Journal of Aerosol Medicine and Pulmonary Drug Delivery最新文献

{"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":"<i>Letter:</i> Revisiting NAC's Multifaceted Role in Asthma Management: A Delicate Balance Between Anti-Inflammatory Potential and Airway Defense Attenuation.","authors":"Schawanya Kaewpitoon Rattanapitoon, Nav La, Natnapa Heebkaew Padchasuwan, Nathkapach Kaewpitoon Rattanapitoon","doi":"10.1177/19412711251391613","DOIUrl":"10.1177/19412711251391613","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"57-58"},"PeriodicalIF":1.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145668679","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":"Comparative Efficacy of Two Inhalational Techniques when Using a Pressurized Meter Dose Inhaler with Valved Holding Chamber in Children with Asthma: A Randomized Controlled Trial.","authors":"Rashmi Ranjan Das, Amit Kumar Satapathy, Manoj Kumar Panigrahi","doi":"10.1177/19412711251360981","DOIUrl":"10.1177/19412711251360981","url":null,"abstract":"<p><strong>Introduction: </strong>Inhaled medication delivered through a pressurized metered dose inhaler (pMDI) with a valved holding chamber (VHC) is the optimal treatment for asthma. The best technique is the breath-holding (BH) technique. Tidal breathing (TB) technique is also recommended by Global Initiative for Asthma (GINA) as an alternative. Clinical studies have shown variable results, but the scintigraphy study shows better lung deposition with the BH technique. The present study was designed to address the shortcomings in previous studies and to confirm the scintigraphy study findings by comparing the two techniques.</p><p><strong>Methods: </strong>This randomized controlled trial included children aged 5-14 years with nonsevere asthma not taking inhaled medications on entry to the study, but during the study, they were given inhaled medications by pMDI + VHC (according to GINA guidelines) over an 8-week period. Demography, clinical details, spirometry parameters, and asthma control were recorded/assessed. The primary outcome was change in spirometry parameters at 2 and 8 weeks.</p><p><strong>Results: </strong>Eighty-two children (mean age: 8.64 years, 46 boys) were included. There was no intergroup difference in the spirometry parameters and asthma control scores at any point in time (<i>p</i> > 0.05). A significant intragroup improvement was noted only for forced expiratory volume in the first second at 8 weeks (<i>p</i> < 0.05). Similarly, a significant intragroup improvement in asthma control score was noted at 8 weeks (<i>p</i> < 0.05). No adverse event was noted in either of the groups.</p><p><strong>Conclusions: </strong>The present study found no difference between the BH and the TB techniques while delivering aerosols through a pMDI with a VHC. Either the BH or the TB technique may be used in children (5-14 years) with nonsevere asthma.</p><p><strong>Clinical trial registration number: </strong>CTRI/2020/12/030078.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"22-27"},"PeriodicalIF":1.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636998","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":"Aerosol Therapy in the Emergency Department.","authors":"Alexander G Duarte, Rajiv Dhand","doi":"10.1089/jamp.2025.17897.agd","DOIUrl":"10.1089/jamp.2025.17897.agd","url":null,"abstract":"<p><p>Asthma and chronic obstructive pulmonary disease are prevalent conditions associated with sudden, symptomatic decline in respiratory function requiring urgent treatment. Management of acute airflow obstruction includes frequent, thorough assessments as well as timely administration of supplemental oxygen, corticosteroids and inhalational drug delivery of short acting bronchodilators. The benefits of inhaled administration of aerosolized short-acting bronchodilators include rapid symptom relief and improvements in lung function with fewer side effects. To optimize these benefits requires an understanding of the factors concerning aerosol delivery in the acute care setting that include patient age, severity of airway obstruction, aerosol generating device and the patient and device interface. Treatment strategies have been developed that include increased dosing of short-acting bronchodilators, combined administration of β-agonist and anticholinergic bronchodilators, continuous drug delivery and the use of helium to enhance lower respiratory tract drug deposition and improve patient outcomes.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"39 1","pages":"38-56"},"PeriodicalIF":2.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104943","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":"Development of Exclusive and Efficient Intranasal or Pulmonary Dosing Methods for a Dry Powder Tuberculosis Vaccine for Use in Nonhuman Primates.","authors":"John Z Chen, Scott Tavernini, Maximilian Aisenstat, Kelvin Duong, Hui Wang, Joseph McCollum, Wynton D McClary, Alana Gerhardt, Philip J Kuehl, Andrew R Martin, Reinhard Vehring, Christopher B Fox","doi":"10.1177/19412711251383716","DOIUrl":"10.1177/19412711251383716","url":null,"abstract":"<p><strong>Background: </strong>In spite of efforts to eradicate tuberculosis (TB), TB remains the deadliest infectious disease in the world; there is an urgent need for a thermostable, noninvasive TB vaccine suitable for distribution in the developing world. Spray-dried versions of a clinical-stage TB vaccine, ID93 + GLA-SE, are currently undergoing testing in baboons in both pulmonary and intranasal versions. We developed manufacturing processes and delivery systems to achieve delivery of each version to its intended site of action while avoiding off-target deposition.</p><p><strong>Methods: </strong>Pulmonary ID93 + GLA-SE was manufactured in a custom research-scale spray dryer. Delivery efficiency using a custom intratracheal insufflator was measured gravimetrically, and aerodynamic performance was evaluated via cascade impaction. Intranasal ID93 + GLA-SE was manufactured in a pilot-scale spray dryer. <i>In vitro</i> regional deposition in the Alberta Idealized Nasal Inlet, measured by LC-MS/MS, was used as a surrogate for aerodynamic performance; total deposition was used to calculate a total delivered dose. For both powders, ID93 antigen content was assessed using sodium dodecyl sulfate-polyacrylamide gel electrophoresis, and GLA-SE adjuvant content was assessed via HPLC.</p><p><strong>Results: </strong>No substantial processing losses of the antigen or adjuvant were observed after spray drying in either formulation. For the pulmonary powder, the emitted dose exiting the endotracheal tube across three tube sizes ranged from 15.9% to 21.4% of the nominal dose; for the 8 mm tube size, the emitted dose mass median aerodynamic diameter was 5.3 µm, which was deemed suitable for pulmonary administration. For the intranasal powder, the delivered dose was 88% ± 2% of nominal, and <i>in vitro</i> deposition in the posterior nasal cavity was 63% ± 10% of the emitted dose, with minimal anticipated lung deposition.</p><p><strong>Conclusions: </strong>Pulmonary and intranasal spray-dried ID93 + GLA-SE powders were successfully manufactured. The proposed dosing systems are expected to achieve exclusive pulmonary or intranasal delivery to nonhuman primates while requiring only a moderate amount of powder.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"11-21"},"PeriodicalIF":1.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199482","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":"Knowledge of Nurses and Primary Care Physicians on Inhaled Therapy Devices and Techniques.","authors":"Francisco Javier Plaza-Zamora, Valentín López-Carrasco, Jordi Giner-Donaire, Jaime Gonzalvez-Rey, María Del Carmen Mata-Hernández, Marta Villanueva Pérez","doi":"10.1177/19412711251380101","DOIUrl":"10.1177/19412711251380101","url":null,"abstract":"<p><strong>Background: </strong>We aimed to assess the knowledge of health care professionals regarding inhaled therapy devices and techniques and to evaluate the effectiveness of a targeted educational intervention.</p><p><strong>Methods: </strong>An educational program designed to update the knowledge and improve the technical skills of these professionals in the use of different types of inhalers was developed. Before and after each training session, we applied an <i>ad hoc</i> questionnaire that consisted of 15 multiple-choice questions on inhaled therapy grouped into three sections, including knowledge about devices used for inhaled therapy, knowledge about inhaler techniques, and knowledge about adherence to inhaled therapy, as well as the Test of the Adherence to Inhalers. The questionnaire also included a summary question. We calculated the mean score and the standard deviation for the pre- and postevaluations, compared the mean scores using Student's <i>t-test,</i> and evaluated the relevance of the changes using Cohen's <i>d</i>.</p><p><strong>Results: </strong>During the 23 meetings held throughout Spain, 267 participants completed the pretraining questionnaire, including 105 primary care physicians, 90 nurses of specialized care, 41 nurses working in primary care, and 31 health care professionals of various origins. Overall, the mean (SD) total score (i.e., number of correct answers out of a maximum of 15; range 0-15) significantly increased from 8.99 (2.26) to 11.46 (2.50) points, for a mean pre-post difference of 2.5 (<i>p</i> < 0.001). Notable issues included the misidentification of device types and confusion between inhalation techniques for pressurized metered-dose inhalers and dry powder inhalers. The mean total scores significantly increased across the three main specialties, with large effect sizes in all cases.</p><p><strong>Conclusion: </strong>Our study suggests that both primary care physicians and nurses have relevant gaps in knowledge- and technique-related issues regarding the use of inhalation devices that could be improved using a brief educational intervention.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"28-37"},"PeriodicalIF":1.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185081","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":"Clofazimine Inhalation Suspension: A Novel Formulation for the Treatment of Pulmonary Nontuberculous Mycobacterial Disease.","authors":"Wassim H Fares, Burkhard Blank, Michael Castagna, Thomas Hofmann","doi":"10.1177/19412711251370275","DOIUrl":"10.1177/19412711251370275","url":null,"abstract":"<p><strong>Background: </strong>Oral administration of clofazimine, an antimicrobial agent with demonstrated <i>in vitro</i> efficacy against nontuberculous mycobacteria (NTM), including <i>Mycobacterium avium</i> complex, requires high dosages to reach minimum inhibitory concentration in the lungs. Clofazimine Inhalation Suspension is a novel formulation designed to offer rapid, targeted drug delivery with prolonged half-life in lung tissues while minimizing systemic toxicities. The objective of this study was to evaluate the pharmacokinetic and safety profiles and proposed dosing regimen of Clofazimine Inhalation Suspension for adjuvant treatment of pulmonary NTM disease.</p><p><strong>Methods: </strong>A proposed dosing regimen consisting of 28 days of once-daily 4 mL Clofazimine Inhalation Suspension (nominal 80 mg clofazimine) via jet nebulizer followed by a 56-day drug-intake holiday was evaluated using: (1) a first-in-human phase 1 study examining safety, tolerability, and plasma pharmacokinetics of single and multiple ascending doses across 30-90 mg of clofazimine, (2) a physiology-based pharmacokinetic model establishing human equivalent dosing based on preclinical, and phase 1 human Clofazimine Inhalation Suspension data along with published oral clofazimine data and generated human lung pharmacokinetic estimates.</p><p><strong>Results: </strong>Human studies showed no safety issues at any dose. In healthy volunteers, treatment was well tolerated, with mild adverse events and no signs of systemic clofazimine deposition in the skin or sclera. Plasma drug levels are anticipated to remain below the previously established safe levels for oral clofazimine.</p><p><strong>Discussion: </strong>Clofazimine Inhalation Suspension demonstrated effective antimicrobial lung concentrations and achievable long-term coverage with potential for less systemic toxicity than oral clofazimine. This novel formulation is an alternative delivery strategy to oral ingestion for pulmonary NTM disease. Further evaluation in the phase 3 ICoN-1 global clinical trial is underway.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"1-10"},"PeriodicalIF":1.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175178","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":"Aerosol Delivery to an Adult Model via High-Flow Nasal Cannula with Inspiration-Synchronized Small-Particle Vibrating Mesh Nebulizer.","authors":"Jie Li, Osama Alanazi, James B Fink","doi":"10.1089/jamp.2025.0005","DOIUrl":"10.1089/jamp.2025.0005","url":null,"abstract":"<p><p><b><i>Background:</i></b> Aerosol delivery via high-flow nasal cannula (HFNC) with an inspiration-synchronized vibrating mesh nebulizer (VMN) yielded higher inhaled doses than with a continuous VMN. Recently, a prototype VMN generating aerosol particles <3 µm improved aerosol delivery during invasive ventilation in adult and pediatric models, outperforming the conventional VMN. However, the effects of inspiration-synchronized small-particle VMN during HFNC remain unknown. <b><i>Methods:</i></b> An adult manikin was connected to a dual-chamber lung model driven by a ventilator to simulate spontaneous breathing. An HFNC system was utilized with gas flows at 15, 30, and 60 L/min with temperature at 37°C. Both small-particle and conventional VMNs were tested in inspiration-synchronized and continuous modes, with placements at the humidifier inlet and near the nasal cannula. Each experiment involved delivering 1 mL of albuterol (2.5 mg/mL) and was repeated five times. A collecting filter placed at the trachea captured aerosol, which was then eluted and assayed with UV spectrophotometry (276 nm). <b><i>Results:</i></b> When VMN was placed near the nasal cannula, inspiration-synchronized VMN consistently delivered greater inhaled doses compared with continuous VMN, regardless of aerosol particle sizes or HFNC flows (all <i>p</i> < 0.05). When positioned at the humidifier inlet, continuous VMN yielded higher inhaled doses than inspiration-synchronized VMN at 30 and 60 L/min but lower inhaled doses at 15 L/min (all <i>p</i> < 0.05). In the inspiration-synchronized mode, the small-particle VMN delivered greater inhaled doses at HFNC flows of 15 and 30 L/min than the conventional VMN, independent of nebulizer placements (all <i>p</i> < 0.05). The highest inhaled dose was observed with the inspiration-synchronized VMN placed near the nasal cannula and the continuous VMN placed at the humidifier inlet. <b><i>Conclusions:</i></b> In a model of adult transnasal aerosol delivery, the inspiration-synchronized VMN delivered a higher inhaled dose than the continuous VMN when placed near the nasal cannula. The small-particle VMN offers potential for further improvement in aerosol delivery.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"394-399"},"PeriodicalIF":1.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560199","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":"<i>Corrigendum to:</i> \"<i>In Silico</i> Modeling of Resistances and Dosimetry in Sarcoidosis Patients with Airway Disease\".","authors":"","doi":"10.1177/19412711251368806","DOIUrl":"10.1177/19412711251368806","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"409"},"PeriodicalIF":1.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13090822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multi-Participant Blinded Investigation into Internal Losses of Medication in Commercially Available Mixing Inlets: Testing Different Orally Inhaled Product Classes Following Pharmacopeial Methods.","authors":"Patrik U Andersson, Jim Clay, Mark Parry, Teresa Iley, Daryl L Roberts, Lois Slator, Mårten Svensson, Hlack Mohammed, Jolyon P Mitchell","doi":"10.1177/19412711251370473","DOIUrl":"10.1177/19412711251370473","url":null,"abstract":"<p><p><b><i>Background:</i></b> The \"Miller\" design of mixing inlet (MI) enables a cascade impactor to operate at a constant flow rate while the orally inhaled product-on-test is evaluated at varying flow rates by controlling the flow of air via its side-arm. <b><i>Study Purpose:</i></b> As part of the European Pharmaceutical Aerosol Group (EPAG) Impactor subgroup, we report a cross-industry experimental investigation by five organizations to determine internal losses of different inhaler-generated aerosolized medications within commercially available MIs, focusing on pharmacopeial methods for product testing. <b><i>Methods:</i></b> Evaluations were undertaken of solution and suspension formulations delivered by pressurized metered dose inhalers (pMDIs), passive dry powder inhalers (DPIs), and compressed air-jet and vibrating mesh nebulizers. Four different apparatuses were evaluated at different constant air flow rates entering the MI side arm. The nebulizers were tested utilizing a variable adult flow profile generated by a breathing simulator. <b><i>Results:</i></b> Losses within the MI were generally <5%, expressed as a percentage of the delivered mass of active pharmaceutical ingredient (API) ex-inhaler. These losses were sufficiently small that they can in most cases be accommodated within the allowance of ±5% OIP label claim emitted mass/actuation in the pharmacopeial compendia for total internal losses for aerodynamic particle size distribution (APSD) determination. However, corresponding average losses were between 2.8% and 5.2% of the mass of API presented to the MI for the blister-based DPIs. APSD-derived measures were largely unaffected by the magnitude of pressurized air flow up to 60 L/min to the side-arm of the MI, except for the solution-formulated pMDI, where increasing flow rate was associated with reduced mass median aerodynamic diameter and increased geometric standard deviation, suggestive of a dependency related to ethanol co-solvent evaporation rate. <b><i>Conclusions:</i></b> MI loss evaluation should be considered an important part of method development to minimize internal losses of the aerosolized medication being sampled.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"373-385"},"PeriodicalIF":1.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955060","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}