ABSTRACT

INTRODUCTION It is well established that the properties of granules, as well as the finished products, are significantly affected by certain properties of the raw materials employed. Characterization of drug substances and excipients is therefore an integral preformulation step. A good knowledge of different test methods is necessary to enable the selection of the most appropriate methods for the wide range of raw materials. The usefulness of the tests to give information on the properties of the raw materials and their effects on the manufacture, functionality, and esthetics of the granules and finished products should be carefully considered to avoid unnecessary testing and additional cost. This chapter aims to provide an overview of the more important properties of raw materials for granulation and the test methods that are available to evaluate these properties. Readers are strongly encouraged to refer to the appropriate references for in-depth discussion of the related scientific theories.