A miniaturized gut for optimization of oral medicines

The majority of pharmacologically active compounds suffers from solubility- or permeability-limited absorption and are in demand of advanced drug delivery systems (ADDSs) to enable absorption.

There is a lack of biorelevant in vitro models for studies of drug formulations and dosage forms, and the current approach is to explore a wide range of formulations in animal studies. Indeed, 60-80% of all animal studies performed in drug development is used during formulation screening.

In addition to the ethical challenge, the animal models do not necessarily have a gut similar to that of humans and results are often inconclusive. Our goal is to develop a 3D printed gut that can assess performance of ADDSs on the lab bench.

Specific objectives of the proposed project are: i)To establish a small-scale intestinal tube with fluid dynamics and motility pattern similar to that observed in humans.; ii) To replicate regional differences of the human small and large intestine in the miniaturized gut(mGUT) and thereby enable in vitro absorption studies from different regions.; and iii) To establish in vitro in vivo correlation between the mGUT and preclinical species as well as humans.

The mGUT will be validated with drug loaded ADDSs and oral medicines of different types.

When the objectives of this project are fulfilled, formulation development can revert from animal studies to in vitro assessments, contributing to both the reduce and replace principles of 3R.