ArticleInternational journal of pharmaceutics2024
Understanding the impact of mannitol on physical stability and aerosolization of spray-dried protein powders for inhalation.
Article in International journal of pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 23 citations in OpenAlex.
- Spray Dried Lysozyme Microspheres: Morphological Evolution and Enzymatic Activity Retention.Pharmaceutical research · 2026Article
- Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients.Journal of pharmaceutical sciences · 2026Article
- A novel spray-dried milk extracellular vesicles formulation with long-term immunomodulatory activity and functional stability.Scientific reports · 2026Article
- Pulmonary Drug Delivery for Infectious Diseases: Cutting-Edge Formulations and Manufacturing Technologies.Pharmaceutics · 2026Review
- Polymers as Stabilizing Excipients for Spray-Dried Protein Formulations.Pharmaceutical research · 2026Article
- From Pharmacological Uncertainty to Inhalation Development: An Evidence-Gated Roadmap forDrug design, development and therapy · 2026Review
- Recent Developments in Pharmaceutical Spray Drying: Modeling, Process Optimization, and Emerging Trends with Machine Learning.Pharmaceutics · 2025Review
- Spray drying: From a traditional technology to modern biotechnological applications.International journal of pharmaceutics: X · 2025Review
- Development of an inhalable dry powder of mycobacteriophage D29 using thin-film freeze-drying.International journal of pharmaceutics · 2025Article
- Breakthrough inActa biochimica et biophysica Sinica · 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
- 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
- Effects of buffers on spray-freeze-dried/lyophilized high concentration protein formulations.International journal of pharmaceutics · 2025Article
- Formulation of Bacteriophage for Inhalation to Treat Multidrug-Resistant Pulmonary Infections.Kona : powder science and technology in Japan · 2025Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
Abstract
Pulmonary delivery of protein-based therapeutics, including antibodies, is a promising option for treating respiratory diseases. Spray drying is a widely used method for producing dry powder formulations with mannitol being a commonly used excipient for these inhalation formulations. There is limited research available concerning the utilization of mannitol as an excipient in the spray drying of proteins and its impact on aerosol performance. This study highlights the importance to understand mannitol's potential role and impact in this context. To investigate the impact of mannitol on physical stability and aerosolization of spray-dried protein formulations, bovine serum albumin (BSA) was employed as a model protein and formulated with different concentrations of mannitol via spray drying. The spray-dried solids were characterized for their particle size using Malvern mastersizer and aerodynamic particle size using next generation impactor (NGI). Additionally, the solids were characterized with solid-state Fourier-transform infrared spectroscopy (ssFTIR), powder X-ray diffraction (PXRD), scanning electron microscopy (SEM) and solid-state nuclear magnetic resonance spectroscopy (ssNMR) to analyze the change in their secondary structure, crystallinity, particle morphology, and protein-excipient interaction, respectively. Size exclusion chromatography (SEC) was used to investigate changes in monomer content resulting from storage under stressed condition of 40 °C. Protein formulations containing more than 33 % mannitol by weight showed crystallization tendencies, causing an increase in monomer loss over time. ssNMR data also showed mixing heterogeneity of BSA and mannitol in the formulations with high mannitol contents. Futhermore, fine particle fraction (FPF) was found to decrease over time for the formulations containing BSA: Mannitol in the ratios of 2:1, 1:2, and 1:5, due to particle agglomeration induced by crystallization of mannitol. This study underscores the significant influence of excipients such as mannitol on the aerosol performance and storage stability of spray-dried protein formulations.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.