Leveraging Synchrotron Tomography Analysis to Engineer Better Spray Dried Particles

Amorphous solid dispersions (ASDs) are a successful strategy to overcome challenges linked to molecules which present low solubility (BCS class II). Among the various manufacturing techniques available to prepare ASDs, spray-drying is well established, due to its simple scalability and suitability for thermolabile active pharmaceutical ingredients (APIs). Engineering of spray-dried particles with desired properties relies on an accurate particle characterization for size, shape, and surface area.

Next to the compendial methods, tomographic techniques have gained interest in the characterization of primary particles. Moreover, with the increased availability of Synchrotron facilities, SyncCT is being introduced in the pharmaceutical field, however, up to now, limited application on primary particles has been reported in literature.

The aim of the presentation is to show the capabilities of SyncCT to characterize primary particles, more specifically spray-dried particles, via a case study. Spray-dried particles were manufactured applying different processing conditions. The concepts were characterized for size by laser light diffraction and for specific surface area by BET. Results were then compared to those obtained via SyncCT image analysis.

A demonstration of the capabilities of SyncCT to segment and individually quantify particle classes will be presented, together with the ability of segmenting individual particles present in an agglomerate, which is one of the added values of this technique compared to the compendial methods. Moreover, the ability to quantify particle properties which cannot be measured with any other technique will be introduced, for example particle internal specific surface area can uniquely be quantified via imaging techniques.