Critical steps during prilling process of molten lipids: main stumbling blocks due to pharmaceutical excipient properties.

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2020
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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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squier2020criticalinternational Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Séquier, F;Faivre, V;Lanne, J-Y;Daste, G;Renouard, M;Lesieur, S;
Journal International journal of pharmaceutics
Year 2020
DOI
S0378-5173(20)30018-1
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