May Webinar Presented by Dr. Xiaoming Xu from FDA/CDER/OPQ/OTR/DPQR
Connecting the Dots: Particle Size, Drug Distribution, and Drug Release in Nanoemulsions
Abstract: Measuring drug distribution and release from complex products that contain particulates, such as nanoemulsions, can be challenging but are considered critical tests of product quality. An ideal in vitro drug release test should be able to detect critical manufacturing process changes as well as variations in the product quality and performance. However, most of the currently available methods stop short of meeting the need. In this presentation, the inter-dependent relationships among several key physiochemical properties of nanoemulsions will be discussed. New methods that offer better understanding and control of drug distribution and drug release will also be presented.