In Vitro Performance Testing of Nanoparticulate Drug Products for Parenteral Administration

The parenteral administration route is most effective for the delivery of drug substances with poor oral bioavailability. Nanoparticulate drug delivery systems were developed with the specific purpose of overcoming the obstacles met by conventional drug therapy for parenteral administration in case of drug targeting or passing biobarriers. Today, in vitro performance tests are a prerequisite for formulation development and quality control of nanoparticulate dosage forms, focusing on drug release and stability of the release rate in particular if the release should extend to days. As a consequence of the diverse technologies of these novel dosage forms, at present there is no standardized in vitro release test available. With a focus on parenterally administered formulations, this review describes published methods used for in vitro drug release testing of nanoparticulate drug products. Some of the techniques may be applicable to nanoparticulate dosage forms for oral application.