ABSTRACT

A classification framework is required in which to discuss the form of a particle before manufacturing can begin. Once particles have been constructed, and assessed as geometric forms, their dimensions must be described in general terms. Particle size and distribution form the basis for such descriptors. Particle size and distribution are key properties from which many performance characteristics of a dosage form can be derived. The importance of particle properties in the action of drugs delivered from sophisticated targeted and controlled delivery systems has increased the rigor with which they are evaluated. Discussions of the benefits of crystal engineering are becoming more common, and the control of processes for the production of particles is of interest to regulatory and pharmacopeial groups. Integrating optimal sampling techniques and particle sizing methods with their process application by considering the nature of particle interactions in the context of the environment in which they exist forms the basis for good practice in pharmaceutical particulate science.