Testing the In-Vitro Product Performance of Nanomaterial-Based Drug Products: View of the USP Expert Panel
Matthias G. Wacker, Xujin Lu, Matt Burke, lshai Nir, Raafat Fahmy
Abstract
Today, a wide variety of nanomaterial-based drug products enter the US market, creating the need for reliable standards and technologies to measure their performance in-vitro. A growing number of new performance assays are evaluated for testing the drug release from nanomaterials. On the one hand, they include real time separation methods such as dialysis, fiber optical systems, and flow-separation techniques. On the other hand, sample-and-separate methods such as centrifugation, filtration, and solid-phase extraction are commonly used. In our evaluation of the existing practices, we provide guidance in method development and validation of release assays. Also, we discuss requirements for standardization and documentation of release data. Furthermore, we highlight the knowledge gaps and challenges associated with drug release testing of nanomaterial-based drug products.