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Article

Inhalable Protein Powder Prepared by Spray-Freeze-Drying Using Hydroxypropyl-β-Cyclodextrin as Excipient

1
Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong, China
2
Advanced Biomedical Instrumentation Centre, Hong Kong Science Park, Shatin, New Territories, Hong Kong, China
*
Author to whom correspondence should be addressed.
Academic Editors: Fabio Sonvico and Francesca Buttini
Pharmaceutics 2021, 13(5), 615; https://doi.org/10.3390/pharmaceutics13050615
Received: 27 March 2021 / Revised: 15 April 2021 / Accepted: 21 April 2021 / Published: 24 April 2021
(This article belongs to the Special Issue Advanced Characterization of Inhalation Medicinal Products)
The prospect of inhaled biologics has garnered particular interest given the benefits of the pulmonary route of administration. Pertinent considerations in producing inhalable dry powders containing biological medicines relate to aerosol performance and protein stability. Spray-freeze-drying (SFD) has emerged as an established method to generate microparticles that can potentially be deposited in the lungs. Here, the SFD conditions and formulation composition were evaluated using bovine serum albumin (BSA) as a model protein and 2-hydroxypropyl-beta-cyclodextrin (HPβCD) as the protein stabilizer. A factorial design analysis was performed to investigate the effects of BSA content, solute concentration of feed solution, and atomization gas flow rate on dispersibility (as an emitted fraction), respirability (as fine particle fraction), particle size, and level of protein aggregation. The atomization gas flow rate was identified as a significant factor in influencing the aerosol performance of the powder formulations and protein aggregation. Nonetheless, high atomization gas flow rate induced aggregation, highlighting the need to further optimize the formulation. Of note, all the formulations exhibited excellent dispersibility, while no fragmentation of BSA occurred, indicating the feasibility of SFD and the promise of HPβCD as an excipient. View Full-Text
Keywords: aerosolization; cyclodextrin; factorial design; inhalation; protein delivery; pulmonary delivery; spray-freeze-drying aerosolization; cyclodextrin; factorial design; inhalation; protein delivery; pulmonary delivery; spray-freeze-drying
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MDPI and ACS Style

Lo, J.C.K.; Pan, H.W.; Lam, J.K.W. Inhalable Protein Powder Prepared by Spray-Freeze-Drying Using Hydroxypropyl-β-Cyclodextrin as Excipient. Pharmaceutics 2021, 13, 615. https://doi.org/10.3390/pharmaceutics13050615

AMA Style

Lo JCK, Pan HW, Lam JKW. Inhalable Protein Powder Prepared by Spray-Freeze-Drying Using Hydroxypropyl-β-Cyclodextrin as Excipient. Pharmaceutics. 2021; 13(5):615. https://doi.org/10.3390/pharmaceutics13050615

Chicago/Turabian Style

Lo, Jason C.K.; Pan, Harry W.; Lam, Jenny K.W. 2021. "Inhalable Protein Powder Prepared by Spray-Freeze-Drying Using Hydroxypropyl-β-Cyclodextrin as Excipient" Pharmaceutics 13, no. 5: 615. https://doi.org/10.3390/pharmaceutics13050615

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