Engineering Efficacious Controlled Release Therapeutics

Sunday, November 8, 2009
Ryman Hall B1/B2 (Gaylord Opryland Hotel)

Sam N. Rothstein, Department of Chemical Engineering, University of Pittsburgh, ChroKnow Solutions, Pittsburgh, PA
Steven R. Little, Chemical Engineering, University of Pittsburgh, Pittsburgh, PA

The engineering design methodology can streamline problems in fields as disparate as unit operations and immunotherapy. Specifically, the fundamental mathematics used to design, for example, a packed bed reactor also readily apply to a single injection vaccine and numerous other controlled release therapeutics. However, model-driven design is rarely used to develop medical treatments, like the latter. Changing this paradigm in both classroom and laboratory has been and will continue to be a focus of my career.

Most recently, I have combined in silico, in vitro, and in vivo methods to supplant the heuristic design of controlled release therapeutics with a rational, model-driven methodology. The backbone of this transformation is a newly developed predictive model connecting the fundamental design parameters to a formulation's drug delivery kinetics. Proof-in-principal for this design strategy comes from the development of two biodegradable microparticle formulations with dramatically different dosing kinetics and therapeutic payloads. Further, the efficacy of each formulation was confirmed with disease-specific, animal models. Together these data establish this mathematical approach as a platform for the design and development of controlled release therapeutics.

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