Science & Research

Computational Model and Wireless Pharmaceutical Analysis Device to Measure in Vivo Drug Dissolution in GI Tract and To Distinguish Meaningful Product Quality Differences and Ensure Bioequivalence (BE) in Patients

Performer: College of Pharmacy, University of Michigan

Principal Investigator: Duxin Sun

Project Duration: 9/30/2015 – 9/29/2018

Regulatory Science Challenge

There are several types of oral generic and brand drugs that differ in the timing of drug release and dissolution (how well the drug dissolves in the gastrointestinal tract) in the human body - immediate release, modified release and locally acting. For these different types of oral drugs, it is unknown whether the current standards for measuring and comparing the equivalency of brand and generic products are sufficient. Also, it is unknown whether testing these drug products outside of humans (i.e., in laboratory cell culture models) is comparable to actual testing of their release and dissolution profiles in the human gastrointestinal tract. Improved methods for measuring the release and dissolution profiles of these drugs in the human gastrointestinal (GI) tract need to be identified to distinguish product differences and ensure bioequivalence of generic drug products to brand products. Development of a routine test to measure these drug properties in the GI tract in humans and improvement in the computational tools to analyze these data and predict drug dissolution activities would enable regulatory agencies and the pharmaceutical industry to use data from these tests to improve the drug development and approval process for these types of oral drug products.

Project Description & Goals

Researchers will design an ingestible wireless pharmaceutical analysis device to collect information and samples of fluids in the GI tract to be tested in a canine model. The samples and data from the device will be collected and analyzed to determine drug transit and dissolution throughout the GI tract. Similar studies will be performed in humans using a tube inserted into the GI tract, and GI fluids and plasma samples will be collected to determine and measure dissolution properties of oral drugs. These data will be used to develop a computational software tool kit that will improve laboratory models by predicting complete drug dissolution profiles in the human GI tract and levels of the drugs in plasma. The ultimate project goal is for the wireless device and validated software tool kits to be able to distinguish meaningful oral drug product differences, evaluate bioequivalence for these drugs, and improve the drug approval process.

Page Last Updated: 09/11/2017
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