2007 NSTI Nanotechnology Conference and Trade Show - Nanotech 2007 - 10th Annual

Sub Micron Particle Size and Shape Characterization by SEM

B.H. Lich*, L DesRosiers*, J Elands* and A.P. Tinke**
FEI Company, NL

Keywords:
particle, nanoscale, sub-micron, aggregation, characterization.

Abstract:
ABSTRACT In the pharmaceutical industry, SEM may be used as a qualitative tool for the analysis of drug substance and drug product in order to obtain information on the shape and surface structure of the material. These ana¬lytical capabilities can be essential to develop¬ing and maintaining manufacturing processes that meet industry GMP requirements. Flow, com¬paction and dissolution properties are essential process and material charac¬teristics in pharmaceutical production. All depend, to some extent, on struc¬ture and composition at the microme¬ter scale and below. SEM plays an important role in the characterization of nanoscale and sub-micron particles. Particle size, shape and aggregation are primary determinants of dissolution behavior and drug bioavailability. Also these parameters govern the flow characteristics within the pro¬duction process. As such they must be carefully controlled.

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