Effect of pH and Excipients on Structure, Dynamics, and Long-Term Stability of a Model IgG1 Monoclonal Antibody upon Freeze-Drying

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Spray-drying and freeze-drying are effective approaches to improve the long-term stability of nanosuspensions. This research explored the effect of spray-drying and freeze-drying techniques on PVP K30-stabilized silybin nanosuspensions. The morphology was observed by scanning electron microscopy (SEM): The spray-dried sample was spherical, and the freeze-dried samples were rodlike with smooth surfaces. The redispersibility was studied via dynamic light scattering (DLS): The size, PDI, and zeta of the spray-dried sample were 133.27 nm, 0.214, and 24.37 mV, respectively; the size, PDI, and zeta of the freeze-dried sample were 298.70 nm, 0.114, and 20.98 mV, respectively. The in vitro dissolution was studied, and the two dry powders showed a significant increase compared to silybin. The two dried powders had better long-term stability than the liquid starting material. Overall, spray-drying and freeze-drying are appropriate drying methods for the preparation of silybin nanosuspensions with better stability and dissolution velocity.


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Ana Cristina Calpena Campmany ◽  
María Antonia Egea Gras ◽  
Marta Espina García ◽  
María Luisa García López

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