Applications of particle size analysis in the pharmaceutical industry

Abstract

Recent innovations in equipment for particle size analysis have enabled complete particle size distributions of fine powders to be obtained both cheaply and rapidly. This development has enabled applications, which previously would have been of only academic interest, to be developed as practical methods for routine use in the pharmaceutical industry. Four applications of particle size analysis based on a Model T_A Coulter counter are described: (1) the detection of fluctuations in the process variables of a batch crystallisation process; (2) close control of pharmaceutical grinding; (3) evaluation of the particle size distribution of the disintegration products of tablets; and (4) the assay of the percentage of amorphous insulin in Insulin Zinc Suspension.