

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Overview

Download our AAPS 2021 poster entitled: 'Development and Application of a PBPK Model Using Theoretical Particle Size Distribution to Describe in vivo Dissolution to Predict the Impact of Formulation Changes on Oral Bioavailability of GB001'.

GB001 is a potent and highly selective prostaglandin D2 receptor (DP2/CRTH2) antagonist investigated for the treatment of moderate to severe asthma. GB001 is an L-lysine salt thus in vivo dissolution is unlikely to conform to standard Johnson model [1] behavior using measured particle size as an input. 

A theoretical particle size distribution (T PSD) linked Physiologically Based Pharmacokinetic (PBPK) model was developed to assess the impact of drug substance, formulation or manufacturing process changes on in vivo performance of GB001 immediate release (IR) tablets in humans.

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