Abstract
Evaluation of orally ingestible devices is critical to optimize their performance early in development. Using animals as a pre-clinical tool can provide useful information on functionality, yet it is important to recognize that animal gastrointestinal physiology, pathophysiology and anatomy can differ to that in humans and that the most suitable species needs to be selected to inform the evaluation. There has been a move towards in vitro and in silico models rather than animal models in line with the 3Rs (Replacement, Reduction and Refinement) as well as the better control and reproducibility associated with these systems. However, there are still instances where animal models provide the greatest understanding. This paper provides an overview of key aspects of human gastrointestinal anatomy and physiology and compares parameters to those reported in animal species. The value of each species can be determined based upon the parameter of interest from the ingested device when considering the use of pre-clinical animal testing.
Highlights
Animals are used as pre-clinical models to evaluate the therapeutic index, toxicity and linear/non-linear pharmacokinetics of a drug, guiding human dose and formulation development
Key factors to consider in the applicability of animal models in the evaluation of ingestible devices for screening and diagnosis include the anatomical shape of the organ, the motility and the transit time
The stomach is the first region within the GI tract where the ingested device will reside for a period of time
Summary
The stomach is the first region within the GI tract where the ingested device will reside for a period of time. An understanding of the gastric environment is important to consider how the fluid volume; composition; motility and transit may affect the device under test
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