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Updated: Dec 30, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Critical steps during the prilling process of molten lipids: Main stumbling blocks due to pharmaceutical excipient
F Séquier1, V Faivre2, J-Y Lanne3
1Université Paris-Saclay, CNRS, Institut Galien Paris Sud, 5 rue JB Clément, 92296 Châtenay-Malabry, France; Sanofi Winthrop Industrie, 1 Rue de la Vierge, 33 565 Carbon Blanc Cedex, France.
Abstract:
Prilling by ultrasonic jet break-up is an efficient process to produce perfectly spherical microparticles homogeneous in size. However, the material properties could affect the manufacturability and the final product properties especially with lipid-based excipients which often exhibit complex structural properties. This work presents the characterisation of six lipid-based excipients differing by their melting point and polymorphic behaviour which were used to produce microspheres using a pilot-scale prilling equipment. The experimental results were compared to theoretical calculations, especially the droplet solidification time which is a key-parameter for this process. This work highlighted that monotropic polymorphism of excipients and supercooling effect have a significant impact on process parameters which should be considered with care during formulation design.
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