Journal of Aerosol Medicine and Pulmonary Drug Delivery最新文献

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Evaluating Powder Deposition in the Nasal Airways Using a Facile Fluorescent-Imaging Method. 应用快速荧光成像方法评价鼻气道内粉末沉积。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-17 DOI: 10.1177/19412711261477975
William Hunter, Kiao Inthavong, Sara Vahaji, Svetlana Stevanovic, David Morton
{"title":"Evaluating Powder Deposition in the Nasal Airways Using a Facile Fluorescent-Imaging Method.","authors":"William Hunter, Kiao Inthavong, Sara Vahaji, Svetlana Stevanovic, David Morton","doi":"10.1177/19412711261477975","DOIUrl":"https://doi.org/10.1177/19412711261477975","url":null,"abstract":"<p><p><i>Background:</i> Intranasal drug delivery is a critical route for both systemic and targeted therapies, particularly for drugs intended to reach the central nervous system via the olfactory region. However, current aqueous nasal sprays have limited penetration beyond the anterior nasal airway, reducing their efficacy for nose-to-brain drug delivery. Nasal powder insufflators offer a promising alternative, as they allow higher drug payloads, typically up to 50 mg. The narrower spray cone angle of some powder insufflators has the potential for improved drug penetration, making them more suitable to deliver drugs higher and deeper into the nasal airways than is possible for aqueous nasal sprays. Despite this potential, existing methods for assessing powder deposition rely on complex and expensive imaging techniques such as gamma scintigraphy or MRI, limiting their accessibility for formulation and device optimization.<i>Methods:</i> This study presents a novel, cost-effective fluorescent imaging method to evaluate nasal powder deposition patterns using a transparent Koken nasal cast coated with synthetic mucus. Fluorescein-dyed spray-dried powders were delivered through a capsule-based nasal powder insufflator actuated by an air pulse, and deposition patterns were visualized under UV excitation. ImageJ analysis was used to quantify fluorescent intensity and distribution across five predefined nasal regions.<i>Results:</i> The results demonstrated that the powder delivery device successfully bypassed the anterior nasal airway and deposited a significant proportion of the dose in the olfactory region, achieving a mean posterior upper airway deposition of 51.7%, a substantial improvement over conventional aqueous sprays. The air pulse-actuated delivery mechanism also exhibited high repeatability, with a coefficient of variation of 14.9% in olfactory region deposition.<i>Conclusion:</i> By providing a simple, noninvasive alternative to radiolabeled imaging, this fluorescence-based approach enables rapid evaluation of nasal powder formulations and delivery devices. Hence, the approach described in this work could enable the nasal delivery device parameters, and powder formulation parameters to be optimized for nasal powder delivery devices. This could in turn allow drug delivery efficiency to different regions of the nose-particularly the upper nasal airways-to be optimized to suit different powder formulations, and different powder delivery devices.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261477975"},"PeriodicalIF":2.2,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148764957","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}
引用次数: 0
Preclinical Development of a Dry Powder Formulation of Loxapine for Intranasal Delivery. 用于鼻内给药的洛沙平干粉制剂的临床前开发。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-07 DOI: 10.1177/19412711261470959
Paul Shields, Irene Rossi, Daniela Schwotzer, Philip J Kuehl, Lucas Silva, Julie D Suman
{"title":"Preclinical Development of a Dry Powder Formulation of Loxapine for Intranasal Delivery.","authors":"Paul Shields, Irene Rossi, Daniela Schwotzer, Philip J Kuehl, Lucas Silva, Julie D Suman","doi":"10.1177/19412711261470959","DOIUrl":"https://doi.org/10.1177/19412711261470959","url":null,"abstract":"<p><strong>Background: </strong>Acute agitation (AA) is a common symptom of psychiatric conditions such as bipolar disorder and schizophrenia, resulting in 1.7 million emergency room visits per year in the United States. Loxapine, administered by inhalation, is an approved treatment for such scenarios. A boxed warning for bronchospasm when administered via inhalation limits its use to inpatient settings, making effective treatment for AA in outpatient settings an unmet need. The objective of this study was to develop and identify a lead intranasal dry powder formulation for outpatient treatment of AA.</p><p><strong>Materials and methods: </strong>Seven spray-dried nasal powders (Formulations A-G) consisting of loxapine succinate (Medichem, ES) and various excipients were manufactured and filled in a Unidose Nasal Powder system (Aptar Pharma, FR). In this pharmacokinetic study with non-compartmental analysis, formulations were evaluated both <i>in vitro</i> and <i>in vivo</i> (<i>n</i> = 4 non-human primates [NHPs]). Formulations were characterized by yield, assay, water content, particle size distribution, emitted dose, and impactor-sized mass.</p><p><strong>Results: </strong>Formulation B, comprising mannitol and hypromellose with 30% loxapine by weight, was identified as the lead candidate. In the <i>in vivo</i> portion of the study, all formulations were well tolerated. The plasma versus time profile for the NHP study indicated that Formulation B achieved the greatest extent of absorption (203.9 ng/mL*h) compared to the intravenous (control) formulation (231.5 ng/mL*h), each administered as a 3 mg dose. The full pharmacokinetic results for all formulations showed similar rapid absorption following dosing, although the area under the concentration-time curve and maximum concentration were lower than those observed with Formulation B. All formulations had similar apparent terminal half-lives.</p><p><strong>Conclusions: </strong>Formulation B showed clear advantages both <i>in vitro</i> and <i>in vivo</i>, supporting its suitability for further development as an outpatient treatment for AA in schizophrenia and bipolar disorder.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261470959"},"PeriodicalIF":2.2,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689320","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}
引用次数: 0
Letter: Letter to the Editor In Response to Weers et al. 信:致编辑的回应Weers等人的信。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-01 Epub Date: 2026-05-20 DOI: 10.1177/19412711261453165
Roy Pleasants
{"title":"<i>Letter:</i> Letter to the Editor In Response to Weers et al.","authors":"Roy Pleasants","doi":"10.1177/19412711261453165","DOIUrl":"10.1177/19412711261453165","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"207"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147972789","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}
引用次数: 0
Effect of Inspiratory Muscle Training on Aerosol Deposition and Pulmonary Perfusion in Post-COVID-19 Syndrome: A Gamma Scintigraphy Study. 吸气肌训练对covid -19综合征后气溶胶沉积和肺灌注的影响:伽玛闪烁成像研究
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-01 Epub Date: 2026-02-03 DOI: 10.1177/19412711261418482
Jose Carlos Nóbrega Júnior, Simone Soares Brandão, James B Fink, Daiara Xavier, Roberta Torres, Arzu Ari, Cyda Reinaux, Shirley Campos, Daniella Brandão, Armèle Dornelas de Andrade
{"title":"Effect of Inspiratory Muscle Training on Aerosol Deposition and Pulmonary Perfusion in Post-COVID-19 Syndrome: A Gamma Scintigraphy Study.","authors":"Jose Carlos Nóbrega Júnior, Simone Soares Brandão, James B Fink, Daiara Xavier, Roberta Torres, Arzu Ari, Cyda Reinaux, Shirley Campos, Daniella Brandão, Armèle Dornelas de Andrade","doi":"10.1177/19412711261418482","DOIUrl":"10.1177/19412711261418482","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary dysfunction in individuals with post-coronavirus disease-2019 (COVID-19) syndrome may impair aerosol deposition and pulmonary perfusion, compromising respiratory efficiency. Inspiratory muscle training (IMT) has been proposed as a strategy to improve respiratory mechanics and lung function.</p><p><strong>Objective: </strong>To compare aerosol deposition and pulmonary perfusion in individuals with post-COVID-19 syndrome before and after 8 weeks of IMT.</p><p><strong>Methods: </strong>This was a randomized controlled clinical trial involving 19 participants, divided into an IMT group (<i>n</i> = 10) and a control group (<i>n</i> = 9). The IMT group performed training with a load adjusted to 50% of maximal inspiratory pressure, while the control group used a device without resistance. Aerosol deposition and pulmonary perfusion were evaluated by gamma scintigraphy using the radioisotopes technetium-labeled diethylene-triamine-pentaacetic acid and technetium99-labeled macroaggregated human serum albumin, respectively. Total radiopharmaceutical activity in both lungs, as well as in the right and left lungs separately, was quantified pre- and post-intervention.</p><p><strong>Results: </strong>After 8 weeks, the IMT group showed a significant increase in total lung activity for both aerosol deposition (<i>p</i> = 0.028) and perfusion (<i>p</i> = 0.013). In the right lung, activity increased significantly for aerosol deposition (<i>p</i> = 0.005) and perfusion (<i>p</i> = 0.005). In the left lung, significant increases were also observed for perfusion (<i>p</i> = 0.007). No significant increases were observed in the control group. In the between-group analysis, the IMT group showed higher activity in both lungs combined and separately, compared with controls, for aerosol deposition (all <i>p</i> < 0.05) and in the right lung for perfusion (<i>p</i> = 0.010).</p><p><strong>Conclusion: </strong>IMT improved total aerosol deposition and perfusion in individuals with post-COVID-19 syndrome. These findings support the use of IMT as a rehabilitation strategy to enhance pulmonary deposition of inhaled agents and increase pulmonary perfusion in this population.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"198-206"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146112806","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}
引用次数: 0
Pharmacokinetic Analysis of Compounds Instilled into the Mouse Lung: Study with In Vivo Electron Spin Resonance Spectroscopy and Nitroxyl Spin Probes as Model Drugs. 小鼠肺内灌注化合物的药代动力学分析:体内电子自旋共振光谱和硝基自旋探针作为模型药物的研究。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-01 Epub Date: 2025-09-30 DOI: 10.1177/19412711251379678
Jin-Yi Han, Keizo Takeshita, Shoko Okazaki, Hideo Utsumi
{"title":"Pharmacokinetic Analysis of Compounds Instilled into the Mouse Lung: Study with <i>In Vivo</i> Electron Spin Resonance Spectroscopy and Nitroxyl Spin Probes as Model Drugs.","authors":"Jin-Yi Han, Keizo Takeshita, Shoko Okazaki, Hideo Utsumi","doi":"10.1177/19412711251379678","DOIUrl":"10.1177/19412711251379678","url":null,"abstract":"<p><strong>Introduction: </strong>Detailed understanding of the absorption mechanisms of compounds in the lungs is important for developing effective systems for the pulmonary administration of drugs. This study analyzed the pharmacokinetics of model compounds instilled into the mouse lungs using <i>in vivo</i> electron spin resonance (ESR) spectroscopy.</p><p><strong>Methods: </strong>An aqueous solution of a nitroxyl probe with cationic, anionic, or neutral groups was instilled into the lungs of healthy mice at high concentrations as model drugs, and the behavior of the probes was assessed using concentration-dependent changes in the linewidths of ESR signals obtained in live mice.</p><p><strong>Results: </strong>When solutions of nitroxyl probes at high concentrations, which produce broad ESR signals, were instilled into the mouse lungs, sharp ESR signals originating from diluted probes were superimposed onto broad signals. Broad signals decreased at various rates for all probes depending on their lipophilicity. Sharp signals for neutral probe and anionic probe immediately increased after instillation and then decreased. Sharp signals for cationic probe with a quaternary ammonium group continued to increase after instillation. Pharmacokinetic analysis of the blood concentrations of these probes suggests that the probes are distributed to lung tissues in addition to the blood. The concentration dependence of the initial velocity of broad signal decay suggests the possibility that the transfer of charged probes from the alveolar space to the bloodstream may be mediated by transporters, whereas a neutral probe may be transferred via passive diffusion.</p><p><strong>Conclusion: </strong>The differences in pharmacokinetic behavior in lungs could be examined <i>in vivo</i> among model compounds with different charge states. <i>In vivo</i> ESR spectroscopy is a powerful tool for the <i>in vivo</i> analysis of pulmonary pharmacokinetics, in combination with nitroxyl probes as model drugs.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"177-184"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199547","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}
引用次数: 0
Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases. 尼达尼布干粉吸入治疗肺纤维化疾病的安全性和药代动力学数据
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-08-01 Epub Date: 2026-01-13 DOI: 10.1177/19412711251414386
Wassim H Fares, Michael Castagna
{"title":"Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases.","authors":"Wassim H Fares, Michael Castagna","doi":"10.1177/19412711251414386","DOIUrl":"10.1177/19412711251414386","url":null,"abstract":"<p><strong>Background: </strong>Idiopathic pulmonary fibrosis (IPF) is an incurable disease marked by irreversible fibrosis and declining respiratory function. Nintedanib inhalation powder is a novel dry powder inhalation formulation of nintedanib consisting of Technosphere® particles that deliver active drug directly to the lungs, aiming to reduce systemic effects associated with oral treatment. The objective of the present work was to assess whether nintedanib dry powder inhalation (DPI) has the potential to provide improved safety and thus effectiveness compared with that of currently available therapeutic options for IPF.</p><p><strong>Methods: </strong>Three preclinical studies evaluated pharmacokinetic and toxicity outcomes associated with nintedanib inhalation powder. Two 28-day repeat-dose studies (one in rats and one in dogs), and a 6-month toxicity study in dogs assessed pulmonary and histological changes after inhaled nintedanib therapy. A phase 1, first-in-human, randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of nintedanib DPI versus placebo in healthy adults.</p><p><strong>Results: </strong>In the 28-day repeat-dose studies and the 6-month study, animals survived to scheduled necropsy without significant adverse findings, including no gastrointestinal adverse findings, and most achieved target pulmonary-deposited nintedanib concentrations. The phase 1 study demonstrated dose-proportional increases in nintedanib plasma concentrations after single doses and rapid absorption of nintedanib, with maximum concentrations within a few minutes of first dose at levels consistent with deep lung deposition. Nintedanib inhalation powder was considered safe and well tolerated throughout the study duration.</p><p><strong>Conclusion: </strong>Inhaled administration of nintedanib via DPI may offer advantages over oral therapies in patients with IPF, potentially reducing adverse effects associated with systemic exposure. Results of the preclinical and phase 1 studies support continued assessment of this formulation in patients with IPF and other pulmonary fibrotic diseases.</p><p><strong>Clinical trial registration number: </strong>NCT06532942.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"39 4","pages":"185-197"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148351898","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}
引用次数: 0
Letter: Impact of Suboptimal Peak Inspiratory Flow on Exacerbations in Chronic Obstructive Pulmonary Disease Patients Using Dry Powder Inhalers. 信:亚理想峰值吸入流量对使用干粉吸入器的慢性阻塞性肺疾病患者病情加重的影响。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-07-23 DOI: 10.1177/19412711261470936
Ji-Yong Moon, Sang Hyuk Kim, Youlim Kim, Hyun Lee, Chin Kook Rhee, Seung Won Ra, Chang Youl Lee, Joo Hun Park, Yong Bum Park, Kwang Ha Yoo
{"title":"<i>Letter:</i> Impact of Suboptimal Peak Inspiratory Flow on Exacerbations in Chronic Obstructive Pulmonary Disease Patients Using Dry Powder Inhalers.","authors":"Ji-Yong Moon, Sang Hyuk Kim, Youlim Kim, Hyun Lee, Chin Kook Rhee, Seung Won Ra, Chang Youl Lee, Joo Hun Park, Yong Bum Park, Kwang Ha Yoo","doi":"10.1177/19412711261470936","DOIUrl":"https://doi.org/10.1177/19412711261470936","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261470936"},"PeriodicalIF":2.2,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148562106","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}
引用次数: 0
Toward Next-Generation Propellants: Assessing Lung Deposition of Beclometasone Dipropionate, Formoterol, and Glycopyrrolate Formulated with HFA-152a Using Functional Respiratory Imaging. 迈向新一代推进剂:利用功能呼吸成像评估HFA-152a配制的二丙酸倍氯米松、福莫特罗和甘罗酸酯的肺沉积。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-07-16 DOI: 10.1177/19412711261464842
Angelo Matturro, Navid Monshi Tousi, Hosein Sadafi, Erika Cuoghi, Sara Panigone, Diego González-Segura, Gianluigi Poli, Federica Sandri
{"title":"Toward Next-Generation Propellants: Assessing Lung Deposition of Beclometasone Dipropionate, Formoterol, and Glycopyrrolate Formulated with HFA-152a Using Functional Respiratory Imaging.","authors":"Angelo Matturro, Navid Monshi Tousi, Hosein Sadafi, Erika Cuoghi, Sara Panigone, Diego González-Segura, Gianluigi Poli, Federica Sandri","doi":"10.1177/19412711261464842","DOIUrl":"https://doi.org/10.1177/19412711261464842","url":null,"abstract":"<p><strong>Background: </strong>Pressurized metered-dose inhalers (pMDIs) rely on hydrofluoroalkane (HFA) propellants that have a high global warming potential (GWP). Reformulation with next-generation, low-GWP propellants, such as HFA-152a, offers a strategy to reduce climate impact; however, changes in propellant composition can affect aerosol characteristics and potentially alter lung deposition, requiring robust demonstration of therapeutic equivalence.</p><p><strong>Methods: </strong>Functional respiratory imaging, combining high-resolution computed tomography and computational fluid dynamics, was used to compare the lung deposition of a fixed triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) delivered via a pMDI formulated with either HFA-134a (Reference) or HFA-152a (Test). Ten patients with chronic obstructive pulmonary disease (GOLD stages 2-4) were retrospectively selected. Patient-specific airway geometries, a standardized inhalation profile, and formulation-specific particle size distributions and plume characteristics were applied. Deposition was quantified in the intrathoracic, central + distal, and peripheral lung regions, and the (central + distal)/peripheral ([C + D]/P) deposition ratio was evaluated.</p><p><strong>Results: </strong>Mean intrathoracic deposition was comparable between the Reference and Test formulations, ranging from 45.95% to 46.88% of the delivered dose (DD). Deposition in the central + distal airways accounted for 12% of DD for both formulations, whereas peripheral deposition predominated, with 33.7% of DD for the Test formulation and 34.5% of DD for the Reference formulation. The (C + D)/P ratios were similar across all active components (0.35-0.37), indicating consistent preferential deposition in the peripheral/small airways. Although inter-patient variability was observed, intra-subject comparisons showed close agreement between propellants.</p><p><strong>Conclusion: </strong>Reformulation of the BDP/FF/GB pMDI with the low-GWP propellant HFA-152a preserved total and regional lung deposition characteristics relative to the current HFA-134a formulation. These findings support the maintenance of deposition performance while enabling a substantial reduction in environmental impact, reinforcing the potential of HFA-152a as a next-generation propellant for carbon minimal pMDI therapies.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261464842"},"PeriodicalIF":2.2,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148470820","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}
引用次数: 0
Mucociliary Clearance Following a Next-Generation Propellant Versus Hydrofluoroalkane-134a via Pressurized Metered-Dose Inhaler: A Randomized, Double-Blind, Two-Way Crossover Study in Healthy Adults. 新一代推进剂与氢氟烷烃-134a经加压计量吸入器后的粘膜纤毛清除:一项健康成人随机、双盲、双向交叉研究
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-07-16 DOI: 10.1177/19412711261470884
Scott H Donaldson, Kirby L Zeman, Alan Bell, Mandeep Jassal, Hitesh Pandya, Jennifer L Bell, Margareta Puu, Magnus Aurivillius, Mehul Patel, William Bennett
{"title":"Mucociliary Clearance Following a Next-Generation Propellant Versus Hydrofluoroalkane-134a via Pressurized Metered-Dose Inhaler: A Randomized, Double-Blind, Two-Way Crossover Study in Healthy Adults.","authors":"Scott H Donaldson, Kirby L Zeman, Alan Bell, Mandeep Jassal, Hitesh Pandya, Jennifer L Bell, Margareta Puu, Magnus Aurivillius, Mehul Patel, William Bennett","doi":"10.1177/19412711261470884","DOIUrl":"https://doi.org/10.1177/19412711261470884","url":null,"abstract":"<p><strong>Background: </strong>Pressurized metered-dose inhalers (pMDIs) are commonly used for respiratory disease treatment but contain propellants, such as hydrofluoroalkane-134a (HFA-134a), with global warming potential (GWP) that contribute to the climate emergency. To safeguard essential medicine access, it is crucial to transition to lower-GWP propellants, such as hydrofluoroolefin-1234ze (HFO-1234ze), which has 99% lower GWP than HFA-134a. In accordance with global regulatory requirements, this study was conducted to support the registration of pMDIs with HFO-1234ze.</p><p><strong>Methods: </strong>This randomized, double-blind, multicenter, two-way crossover study assessed the effects of HFO-1234ze versus HFA-134a on mucociliary clearance (MCC) in healthy participants aged 18-60 years. Participants received six inhalations twice daily of HFO-1234ze and HFA-134a in two 7-day (+3) intervention periods separated by a 7- to 14-day washout. The primary and secondary endpoints were change from period-specific baseline in average whole lung MCC (%) through 60 minutes (MCC60) and at 3 hours (MCC3h), respectively, measured via inhalation of <sup>99m</sup>Tc-labeled colloid and gamma camera imaging. Given significant baseline variability, a <i>post hoc</i> analysis of the primary endpoint assessed change from average baseline instead of period-specific baseline MCC60. Additional safety and tolerability measures were assessed.</p><p><strong>Results: </strong>Forty-five participants were screened; the Primary Analysis Set included 34 participants who completed both intervention periods. For the primary endpoint, change from period-specific baseline in MCC60 was negligible, with an estimated change (95% confidence interval [CI]) of -0.6% (-3.2%, 1.9%) for HFO-1234ze and 0.8% (-1.7%, 3.3%) for HFA-134a. The estimated least-squares mean difference (95% CI) between HFO-1234ze and HFA-134a was -1.4% (-5.8%, 2.9%). For the secondary endpoint, the estimated least-squares mean difference for change from period-specific baseline in MCC3h between HFO-1234ze and HFA-134a was -5.7% (-10.9%, -0.5%). There were no unexpected safety findings.</p><p><strong>Conclusion: </strong>There was no clinically relevant impact of HFO-1234ze versus HFA-134a on MCC in healthy participants.</p><p><strong>Clinical trial registration number: </strong>NCT05755932.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"19412711261470884"},"PeriodicalIF":2.2,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148470804","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}
引用次数: 0
Selecting the Optimal Inhaler in Asthma: Respiratory and Peripheral Muscle Strength as Predictors of DPI and MDI Response. 哮喘患者最佳吸入器的选择:呼吸和外周肌力作为DPI和MDI反应的预测因子。
IF 2.2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2026-06-29 DOI: 10.1177/19412711261464825
Buğra Kerget, Alperen Aksakal, Sırma Merve Çetin, Elif Yılmazel Uçar
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