Assessment of the feasibility of oral controlled release in an exploratory development setting.

Controlled release (CR) formulations have generally been considered as follow-ons to conventional immediate release formulations to manage the life cycle of a product. Although significant opportunities exist to use CR as an enabling technology for certain exploratory drug candidates, they have not been fully exploited. However, progress made in assessing CR feasibility based on the physicochemical and biopharmaceutical properties of the drug, together with advances made in understanding the various CR technologies and developing formulations in a fast and efficient manner, have increasingly made it possible to consider CR in an exploratory development setting.