Proteins and peptides delivered via the oral route can be subject to degradation when exposed to the gastric environment. Through the application of polymeric based coatings, targeted hard capsule rupture can be used to protect gastro- sensitive API’s1. Prior to clinical trial, early pharmacokinetic (PK) studies are often conducted in small animals, such as the mouse or rat. The pH variation within the rat and mouse GI system is not comparable to that of a human2, therefore a suitable enteric coating is required to target appropriate release in the selected animal model.
The purpose of this study was to investigate the in-vivo performance of an anti-inflammatory monoclonal antibody, administered to the mouse model, via the oral route, using an enteric coated hard capsule. The performance of the enteric coated capsule was compared to liquid administration.