(255e) Move the Boundary and Raise the Bar

In the pharmaceutical industry, it has been a tradition to deal with the active ingredient (API) and the formulation (drug product, DP) separately.

As a consequence, large amounts of efforts have been devoted to designing in the desired properties of the API through particle engineering techniques.In addition, the linkage of API properties to the performance of the DP has been a holy grail for many of us in the industry. However, some of the desired properties of the API can be obtained by simply moving the boundary between API and DP. Some of the approaches that can improve density, material flow, solubility, stability and other properties will be reviewed. We hope to provoke some discussion of perceived obstacles to this approach.