Invitox - Can we cut the number of animal experiments?

By Rebecca Heys

We believe that many experiments using animals when designing formulations for drug toxicity studies could be replaced by in-vitro tests. In this project, Pfizer supplied data from completed toxicological studies. We re-created the formulations and ran biphasic dissolution experiments in simulated animal intestinal fluids to assess physicochemical characteristics and bioavailability. Scientists at the University of Bath analyzed our in-vitro data and found linear correlation between amounts detected in rat plasma and amounts dissolving in the biphasic lipid layer, thus demonstrating IVIVC.

Toxicity testing is an important part of drug development. Newly discovered molecules are tested, as well as metabolites and new formulations. The tests are generally done on rats, mice and dogs. Many of these tests are not actually done to test toxicity, but in preliminary studies to gather data used to design the final toxicity study. This preliminary data is used to design fit-for-purpose formulations, mainly for orally-administered drugs.

Tens of thousands of animals are sacrificed every year in the UK during drug toxicity testing; many more worldwide. If fit-for-purpose formulations can be assessed using in-vitro experiments, some 50% of animal experiments for testing drug toxicity could be eliminated.

We’ll show two posters about our recent research project at the AAPS annual meeting, November 2016:

A biphasic dissolution method to mimic oral absorption from simulated animal gastrointestinal fluids.

In vitro in vivo correlation of biphasic dissolution methods that mimic oral absorption from simulated rat gastrointestinal fluids.