Imaging Particle Analysis - Dry Powder Analysis for Pharmaceutical Formulations

 While designed for the analysis of particulates in fluids, the FlowCAM^® is also very useful for analysis of particulates that are "dry" in their native state. One merely needs to suspend the dry particles in any liquid that is inert to the particles under study. There are actually benefits to using this approach, in that the effects of static electricity on the particles is eliminated and any gravitational effects found in "dry analyzers" are also eliminated.

Many pharmaceutical products and ingredients, such as API's, fillers and excipients are commonly supplied and handled as dry powders. Particle size and shape of the particulates is critical to product performance in many different aspects of the manufacturing process. In particular, particle shape is critical to flowability in the manufacturing process, as well as adherence when tabletized and even taste.  It is also critical to be able to study rehydrated lyophilized products to determine longevity, storage effects, etc.

Sorbitol Sample #1 (click to enlarge)		Sorbitol Sample #2 (click to enlarge)

In the example shown above, two samples of Sorbitol, supplied as a dry powder, were analyzed in the FlowCAM to determine particle size and shape. It was suspected that the two sources being used were supplying different quality product, and imaging particle analysis was the method chosen to characterize the samples. Since Sorbitol is water-soluble, mineral oil was used to suspend the particles for analysis in the FlowCAM. The results clearly showed differences in the two samples.