Journal of Aerosol Medicine and Pulmonary Drug Delivery最新文献

{"title":"Identification of an Inhaled Pulmonary Selective PDGFR Inhibitor with Sustained Target Engagement.","authors":"Glenn Marsboom, Tianbao Lu, Zhigang Hong, Kimberly Holt, Makhosi Edmondson, Chin-Hu Huang, Amanda M Del Rosario, Salam Ibrahim, Victoria Wong, Michael Harbut, Steffen Jaensch, Zhijie Liu, Yifan Shi, Paul Shaffer, Pravien Abeywickrema, David Duda, Ji-Hoon Cho, Elsie Diaz, Weixue Wang, Harris Bell-Temin, Daniel Riley, Shefali Patel, Seonghee Park, Simon A Hinke, Andrea R Nawrocki, Lai-Ming Yung, Alexandra Schlicker Spain, Christopher John, Daniel Krosky, Shiyao Sherrie Xu, David R Bauman","doi":"10.1177/19412711261449635","DOIUrl":"https://doi.org/10.1177/19412711261449635","url":null,"abstract":"<p><strong>Background: </strong>Inhalation of corticosteroids, bronchodilators, antivirals, and antibiotics is well established to treat a variety of pulmonary diseases; however, no inhaled receptor tyrosine kinase (RTK) inhibitors have so far been approved for clinical use despite the key role of RTKs in several pulmonary diseases. We describe a detailed roadmap to identify, optimize, and derisk an inhaled platelet-derived growth factor receptor (PDGFR) inhibitor with extended activity in the lungs.</p><p><strong>Methods: </strong>In this study, stable isotopes were used to model receptor turnover <i>in vivo</i>, a high-resolution crystal structure was generated to support structure-based drug design and enhancement of both potency and specificity, and critical physicochemical parameters that drive lung retention were identified. Since some RTK inhibitors are linked to adverse interstitial lung disease in humans, we developed a cell painting assay that helped to eliminate compounds with non-specific effects.</p><p><strong>Results: </strong>We describe the steps we took to optimize the conditions for nebulized delivery to the deep lung and confirmed that >90% of PDGFR inhibition was maintained for at least 6 hours after nebulization of a 1 mg/kg dose in rats. Finally, modeling was used to calculate the projected human dose for this molecule.</p><p><strong>Conclusions: </strong>While the focus of this article is on the identification of an inhaled PDGFR inhibitor, our approach to develop a highly potent inhaled compound that has extended lung retention to minimize systemic effects could be adopted for other RTK drug discovery or lung targeting approaches.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261449635"},"PeriodicalIF":1.8,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Flow Control When Testing Dry-Powder Inhalers.","authors":"Daryl L Roberts","doi":"10.1177/19412711261448446","DOIUrl":"https://doi.org/10.1177/19412711261448446","url":null,"abstract":"<p><strong>Background: </strong>International compendia specify setting the flow for testing dry powder inhalers (DPIs) with the pressure ratio across the flow control valve ≤0.5. This guidance derives from thermodynamic theory, but there is no requirement that the flow control equipment demonstrates adherence to this theory. There is therefore a need to define and test for acceptable flow control valve performance, enabling DPI manufacturers to determine whether their test equipment is achieving the expected flow control. Herein, we present flow control data for two valves common in the inhaler testing community and describe the need for qualification specifications for flow control equipment with such valves.</p><p><strong>Methods: </strong>We devised a simple laboratory apparatus and method for determining the mass flow rate through two common flow control valves in their commercial configuration. In the test method, the pressure ratio across the valve is lowered from ∼0.7 to 0.3. This range of pressure ratio covers the standard test requirement that the pressure ratio must be 0.5 or less and maps the transition of compressible flow through the valve to the point where the air flow theoretically remains constant.</p><p><strong>Results: </strong>A common industrial valve, mentioned specifically in Pharm. Eur. 2.9.18 and in earlier editions of United States Pharmacopeia 601, exhibits nearly constant flow when the pressure ratio is <0.5. Another valve in widespread use exhibits a continued slight increase in mass flow rate even as the pressure ratio is decreased below 0.5.</p><p><strong>Conclusions: </strong>Inhaler testing laboratories should test whether their equipment exhibits the constant flow condition that is often assumed when the pressure ratio across the flow control valve is 0.5 or smaller. Quantitative specifications, yet to be developed, for qualifying commercial flow control equipment must account for both the transient start-up and the steady-state flow in DPI testing.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261448446"},"PeriodicalIF":1.8,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances in the Application of Additive Manufacturing in Respiratory Inhalation Therapy.","authors":"Chao Zhang, Xinyu Zhang, Junhui Zhang, Changhong Huo","doi":"10.1177/19412711261442505","DOIUrl":"https://doi.org/10.1177/19412711261442505","url":null,"abstract":"<p><p>Inhalation therapy has become a cornerstone in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease, and cystic fibrosis, owing to its rapid onset, direct pulmonary targeting, and avoidance of first-pass metabolism. Its clinical scope has expanded beyond conventional respiratory indications to emerging applications, including vaccine delivery, systemic disease management, and localized tumor therapy. However, traditional inhalation systems are often designed for the average patient, overlooking physiological variability that results in inconsistent drug deposition and therapeutic efficacy-particularly in children, elderly patients, and individuals with airway abnormalities. Additive manufacturing (AM), with its high design flexibility and capacity for personalization, offers new possibilities for structural optimization, particle engineering, and <i>in vitro</i> model fabrication in inhalation therapy. Growing evidence indicates that 3D-printed inhalation devices and formulation platforms can enhance drug deposition control, patient compliance, and delivery precision. This review provides a comprehensive overview of recent advances in AM applied to inhalation therapy, highlighting its roles in personalized device fabrication, microdose particle design, and <i>in vitro</i> model construction, as well as in the exploration of emerging therapeutic strategies. Furthermore, it discusses current technical challenges and translational barriers. Overall, AM is propelling the transition of inhalation therapy from standardized approaches toward intelligent, patient-centered delivery systems, offering both theoretical and technological foundations for next-generation respiratory healthcare.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261442505"},"PeriodicalIF":1.8,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal Maximal Forced Inspiratory Flow for Dry Powder Inhalers in Reducing Exacerbations in COPD.","authors":"Kwang Yong Choi, Heemoon Park, Hyo Jin Lee, Jung-Kyu Lee, Eun Young Heo, Deog Kyeom Kim, Hyun Woo Lee","doi":"10.1177/19412711251406054","DOIUrl":"10.1177/19412711251406054","url":null,"abstract":"<p><strong>Background: </strong>The optimal management of chronic obstructive pulmonary disease (COPD) requires effective drug delivery through dry powder inhalers (DPIs). Maximum forced inspiratory flow (FIFmax), easily obtained from routine spirometry, can reflect inspiratory capacity and serve as a physiological marker associated with exacerbation risk. However, its clinical implications have not been fully established.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed COPD patients treated with DPIs over a 5-year observational period. Baseline and follow-up FIFmax values were measured through repeated spirometric evaluations. The primary outcome was the incidence of moderate-to-severe exacerbations. The optimal cutoff of FIFmax for minimizing the risk of moderate-to-severe exacerbations was calculated, and the clinical factors associated with maintaining FIFmax above this optimal cutoff were explored.</p><p><strong>Results: </strong>A FIFmax threshold of 220 L/min was identified as the most optimal cutoff for lowering the risk of moderate-to-severe exacerbations. Patients who maintained FIFmax above this threshold over 5 years showed a significantly reduced risk of moderate-to-severe exacerbation (adjusted hazard ratio = 0.722 [95% confidence interval = 0.546-0.953], <i>p</i> = 0.022). Factors such as younger age, lower comorbidity burden, and better baseline lung function were linked to a higher FIFmax. In contrast, advanced age, severe comorbidities, and poor inhaler technique were associated with a rapid decline in FIFmax.</p><p><strong>Conclusion: </strong>FIFmax can be a promising physiological marker that reflects inspiratory capacity and stratifies exacerbation risk in COPD patients using DPIs. Regular assessment and patient education to maintain adequate inspiratory flow could support more effective disease management and stable long-term outcomes in this population.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"104-113"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145856367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploratory Pharmacokinetic Study of Pegylated Interferon Alfa-2b Aerosolized Inhalation Administration.","authors":"Hongran Chu, Hanzhou Wu, Fenfang Zou, Yalin Yin","doi":"10.1177/19412711251370951","DOIUrl":"10.1177/19412711251370951","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to compare the pharmacokinetics and tissue distribution of aerosolized pegylated interferon α-2b (PEG IFNα-2b) with standard interferon α-2b (IFNα-2b) in an animal model, paving the way for further investigation into their pharmacodynamics.</p><p><strong>Methods: </strong>Fifty-six Sprague Dawley rats were divided into 14 groups receiving either PEG IFNα-2b or standard IFNα-2b via aerosolized inhalation into the lower respiratory tract. Each group received a single dose of consistent concentration and volume. Pharmacokinetic parameters such as C_max, T_max, t_1/2, AUC_(0-t), and MRT_(0-t) were evaluated through blood samples and tissue dissection at specified time intervals post-administration.</p><p><strong>Results: </strong>Analysis revealed significantly higher AUC_(0-t) and MRT_(0-t) in the lungs, trachea, and bronchi of the PEG IFNα-2b group compared to the standard IFNα-2b group (<i>p</i> < 0.05), with minimal systemic exposure.</p><p><strong>Conclusion: </strong>Aerosolized PEG IFNα-2b demonstrated increased drug exposure and retention in the lower respiratory tract compared to standard IFNα-2b, suggesting potential therapeutic advantages such as reduced dosing frequency. Further studies are warranted to explore enhanced clinical outcomes.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"95-103"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of a Digital Inhalation Coach on Inhalation Errors and Asthma Control.","authors":"Laura J Arendsen, Kai M Beeh, Philipp Kroneberg, Michael Meyer, Sabine Häußermann, Marion Wencker","doi":"10.1177/19412711251370277","DOIUrl":"10.1177/19412711251370277","url":null,"abstract":"<p><strong>Background: </strong>Inhalation errors are a common source of underdosing in asthma therapy, leading to poor asthma control. Therefore, regular inhalation training is recommended. The Kata® app is a digital inhalation coach that provides step-by-step guidance on how to inhale effectively. This analysis evaluated the effect of the app on inhalation technique and clinical endpoints (fractional exhaled nitric oxide [FeNO]; Asthma Control Questionnaire [ACQ-5]) in a clinical trial.</p><p><strong>Methods: </strong>This <i>post hoc</i> analysis of app data collected during a phase-II randomized controlled trial, included adult patients with moderate-to-severe, uncontrolled type-2 high asthma (<i>N</i> = 78). A smartphone with the study-specific app version was provided and patients' usual asthma maintenance treatment entered. Inhalations were video recorded whenever the inhalation coach was used. Inhalation errors were scored by trained experts according to predefined criteria. Rates for total and critical errors (significantly affecting drug delivery) were calculated as the number of errors per inhalation. Analysis of clinical endpoints used data from the run-in phase only to avoid interference with study interventions.</p><p><strong>Results: </strong>Univariate regression analysis showed a significant decrease of the total error rate of 1.4% per study day (<i>p</i> < 0.001; 95% CI: 0.8-1.9) and of the critical error rate (1.8% per study day; <i>p</i> < 0.001; 95% CI: 1.0-2.6). A significant reduction of the ACQ-5 score was found for the run-in phase (<i>p</i> = 0.036; <i>N</i> = 59). The mean (SD) ACQ-5 change (V2-V0) was -0.2 (0.7), reflecting a small improvement of asthma control. A clinically relevant improvement of the ACQ-5 score was found in 18 of 59 patients (31%). No significant improvement of FeNO was found (<i>p</i> = 0.170; <i>N</i> = 60). However, 26 of 60 patients (43%) showed a clinically relevant decrease (>20%) of FeNO.</p><p><strong>Conclusions: </strong>The Kata app improved inhalation technique and this was accompanied by a small improvement of asthma control. The Kata app is a useful tool for patients using inhalers to treat their asthma.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"65-74"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145809991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical Studies of Clofazimine Inhalation Suspension: A Novel Formulation for the Treatment of Pulmonary Nontuberculous Mycobacterial Disease.","authors":"Wassim H Fares, Michael Castagna, Thomas Hofmann","doi":"10.1177/19412711251389444","DOIUrl":"10.1177/19412711251389444","url":null,"abstract":"<p><strong>Background: </strong>Clofazimine inhalation suspension is a novel formulation of clofazimine developed as a potential lung-targeted treatment for pulmonary nontuberculous mycobacteria disease.</p><p><strong>Methods: </strong>Safety and toxicokinetic parameters were assessed in 28-day, repeat-dose studies of up to 3.59 mg/kg/day clofazimine inhalation suspension in 8-week-old Sprague Dawley rats and up to 2.72 mg/kg/day in 5-7-month-old beagle dogs with 56-day recovery periods. A 6-month inhalation toxicity study without recovery was also conducted in beagle dogs, with daily doses up to 2.95 mg/kg for 182 days.</p><p><strong>Results: </strong>No adverse effects were observed, but minimal to mild nonadverse pulmonary changes were observed in high-dose treatment groups. The no-observed-adverse-effect levels were a sex-averaged 1.78 mg/kg in rats (28 days) and 2.73/2.95 mg/kg in male/female dogs (182 days). Median time to maximum concentration ranged from 6 to 12 hours and 0.5 to 6 hours in the rat and dog studies, respectively. Plasma area under the concentration-time curve from 0 to 24 hours and maximum plasma concentration increased dose-dependently and exhibited accumulation ratios ≥∼2 in both 28-day studies. Clofazimine concentrations in lung tissue were dose-dependent in all 3.</p><p><strong>Discussion: </strong>Clofazimine inhalation suspension was well tolerated at doses supporting multifold safety margins for the ongoing phase 3 ICoN-1 study. Lung concentrations exceeded the estimated minimum inhibitory concentration against <i>Mycobacterium avium</i> complex, even after 56 days of recovery.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"75-85"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145368012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Considerations for Medical Aerosol Products.","authors":"Svetlana Lyapustina","doi":"10.1177/19412711261420095","DOIUrl":"10.1177/19412711261420095","url":null,"abstract":"<p><p>This article provides a high-level overview of regulatory considerations for medicinal aerosol products around the world. It builds on our previous review and reflects developments related to more recent trends and innovations in science, business, technology, and regulation. All medicines, including medicinal aerosol products, must be approved by an appropriate government agency prior to marketing authorization. Knowing and complying with the requirements of an appropriate regulatory agency (or agencies) is a prerequisite to successful commercialization of any aerosol therapy. The range of governmental regulatory oversight is broad, including inspections of manufacturing sites, evaluations of preliminary data and study protocols before the start of trials in human subjects, evaluations of the sponsor's clinical and <i>in vitro</i> data for the proposed product, approval of final labeling and of postapproval changes to any aspect of the product or manufacturing process, monitoring of adverse event reports, and other areas. The specific regulatory requirements vary by the product type and by country, and they also change over time as the science and technology involved in the development, manufacture, and characterization of pharmaceutical and biological products evolve. In general, in order to obtain marketing authorization, the sponsor must demonstrate to regulators, using data from appropriately designed studies and other relevant documentation, (1) that the product is safe and efficacious for the proposed therapeutic indication in the target patient population, (2) that the product's manufacturing facility follows current good manufacturing practice^2-4 and/or quality management systems,^5,6 and (3) that appropriate quality control and quality assurance programs are in place, including programs to verify that the product released to the market, as well as product kept in stability-testing environmental chambers, complies with preset quality specifications. For aerosol delivery devices and drug-device or biological-device combination products, the sponsor must also assess the influence of human factors, device robustness, and materials' (bio)compatibility. The sponsor's responsibility to regulators continues after a product's approval in the form of, for example, required compliance with ongoing quality testing, pharmacovigilance monitoring, any postapproval commitments, and qualification of any postapproval changes. This article provides an overview of the regulatory considerations for inhaled and nasal products.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"114-128"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146119025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Difference in Exposure and Tolerability when Comparing Intratracheal Instillation with Inhaled Delivery.","authors":"Mikael Brülls, Elin Holmedal, Ramon Hendrickx","doi":"10.1177/19412711251374845","DOIUrl":"10.1177/19412711251374845","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the impact of two different routes of administration on the lung and systemic exposure of drugs designed for local delivery to the lung.</p><p><strong>Methods: </strong>In our comparative studies, similar lung doses of three different drugs were administered to rodents by both intratracheal instillation and inhaled delivery.</p><p><strong>Results: </strong>An obvious but unexpected difference in the exposure was observed. Immediately after the dose, the initial plasma concentration was much higher whereas the initial fraction of the lung dose in the lung was clearly lower for the instillation compared with the inhaled delivery. There was also a difference in the tolerability for one of the drugs when the same lung dose was administered and the inhaled dose was, in contrast to the instilled dose, tolerated by the mice.</p><p><strong>Conclusions: </strong>A plausible explanation for the observed but contrary to expected difference is that the drugs leaked from the lung into the systemic circulation already during the instillation procedure due to its invasive nature.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"86-94"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Image Segmentation Analysis Enables High-Throughput Next-Generation Impactor Analysis.","authors":"Jaston McClure, Daniel Dobson, Ed Yost, Derek M Dalton, Marcelino Varona","doi":"10.1177/19412711261436539","DOIUrl":"10.1177/19412711261436539","url":null,"abstract":"<p><strong>Purpose: </strong>Aerodynamic particle size distribution (APSD) determination is a key quality attribute for inhaled therapeutics. The next-generation impactor is the gold standard for APSD determination; however, it suffers from lengthy analysis times due to the need for high-performance liquid chromatography (HPLC)-based quantitation. In this work, a novel method employing image analysis is developed to derive APSD metrics from dry powder inhalers.</p><p><strong>Major findings: </strong>Analysis of neat active pharmaceutical ingredient (API), API/lactose blends, and stressed blend samples is demonstrated. The method shows sufficient resolution to differentiate between different sizes of neat API and within lactose blends. In addition, the results obtained from image analysis are comparable to the HPLC derived results.</p><p><strong>Conclusions: </strong>This study establishes the feasibility of image analysis for faster APSD determination.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261436539"},"PeriodicalIF":1.8,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}