ArticleMolecular pharmaceutics2021
Understanding the Impact of Protein-Excipient Interactions on Physical Stability of Spray-Dried Protein Solids.
Article in Molecular pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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Who cites it
28 citing papers in PubMed, 64 citations in OpenAlex.
- Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles.AAPS PharmSciTech · 2026Article
- Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients.Journal of pharmaceutical sciences · 2026Article
- Spray Dried Lysozyme Microspheres: Morphological Evolution and Enzymatic Activity Retention.Pharmaceutical research · 2026Article
- The Impact of Particle Properties on High Concentration Suspension Performance and Stability of Spray-Dried Monoclonal Antibodies.Pharmaceutical research · 2026Article
- Polymers as Stabilizing Excipients for Spray-Dried Protein Formulations.Pharmaceutical research · 2026Article
- Stabilising large biologics through complimentary buffer component protection and rapid drying times.International journal of pharmaceutics: X · 2025Article
- Spray drying: From a traditional technology to modern biotechnological applications.International journal of pharmaceutics: X · 2025Review
- Leucine Protects Dry Powders for Inhalation Against Irreversible Moisture-Induced Aggregation.Pharmaceutics · 2025Article
- Understanding the impact of L-leucine on physical stability and aerosolization of spray-dried protein powder formulations containing trehalose.International journal of pharmaceutics · 2025Article
- Powder aerosol formulation of Pseudomonas aeruginosa bacteriophage for pulmonary delivery.International journal of pharmaceutics · 2025Article
- Particle surface coating for dry powder inhaler formulations.Expert opinion on drug delivery · 2025Review
- Investigating the Interaction between Excipients and Monoclonal Antibodies PGT121 and N49P9.6-FR-LS: A Comprehensive Analysis.Molecular pharmaceutics · 2025Article
- Dry powder formulations of hyperimmune serum.Drug delivery and translational research · 2025Article
- Comprehensive Aerodynamic and Physicochemical Stability Evaluations of Nanocrystal-Based Dry Powder Inhalers: The Role of Mannitol and Leucine in Enhancing Performance.Pharmaceutics · 2025Article
- Navigating the Development of Dry Powder for Inhalation: A CDMO Perspective.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Understanding dry proteins and their protection with solid-state hydrogen-deuterium exchange.Protein science : a publication of the Protein Society · 2025Review
- Protein and Peptide Therapeutics: Stability Challenges, Regulatory Demands, and Innovative Formulation Solutions for Enhanced Clinical Effectiveness.Protein and peptide letters · 2025Review
- Formulation of Bacteriophage for Inhalation to Treat Multidrug-Resistant Pulmonary Infections.Kona : powder science and technology in Japan · 2025Article
- Camel milk whey powder formulated using thermal (spray-drying process) and non-thermal (ultrasonication) processing methods: Effect on physicochemical, technological, and functional properties.Ultrasonics sonochemistry · 2024Article
- Investigation of the Solid-State Interactions in Lyophilized Human G-CSF Using Hydrogen-Deuterium Exchange Mass Spectrometry.Molecular pharmaceutics · 2024Article
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
Abstract
Mannitol, leucine, and trehalose have been widely used in spray-dried formulations, especially for inhalation formulations. The individual contribution of these excipients on protein physical stability in spray-dried solids was studied here using bovine serum albumin (BSA) as a model protein. The spray-dried solids were characterized with scanning electron microscopy, powder X-ray diffraction, and solid-state Fourier-transform infrared spectroscopy to analyze particle morphology, crystallinity, and secondary structure change, respectively. Advanced solid-state characterizations were conducted with solid-state hydrogen-deuterium exchange (ssHDX) and solid-state nuclear magnetic resonance (ssNMR) to explore protein conformation and molecular interactions in the context of the system physical stability. Trehalose remained amorphous after spray-drying and was miscible with BSA, forming hydrogen bonds to maintain protein conformation, whereby this system showed the least monomer loss in the stability study. As indicated by ssNMR, both crystalline and amorphous forms of mannitol existed in the spray-dried BSA-mannitol solids, which explained its partial stabilizing effect on BSA. Leucine showed the strongest crystallization tendency after spray-drying and did not provide a stabilizing effect due to substantial immiscibility and phase separation with BSA as a result of crystal formation. This work showed novel applications of ssNMR in examining protein conformation and protein-excipient interaction in dry formulations. Overall, our results demonstrate the pivotal role of advanced solid-state characterization techniques in understanding the physical stability of spray-dried protein solids.
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Registered trials
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