ABSTRACT
Modified release of a drug from its delivery system is a conscious dosage form development effort. To support such an endeavor, a framework for various material or process options and key performance considerations for the development of a robust granulated modified-release product are presented first and exemplified by five case studies later in this chapter. The studies illustrate select options from different formulations and granulation processes (foam/extrusion/dry/spray/multiparticulate) for modified release of active pharmaceutical ingredient(s), and their resultant drug release outcomes are discussed.
