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Journal of Analytical Methods in Chemistry
Volume 2014 (2014), Article ID 810589, 8 pages
Research Article

Automated System for Kinetic Analysis of Particle Size Distributions for Pharmaceutically Relevant Systems

Baxter Healthcare, Technology Resources, 25212 W. Illinois Route 120, Round Lake, IL 60073, USA

Received 28 April 2014; Accepted 18 June 2014; Published 16 July 2014

Academic Editor: Sibel A. Ozkan

Copyright © 2014 John-Bruce D. Green et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Detailing the kinetics of particle formation for pharmaceutically relevant solutions is challenging, especially when considering the combination of formulations, containers, and timescales of clinical importance. This paper describes a method for using commercial software Automate with a stream-selector valve capable of sampling container solutions from within an environmental chamber. The tool was built to monitor changes in particle size distributions via instrumental particle counters but can be adapted to other solution-based sensors. The tool and methodology were demonstrated to be highly effective for measuring dynamic changes in emulsion globule distributions as a function of storage and mixing conditions important for parenteral nutrition. Higher levels of agitation induced the fastest growth of large globules (≥5 μm) while the gentler conditions actually showed a decrease in the number of these large globules. The same methodology recorded calcium phosphate precipitation kinetics as a function of [Ca2+] and pH. This automated system is readily adaptable to a wide range of pharmaceutically relevant systems where the particle size is expected to vary with time. This instrumentation can dramatically reduce the time and resources needed to probe complex formulation issues while providing new insights for monitoring the kinetics as a function of key variables.