Use of Wireless Capsule Endoscopy for Evaluation of Sustained Gastric Presence of a Polymer Medication Delivery System

Abstract

Purpose: Wireless capsule endoscopy (CE) has been demonstrated to be superior to traditional imaging for the diagnosis of small bowel disorders, but has not been utilized for investigation of gastric abnormalities. CE offers the potential opportunity to provide quantitative data regarding gastric emptying. The dosing and efficacy of drugs released via an extended release polymer delivery system is dependent on the retention of the device in the gastric lumen. The purpose of this study is to assess the utility of CE for the evaluation of the presence of a generic drug polymer delivery system in the stomach at specified time periods after ingestion. Methods: Eleven subjects taking daily metformin ER 500 mg (study tablet) were recruited to participate. Subjects ingested a standardized breakfast meal and the study tablet followed by an eight hour fasting period. Subjects underwent a CE study for a three hour period of time starting five hours after ingestion of the study tablet. Results: Ten subjects completed the study protocol. Photographs of the swollen study tablet after being immersed in simulated gastric fluid for several hours in a laboratory setting were used for comparison purposes. The images obtained from the remaining ten subjects showed the study tablet in the gastric lumen mixed with food debris. The study tablet could be identified on the basis of the tablet's smooth contour and uniform color. Conclusion: CE imaging was able to identify the study tablet in all 10 subjects despite the presence of retained food debris. CE offers the potential for the evaluation of gastric retention of drugs utilizing a polymer medication delivery system in a fed state.