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Food effect risk assessment in preformulation stage using material sparing μFLUX methodology.

Corinne Jankovsky¹, Oksana Tsinman², Naveen K Thakral^1,3

¹Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, Connecticut 06877, United States.

|December 29, 2022

Summary

This summary is machine-generated.

Food intake significantly affects oral drug absorption. Evaluating drug diffusion across lipid membranes, alongside dissolution, offers a reliable early prediction of food effects on drug bioavailability.

Keywords:

Food effect bioavailability biorelevant medium clinical trial diffusion flux permeability predictive dissolution solubility

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Area of Science:

Pharmacokinetics
Drug Development
Biopharmaceutics

Background:

Food intake and meal composition critically influence oral drug bioavailability, impacting drug efficacy and safety.
Early drug development faces limited drug substance availability, making early prediction of food effects crucial.
While simulated intestinal fluid solubility offers initial insights, it doesn't always correlate with increased oral absorption.

Purpose of the Study:

To develop a reliable method for predicting the food effect on oral drug absorption during early drug development.
To assess the utility of combining drug dissolution and diffusion flux measurements for predicting food effects.
To provide early information for clinical trial design and dose adjustment strategies.

Main Methods:

Utilized 11 model compounds for study.
Measured drug dissolution in biorelevant media (fasted and fed state simulated intestinal fluid).
Evaluated drug diffusion flux across an artificial lipid-coated membrane, simulating unbound drug passage.

Main Results:

Drug dissolution in fed state simulated intestinal fluid did not consistently predict increased oral absorption.
Combining dissolution and diffusion flux measurements provided a reliable early prediction of food effects for most model compounds.
This combined approach offers valuable insights into drug absorption influenced by food intake.

Conclusions:

Diffusion flux across lipid membranes, in conjunction with dissolution, is a robust predictor of food effects in early drug development.
This method aids in anticipating drug bioavailability changes due to food, guiding clinical study design.
While limitations exist for drugs with significant intestinal metabolism or transporter involvement, the technique offers broad utility.