A retrospective mathematical analysis of controlled release design and experimentation.

The development and performance evaluation of new biodegradable polymer controlled release formulations relies on successful interpretation and evaluation of in vitro release data. However, depending upon the extent of empirical characterization, release data may be open to more than one qualitative interpretation. In this work, a predictive model for release from degradable polymer matrices was applied to a number of published release data in order to extend the characterization of release behavior. Where possible, the model was also used to interpolate and extrapolate upon collected released data to clarify the overall duration of release and also kinetics of release between widely spaced data points. In each case examined, mathematical predictions of release coincide well with experimental results, offering a more definitive description of each formulation's performance than was previously available. This information may prove particularly helpful in the design of future studies, such as when calculating proper dosing levels or determining experimental end points in order to more comprehensively evaluate a controlled release system's performance.