IN VITRO METHODOLOGY FOR PREDICTING IN VIVO ABSORPTION OF BIOABSORBABLE POLYMERIC IMPLANTS AND DEVICES

摘要

A novel in vitro methodology for predicting the in vivo behavior, such as absorption time or mechanical strength retention, of biodegradable polymeric implants and medical devices. The present invention provides a novel in vitro methodology, hydrolysis profiling, for studying the degradation of absorbable polymers. Accuracy and reproducibility have been established for selected test conditions. Data from this in vitro method are correlated to in vivo absorption data, allowing for the prediction of accurate in vivo behaviors, such as absorption times.