ABSTRACT

Particle size distributions and surface areas of drug s u b s t a n c e s are properties of great importance both in bioavailability and in the processing of drug products. There should, therefore, be an effort to establish a running file of these properties as a function of lot of drug substance synthesized as development progresses. The preformulator is the first scientist to be able to assess this on the small samples he receives at the onset of the development project.