Journal of Aerosol Medicine and Pulmonary Drug Delivery最新文献

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Hypertonic Aerosols Hydrate Airways Longer and Reduce Acidification Risk with Nonpermeating Cation and Permeating Anion Salts. 非渗透性阳离子盐和渗透性阴离子盐的高渗气溶胶可使呼吸道长时间保持水合状态并降低酸化风险。
IF 2 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-04-01 Epub Date: 2024-02-14 DOI: 10.1089/jamp.2023.0039
Ana Flavia Zuim, Aurélie Edwards, Dennis Ausiello, Deen Bhatta, David A Edwards
{"title":"Hypertonic Aerosols Hydrate Airways Longer and Reduce Acidification Risk with Nonpermeating Cation and Permeating Anion Salts.","authors":"Ana Flavia Zuim, Aurélie Edwards, Dennis Ausiello, Deen Bhatta, David A Edwards","doi":"10.1089/jamp.2023.0039","DOIUrl":"10.1089/jamp.2023.0039","url":null,"abstract":"<p><p><b><i>Background:</i></b> Hyperosmolar aerosols appear to promote or suppress upper airway dysfunction caused by dehydration in a composition-dependent manner. We sought to explore this composition dependence experimentally, in an interventional human clinical study, and theoretically, by numerical analysis of upper airway ion and water transport. <b><i>Methods:</i></b> In a double-blinded, placebo-controlled clinical study, phonation threshold pressure (PTP) was measured prenasal and postnasal inhalation of hypertonic aerosols of NaCl, KCl, CaCl<sub>2</sub>, and MgCl<sub>2</sub> in seven human subjects. Numerical analysis of water and solute exchanges in the upper airways following deposition of these same aerosols was performed using a mathematical model previously described in the literature. <b><i>Results:</i></b> PTP decreased by 9%-22% relative to baseline (<i>p</i> < 0.05) for all salts within the first 30 minutes postadministration, indicating effective laryngeal hydration. Only MgCl<sub>2</sub> reduced PTP beyond 90 minutes (21% below baseline at 2 hours postadministration). By numerical analysis, we determined that, while airway water volume up to 15 minutes postdeposition is dictated by osmolarity, after 30 minutes, divalent cation salts, such as MgCl<sub>2</sub>, better retain airway surface liquid (ASL) volume by slow paracellular clearance of the divalent cation. Fall of CFTR chloride flux with rise in ASL height, a promoter of airway acidification, appears to be a signature of permeating cation (NaCl) and nonpermeating anion (mannitol) aerosol deposition. For hypertonic aerosols that lack permeating cation and include permeating anion (CaCl<sub>2</sub> and MgCl<sub>2</sub>), this acid-trigger signature does not exist. <b><i>Conclusions:</i></b> Nonpermeating cation and permeating anion hypertonic aerosols appear to hydrate upper airways longer and, rather than provoke, may reduce laryngeal dysfunction such as cough and bronchoconstriction.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"64-76"},"PeriodicalIF":2.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139735273","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
Practical Considerations in Dose Extrapolation from Animals to Humans. 从动物到人类的剂量外推法的实际考虑因素。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-04-01 Epub Date: 2024-01-17 DOI: 10.1089/jamp.2023.0041
Anthony J Hickey, Sara E Maloney, Phillip J Kuehl, Jonathan E Phillips, Ronald K Wolff
{"title":"Practical Considerations in Dose Extrapolation from Animals to Humans.","authors":"Anthony J Hickey, Sara E Maloney, Phillip J Kuehl, Jonathan E Phillips, Ronald K Wolff","doi":"10.1089/jamp.2023.0041","DOIUrl":"10.1089/jamp.2023.0041","url":null,"abstract":"<p><p>Animal studies are an important component of drug product development and the regulatory review process since modern practices have been in place, for almost a century. A variety of experimental systems are available to generate aerosols for delivery to animals in both liquid and solid forms. The extrapolation of deposited dose in the lungs from laboratory animals to humans is challenging because of genetic, anatomical, physiological, pharmacological, and other biological differences between species. Inhaled drug delivery extrapolation requires scrutiny as the aerodynamic behavior, and its role in lung deposition is influenced not only by the properties of the drug aerosol but also by the anatomy and pulmonary function of the species in which it is being evaluated. Sources of variability between species include the formulation, delivery system, and species-specific biological factors. It is important to acknowledge the underlying variables that contribute to estimates of dose scaling between species.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"77-89"},"PeriodicalIF":3.4,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139490458","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
Dr. Michael Newhouse (March 21, 1935-December 25, 2023), a Global Legacy in Respiratory Medicine and Aerosol Therapy, My Mentor. 迈克尔-纽豪斯博士(1935 年 3 月 21 日-2023 年 12 月 25 日),全球呼吸医学和气溶胶治疗领域的传奇人物,我的导师。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-04-01 Epub Date: 2024-03-13 DOI: 10.1089/jamp.2024.29114.mem
Israel Amirav
{"title":"Dr. Michael Newhouse (March 21, 1935-December 25, 2023), a Global Legacy in Respiratory Medicine and Aerosol Therapy, My Mentor.","authors":"Israel Amirav","doi":"10.1089/jamp.2024.29114.mem","DOIUrl":"10.1089/jamp.2024.29114.mem","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"111-112"},"PeriodicalIF":3.4,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140119520","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
Aerosolizable Pyrazinamide-Loaded Biodegradable Nanoparticles for the Management of Pulmonary Tuberculosis. 用于肺结核治疗的可气溶胶化吡嗪酰胺生物降解纳米粒子。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.1089/jamp.2022.0078
Komal Parmar, Swati Sondarva
{"title":"Aerosolizable Pyrazinamide-Loaded Biodegradable Nanoparticles for the Management of Pulmonary Tuberculosis.","authors":"Komal Parmar, Swati Sondarva","doi":"10.1089/jamp.2022.0078","DOIUrl":"10.1089/jamp.2022.0078","url":null,"abstract":"<p><p><b><i>Background:</i></b> Pyrazinamide is a Biopharmaceutical Classification System class III antibiotic indicated for active tuberculosis. <b><i>Methods:</i></b> In the present work, pyrazinamide-loaded biodegradable polymeric nanoparticles (PNPs) based dry powder inhaler were developed using the double emulsion solvent evaporation technique and optimized using design of experiments to provide direct pulmonary administration with minimal side effects. Batches were characterized for various physicochemical and aerosol performance properties. <b><i>Results:</i></b> Optimized batch exhibited particle size of 284.5 nm, % entrapment efficiency of 71.82%, polydispersibility index of 0.487, zeta potential of -17.23 mV, and <i>in vitro</i> drug release at 4 hours of 79.01%. Spray-dried PNPs were evaluated for drug content, <i>in vitro</i> drug release, and kinetics. The particle mass median aerodynamic diameter was within the alveolar region's range (2.910 μm). In the trachea and lung, there was a 2.5- and 1.2-fold increase in <i>in vivo</i> deposition with respect to pure drug deposition, respectively. <i>In vitro</i> drug uptake findings showed that alveolar macrophages with pyrazinamide PNPs had a considerably higher drug concentration. Furthermore, accelerated stability studies were carried out for the optimized batch. Results indicated no significant change in the evaluation parameters, which showed stability of the formulation for at least a 6-month period. <b><i>Conclusion:</i></b> PNPs prepared using biodegradable polymers exhibited efficient pulmonary drug delivery with decent stability.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"30-40"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402986","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
Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part I-Laboratory Proof-of-Principle. 用临界流量文丘里管管理的流动系统中基于压降测量的已用级联冲击器级的验收测试:第一部分-实验室原理验证。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-02-01 Epub Date: 2023-11-29 DOI: 10.1089/jamp.2023.0035
Daryl L Roberts
{"title":"Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part I-Laboratory Proof-of-Principle.","authors":"Daryl L Roberts","doi":"10.1089/jamp.2023.0035","DOIUrl":"10.1089/jamp.2023.0035","url":null,"abstract":"<p><p><b><i>Background:</i></b> Cascade impactors are essential for measuring the aerodynamic particle size distribution delivered by metered dose, dry powder, and similar inhalable drug products. For quality control of used impactors, periodic optical inspection of the nozzles of each impactor stage (stage mensuration) is currently the only method sufficiently precise to test whether used impactors are suitable for continued use, in accord with pharmacopeial standards. Here, we demonstrate a new method for quality control of used impactors. The method combines stage-wise pressure-drop measurement with a critical flow venturi (CFV) for air flow management. This technique avoids the unacceptably large uncertainty in conventional air flow rate measurements and instead relies on pressure and temperature measurement upstream of the CFV. These measurements can be made precisely with affordable equipment. <b><i>Methods:</i></b> We placed a toroidally shaped CFV downstream of a Next Generation Impactor™** (NGI) and precisely measured the stagnation pressure (±0.02%) and temperature (±0.03%) upstream of this CFV at impactor inlet flow rates close to 60 L/min. Pressure-drop measurements (±0.25%) at stages 3-7 and the micro-orifice collector were made with capacitive diaphragm transducers and with a special lid to the NGI that allowed pneumatic connection to the interstage passageways before and after each impactor stage. <b><i>Results:</i></b> The measured pressure drop values matched, to fractional percentage precision, those predicted by the incompressible flow theory through the nozzles and the compressible flow theory through the CFV. <b><i>Conclusions:</i></b> Practical equipment has been assembled that measures, to fractional percentage precision, the pressure drop through impactor nozzles at precisely managed flow conditions. The experimental results support the relevant flow principles. The results, thereby, support the use of this method for quantifying whether used impactor stages are suitable for continued use in the testing of registered inhalable drug products, in accord with pharmacopeial standards.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"2-10"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138451484","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
Modeling. 建模。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-02-01 Epub Date: 2023-12-05 DOI: 10.1089/jamp.2023.29100.nam
Neil A Miller
{"title":"Modeling.","authors":"Neil A Miller","doi":"10.1089/jamp.2023.29100.nam","DOIUrl":"10.1089/jamp.2023.29100.nam","url":null,"abstract":"<p><p>Modeling is coming to the fore as it is now widely accepted and indeed expected during drug discovery and development. Modeling integrates knowledge, increases understanding and provides the ability to predict an outcome either before it occurs or when it is not possible to measure. This makes modeling an attractive option for inhaled drugs as it is not possible to routinely measure what is occurring to the drug (pharmacokinetics) and what effect the drug is having (pharmacodynamics) at local microscopic sites of such a diverse and complex organ as the lung. Many pieces of information (data and knowledge) exist like the pieces of a jigsaw puzzle and modeling brings the pieces together in a scientific and mechanistically coherent manner to increase understanding of both the efficacy and safety of inhaled drugs.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"41-49"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138487606","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
Acknowledgment of Reviewers 2023. 鸣谢 2023 年审稿人。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-02-01 Epub Date: 2023-12-22 DOI: 10.1089/jamp.2024.29106.ack
{"title":"Acknowledgment of Reviewers 2023.","authors":"","doi":"10.1089/jamp.2024.29106.ack","DOIUrl":"10.1089/jamp.2024.29106.ack","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"37 1","pages":"1"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139712246","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
Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part II-Quantification of the Test Uncertainty Ratio for Pass/Fail Decision-Making under Pharmacopeial Constraints. 用临界流文丘里管管理的流动系统中基于压降测量的已用级联冲击器级的验收测试:第二部分——药典约束下通过/不通过决策的测试不确定比的量化
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2024-02-01 Epub Date: 2023-11-29 DOI: 10.1089/jamp.2023.0036
Daryl L Roberts
{"title":"Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part II-Quantification of the Test Uncertainty Ratio for Pass/Fail Decision-Making under Pharmacopeial Constraints.","authors":"Daryl L Roberts","doi":"10.1089/jamp.2023.0036","DOIUrl":"10.1089/jamp.2023.0036","url":null,"abstract":"<p><p><b><i>Background:</i></b> The pressure drop at any cascade impactor stage is related to the open area of nozzles at that stage. Pressure drop measurement therefore can potentially test whether the nozzles of a given stage are within the range specified for continued use for testing of inhalable drug products. Previous such efforts, however, have been hindered by the measurement precision required for making a pass/fail decision about these used impactors. In this study, we articulate the error analysis for a pressure drop measurement system managed with a critical flow venturi (CFV) and show that the resultant uncertainty in the effective diameter of used Next Generation Impactor (NGI) and Andersen-type impactor stages is generally small compared to the specification range. This result enables the user to make a pass/fail decision regarding suitability for continued use. <b><i>Methods:</i></b> We develop the equations governing the relationship between stage pressure drop and the effective diameter of each stage of a used impactor. These equations show that pressure drop measurements can indicate only the change (if any) in the effective diameter between a previous measurement and the current measurement. Propagation-of-error principles therefore show that the uncertainty of both measurements affects the resulting uncertainty. <b><i>Results:</i></b> The test uncertainty ratio (analytical power) of a CFV-managed pressure drop measurement system exceeds six for all but stage one of the NGI and for stages -1 and -2 of the Andersen-type impactor. The stage-one nozzle of the NGI is readily qualified with a Class X pin. <b><i>Conclusions:</i></b> The CFV-managed flow system described in Part I is sufficiently precise to enable a decision to be made about whether used impactor nozzles are suitable for continued use for testing of registered inhalable drug products. Examination of the industrial viability of the technology will require long-term testing in real-world settings with comparison to optical inspection methods.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"11-18"},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138451483","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
Acknowledgment of Reviewers 2023. 鸣谢 2023 年审稿人。
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2023-12-22 DOI: 10.1089/jamp.2024.29106.ack
{"title":"Acknowledgment of Reviewers 2023.","authors":"","doi":"10.1089/jamp.2024.29106.ack","DOIUrl":"https://doi.org/10.1089/jamp.2024.29106.ack","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2023-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138829850","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
Tracheomalacia Reduces Aerosolized Drug Delivery to the Lung 气管瘘会减少肺部气溶胶给药量
IF 3.4 4区 医学
Journal of Aerosol Medicine and Pulmonary Drug Delivery Pub Date : 2023-12-08 DOI: 10.1089/jamp.2023.0023
C. Gunatilaka, Christopher McKenzie, E. Hysinger, Qiwei Xiao, N. Higano, Jason C. Woods, A. Bates
{"title":"Tracheomalacia Reduces Aerosolized Drug Delivery to the Lung","authors":"C. Gunatilaka, Christopher McKenzie, E. Hysinger, Qiwei Xiao, N. Higano, Jason C. Woods, A. Bates","doi":"10.1089/jamp.2023.0023","DOIUrl":"https://doi.org/10.1089/jamp.2023.0023","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"10 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138589881","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
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