Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products

Gastro-retentive dosage forms are designed to have a prolonged residence time in the upper gastrointestinal tract to enhance bioavailability. However there has been no direct evidence of gastric retention in vivo. This project aims to gather direct evidence about the gastric retention of oral drug products which are claimed to be formulated as gastro-retentive dosage forms. This information may be helpful in supporting generic drug development and regulatory decision making. This opportunity solicits research proposals to use imaging technologies to monitor the gastric retention behavior of a reference product and its corresponding generic product, following oral administration. Various in vitro test methodologies should be explored to develop optimal method(s) that can be used by prospective generic applicants to support a demonstration of bioequivalence to the reference product, potentially for additional strengths of these generic products.