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Digitalizing the TIM-1 Model using Computational Approaches-Part One: TIM-1 Data Explorer.

Inese Sarcevica¹, Bart Hens¹, Irena Tomaszewska¹

¹Drug Product Design, Pfizer, Discovery Park, Ramsgate Road, Sandwich CT13 9ND, U.K.

Molecular Pharmaceutics

|October 25, 2023

Summary

A new computational tool, TIM-1 Data Explorer, enhances biorelevant dissolution testing by analyzing mass balance in the TIM-1 gastrointestinal model. This tool enables quantitative predictions for drug product performance and PBPK modeling.

Keywords:

PBPK modeling digital model in silico modeling in vitro dissolution oral biopharmaceutics

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Area of Science:

Pharmacokinetics and Drug Metabolism
In Vitro Drug Testing Technologies

Background:

The TIM-1 gastrointestinal model simulates the human digestive system for biorelevant dissolution testing.
Current use of TIM-1 data is primarily qualitative, limiting quantitative pharmacokinetic predictions.
Physiologically based pharmacokinetic (PBPK) modeling requires more detailed input than standard bioaccessibility data.

Purpose of the Study:

To develop a computational tool, TIM-1 Data Explorer, for detailed analysis of fluid and mass balance in the TIM-1 system.
To expand the utility of TIM-1 model data beyond bioaccessibility for quantitative predictions.
To enable in-depth interpretation of TIM-1 experimental data, including drug dissolution and precipitation.

Main Methods:

Development of the TIM-1 Data Explorer computational tool.
Validation of the tool using two case studies involving paracetamol and a weakly basic compound (PF-07059013).
Analysis of mass balance, dissolution, and precipitation processes within the TIM-1 system.

Main Results:

The TIM-1 Data Explorer successfully describes fluid and mass balance within the TIM-1 system.
The tool accurately models mass transfer events, as demonstrated with paracetamol.
Dissolution and precipitation processes were effectively described for a weakly basic compound using the TIM-1 Data Explorer.

Conclusions:

The TIM-1 Data Explorer significantly enhances the quantitative application of TIM-1 gastrointestinal model data.
This tool facilitates more accurate PBPK modeling and supports improved drug product design.
The computational tool provides deeper insights into drug behavior within the simulated gastrointestinal environment.