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Pharmaceutics
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Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery
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Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: 31 October 2026 | Viewed by 3279

Special Issue Editors

Dr. Sara E. Maloney

E-Mail Website
Guest Editor
Technology Advancement and Commercialization, RTI International, Research Triangle Park, Durham, NC 27709, USA
Interests: inhalation; spray drying; pulmonary drug delivery; aerosol drug delivery; nitric oxide; biopolymers; tuberculosis; nontuberculous mycobacteria
Dr. Francesca Buttini

E-Mail Website
Guest Editor
Department of Pharmacy, University of Parma, Viale delle Scienze 27/a, 43124 Parma, Italy
Interests: dry powder inhaler; particle engineering; inhalation therapy; high drug dose
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Aerosol therapy is a versatile approach for delivering drugs directly to the lungs of patients, offering a rapid onset of action, improving therapeutic efficacy, reducing off-target effects, and enhancing patient compliance. While particularly valuable for treating pulmonary diseases and infections, inhaled delivery can also be harnessed for systemic administration of therapeutics, including biologics and vaccines. However, whether intended for localized or systemic effects, optimizing aerosol therapy presents complex challenges, including the design of effective formulations, the advancement of inhalation devices, and the translation of laboratory findings into clinical practice.

This Special Issue of Pharmaceutics, ‘Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery’, aims to highlight innovative solutions and recent advances to address these challenges. We invite researchers to contribute original research articles, comprehensive reviews, and insightful perspectives on topics such as:

  • Novel formulation and particle engineering strategies for inhaled drugs, biologics, and vaccines;
  • Advances in inhalation devices and aerosol generation technologies;
  • Analytical tools, modeling, bioequivalence, and in vitro-in vivo correlations for aerosol performance;
  • Clinical, patient-centric, and regulatory considerations for inhaled therapies.

By bringing together leading experts across disciplines, this Special Issue seeks to advance our understanding of aerosol-based therapies and accelerate the development of next-generation pulmonary drug delivery systems. We warmly welcome your contributions and look forward to showcasing your latest findings and insights to help shape the future of pulmonary drug delivery.

Dr. Sara E. Maloney
Dr. Francesca Buttini
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • pulmonary drug delivery
  • aerosol therapy
  • inhalation drug delivery
  • particle engineering
  • inhaled biologics and vaccines
  • aerosol characterization
  • in vitro-in vivo correlation (IVIVC)
  • inhaler devices
  • lung deposition
  • clinical translation

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Published Papers (3 papers)

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Research

24 pages, 2699 KB  
Article
Optimization of Sugar-Derivatives Mixtures for Stabilizing Polyclonal Immunoglobulin G in Spray-Dried Inhalable Powders During Processing and Long-Term Storage
by Philippe Gevenois, Le Van Bui, Thami Sebti, Yvan Vander Heyden, Karim Amighi and Nathalie Wauthoz
Pharmaceutics 2026, 18(5), 573; https://doi.org/10.3390/pharmaceutics18050573 - 5 May 2026
Viewed by 1047
Abstract
Background/Objectives: The development of dry powder formulations for pulmonary delivery of therapeutic antibodies requires careful stabilization strategies to preserve protein integrity during spray-drying and long-term storage. This study investigates the impact of various sugar-derivatives, a polyol (D-mannitol), a disaccharide (D-sucrose) and a polysaccharide [...] Read more.
Background/Objectives: The development of dry powder formulations for pulmonary delivery of therapeutic antibodies requires careful stabilization strategies to preserve protein integrity during spray-drying and long-term storage. This study investigates the impact of various sugar-derivatives, a polyol (D-mannitol), a disaccharide (D-sucrose) and a polysaccharide (dextran 10 kDa), used individually or in combination, on the physical stability of bovine polyclonal immunoglobulin G (pAb) in dry powders for inhalation (DPIs). Methods: A design of experiments (DoE) approach was employed to evaluate the effects of these excipients on residual moisture (RM), low-order aggregates (LOA) and high-order aggregates (HOA), immediately after spray-drying (T0) and after 10 months of storage at room temperature in a desiccator (T10). Results: All DPIs exhibited a high amorphous content and a favorable glass transition temperature, with RM decreasing over time. The combination of D-mannitol and dextran 10 kDA (DPI-MD) demonstrated the most effective stabilization, minimizing LOA and HOA formation at T0 and T10. Although the ternary mixture, including D-sucrose (DPI-MSD) exhibited higher process stability, it was less stable over time in comparison to the binary mixture. The aerodynamic performance of these carrier-free DPIs, assessed via laser diffraction (% ˂ 5 µm), were between 51 ± 3 (DPI-MD) and 67 ± 4 (DPI MSD) and a Next Generation Impactor, confirmed that formulation produced aerosol with suitable size distribution and fine particle fractions (FPFn upt to 71 ± 5% for DPI-MSD), for deep pulmonary deposition. Conclusions: These findings highlight the importance of combining excipients with complementary physical properties to achieve robust protein stabilization. The DPI-MD emerged as the most promising candidate for pAb lung delivery, balancing protein integrity, powder stability, and aerodynamic efficiency. Full article
(This article belongs to the Special Issue Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery)
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21 pages, 1947 KB  
Article
A Distribution-Based Metric for Quantifying Dispersibility in Dry Powder Inhalers
by Grace Xia, Bhanuz Dechayont, Linze Che, Isabel Comfort and Ashlee D. Brunaugh
Pharmaceutics 2026, 18(3), 283; https://doi.org/10.3390/pharmaceutics18030283 - 24 Feb 2026
Viewed by 806
Abstract
Background/Objectives: Reproducible evaluation of aerosol dispersibility remains a key challenge in the development of dry powder inhalers (DPIs), where small variations in particle cohesion, morphology, or device resistance can lead to large differences in aerodynamic performance. In passive DPIs, the forces required for [...] Read more.
Background/Objectives: Reproducible evaluation of aerosol dispersibility remains a key challenge in the development of dry powder inhalers (DPIs), where small variations in particle cohesion, morphology, or device resistance can lead to large differences in aerodynamic performance. In passive DPIs, the forces required for powder fluidization and aerosolization arise from the interaction of patient inspiratory airflow with device geometry and must overcome strong interparticle cohesive forces to enable effective lung delivery. Cascade impaction is the gold standard for determining aerodynamic particle size distribution (APSD), but its low throughput and experimental burden limit its utility for systematic formulation and device screening. Prior studies have explored laser diffraction-based particle sizing under varying dispersion energies as indirect metrics of powder dispersibility. Here, we extend this approach by introducing a mathematically rigorous, distribution-based framework that applies the first-order Wasserstein distance (Earth Mover’s Distance) to quantify relative dispersibility with respect to a material-specific maximally dispersed reference state. Methods: Mannitol, trehalose, and inulin were spray-dried under matched conditions to generate model dry powders. Particle size distributions were measured by laser diffraction (Sympatec HELOS/R) using both a RODOS dry dispersion module to define a maximally dispersed reference state and an INHALER module to generate aerosols under clinically relevant dispersion conditions spanning multiple device resistances and pressure drops. For each condition, the Wasserstein-1 distance (W1) was computed between cumulative volume-based size distributions obtained under reference and inhaler-based dispersion. Cascade impaction was used as an orthogonal method to characterize aerodynamic performance under a representative dispersion condition. Results: W1 captured formulation-, device-, and flow-dependent differences in dispersibility that were not readily separable by visual inspection of particle size distributions alone. Crystalline mannitol exhibited the largest and most flow-rate-dependent W1 values, whereas amorphous trehalose and polymeric inulin showed smaller W1 values with distinct, non-monotonic pressure responses that depended on device resistance. W1 qualitatively aligned with cascade impaction metrics, exhibiting a positive association with mass median aerodynamic diameter and an inverse association with fine particle fraction, while also demonstrating that efficient dose emission can occur despite incomplete deagglomeration. Conclusions: This study establishes the Wasserstein distance as a physically interpretable, formulation-agnostic metric for quantifying aerosol dispersibility relative to a material-specific reference state. This framework enables systematic comparison of dispersion efficiency across devices and operating conditions using standard laser diffraction data and provides a reproducible basis for mechanistic optimization of DPI formulations and inhaler designs. Full article
(This article belongs to the Special Issue Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery)
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19 pages, 2802 KB  
Article
In Vitro and In Silico Evaluation of Polymyxin B Aerosol Delivery in Adult Mechanical Ventilation
by Shengnan Zhang, Guanlin Wang, Jingjing Liu, Xuejuan Zhang and Qi Pei
Pharmaceutics 2026, 18(1), 58; https://doi.org/10.3390/pharmaceutics18010058 - 31 Dec 2025
Cited by 1 | Viewed by 835
Abstract
Background: Nebulized polymyxin B (PMB) therapy is widely used in intensive care units for treating hospital-acquired and ventilator-associated pneumonia caused by multidrug-resistant Gram-negative bacteria, yet its pulmonary delivery performance during invasive mechanical ventilation remains poorly characterized. Methods: An in vitro adult mechanical ventilation [...] Read more.
Background: Nebulized polymyxin B (PMB) therapy is widely used in intensive care units for treating hospital-acquired and ventilator-associated pneumonia caused by multidrug-resistant Gram-negative bacteria, yet its pulmonary delivery performance during invasive mechanical ventilation remains poorly characterized. Methods: An in vitro adult mechanical ventilation model was used. We evaluated two nebulizers (vibrating mesh nebulizer [VMN] and jet nebulizer [JN]) at three positions (standalone nebulizer, 15 cm from the Y-piece, and the humidifier’s dry end) with two artificial airway types (endotracheal and tracheostomy tubes). Lung deposition was predicted using the multiple-path particle dosimetry model, incorporating the Yeh/Schum five-lobe adult lung model. Results: In the standalone setup, the percentage of delivered dose of VMN and JN was approximately 40% and 34%, respectively. Mechanical ventilation significantly reduced the delivered dose (all p ≤ 0.0085), with VMN at the humidifier’s dry end delivering only 2.14–2.99% of the nominal dose. In all the tested ventilation scenarios, both the use of the JN and positioning the nebulizer 15 cm from the Y-piece significantly increased aerosol delivery (all p ≤ 0.021). While the ventilator circuit reduced the total drug amount, it filtered larger aerosols. This resulted in a smaller mass median aerodynamic diameter and a higher fine particle fraction (all p < 0.0001), which doubled the predicted alveolar deposition fraction (from 13–14% in standalone to 23–28% in ventilation scenarios) and eliminated extrathoracic deposition. Conclusions: This study provides the first in vitro and in silico assessment of PMB aerosol delivery during invasive mechanical ventilation. Nebulizer type, its placement within the circuit, and the artificial airway are critical factors that significantly alter the pulmonary delivery of PMB aerosol and subsequently impact its lung deposition. Full article
(This article belongs to the Special Issue Optimizing Aerosol Therapy: Strategies for Pulmonary Drug Delivery)
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