Application of Size Exclusion Chromatography in the Development and Characterization of Nanoparticulate Drug Delivery Systems

Abstract The successful production of effective nanoparticulate drug delivery systems depends on maintaining the characteristics of the starting materials and the final formulation. Since compendial standards for traditional drug delivery systems do not always apply to nanosystems, analytical procedures for nanosized delivery systems must be established. This will ensure the quality of such products as they reach the marketplace. Size exclusion chromatography provides a method to continuously monitor all the development stages of nanoparticulate drug delivery systems, thereby, ensuring the quality of the starting materials used and the final product. The primary properties that can be monitored with this technique include particle size and molecular weight. Information about these properties not only serves as quality control measures, but can be used to monitor formulations for potential degradation products or impurities. Recent advances in size exclusion chromatography, such as the introduction of rapid analysis size exclusion columns and new chromatographs will make this technique even more applicable for nanosystem characterization. This implies that size exclusion chromatography might become an essential, economically feasible, and necessary analytical tool for ensuring the quality of nanoparticulate drug delivery systems.

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