Abstract

In recent years, significant advances have been made in drug delivery systems through the use of both natural and synthetic polymers. Polymers (with desired physicochemical properties) can be used in the manufacture of tablets, implants, microspheres, nanoparticles, drug-eluting stents, in situ forming gels, and polymeric scaffolds (for tissue engineering) to achieve the goal of controlled drug ­delivery. Various in vitro and in vivo methods are available to evaluate both the polymer excipients and the final formulations to achieve an ­understanding of in vivo performance. This chapter provides an overview of characterization methodologies for polymeric drug delivery systems, including mechanical properties, surface and morphological analysis, and in vitro/in vivo biocompatibility testing and in vitro drug release testing. Current regulatory guidelines for biocompatibility testing of biomedical devices and in vitro dissolution testing of polymeric formulations are also discussed.

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