Aerosols In Medicine Research Articles

Interdisciplinary Perspectives on the Role of Aerosol Transmission in SARS-CoV-2 Infections

The relevance of aerosols for the transmission of the Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) is still debated. However, over time, in addition to distancing and hygiene rules, aerosol physics-based measures such as wearing face masks and ventilating indoor spaces were found to be efficient in reducing infections. In an interdisciplinary workshop "Aerosol & SARS-CoV-2" of the Association for Aerosol Research (GAeF) in cooperation with the German Society for Pneumology and Respiratory Medicine (DGP), the Professional Association of General Air Technology of the VDMA, the German Society for Virology (GfV), the Health Technology Society (GG) and the International Society for Aerosols in Medicine (ISAM) under the auspices of the Robert Koch Institute (RKI) in March 2021, the need for research and coordination on this topic was addressed. Fundamental findings from the various disciplines as well as interdisciplinary perspectives on aerosol transmission of SARS-CoV-2 and infection mitigation measures are summarized here. Finally, open research questions and needs are presented.

Regional Deposition: Targeting.

Patterns of regional aerosol deposition within the lungs are known to vary in a predictable manner with a number of factors, most notably aerodynamic particle size and inhalation pattern. Targeting deposition involves the intentional manipulation of one or more of these factors to promote aerosol deposition in certain locations within the respiratory tract. This section will begin by exploring existing evidence supporting the need to target regional deposition. Thereafter, various approaches to targeting will be introduced. In addition to control of aerodynamic particle size and inhalation pattern, a collection of approaches are available through which to passively target deposition to more central or peripheral lung regions. These include the delivery of short aerosol boluses at prescribed time points in inhalation, control of transient hygroscopic aerosol size changes during transport through the respiratory tract, and use of alternative carrier gas mixtures such as helium/oxygen mixtures. Comparatively, targeting aerosol deposition locally to very precise, spatially-defined lung regions is in its infancy. Early, exploratory techniques used for local targeting will be described. The continued evolution of deposition targeting towards ever more specific locations within the lungs is required to explore fundamental research questions in aerosol medicine: namely, how precise does targeting need to be before additional refinement fails to produce appreciably different therapeutic effects, and which nascent applications of aerosols in medicine might benefit from more selective regional targeting?

Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine.

National and international guidelines recommend droplet/airborne transmission and contact precautions for those caring for coronavirus disease 2019 (COVID-19) patients in ambulatory and acute care settings. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, an acute respiratory infectious agent, is primarily transmitted between people through respiratory droplets and contact routes. A recognized key to transmission of COVID-19, and droplet infections generally, is the dispersion of bioaerosols from the patient. Increased risk of transmission has been associated with aerosol generating procedures that include endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, turning the patient to the prone position, disconnecting the patient from the ventilator, noninvasive positive-pressure ventilation, tracheostomy, and cardiopulmonary resuscitation. The knowledge that COVID-19 subjects can be asymptomatic and still shed virus, producing infectious droplets during breathing, suggests that health care workers (HCWs) should assume every patient is potentially infectious during this pandemic. Taking actions to reduce risk of transmission to HCWs is, therefore, a vital consideration for safe delivery of all medical aerosols. Guidelines for use of personal protective equipment (glove, gowns, masks, shield, and/or powered air purifying respiratory) during high-risk procedures are essential and should be considered for use with lower risk procedures such as administration of uncontaminated medical aerosols. Bioaerosols generated by infected patients are a major source of transmission for SARS CoV-2, and other infectious agents. In contrast, therapeutic aerosols do not add to the risk of disease transmission unless contaminated by patients or HCWs.

Рossibilities of clinical application of modern nebulizers

The simplicity of converting medicinal solutions and suspensions into aerosols using mechanical and thermal energy, convenient delivery to the airways allows nebulizers to take a worthy place in the treatment of hospitalized and outpatient patients. Different types of nebulizers are available for use in the home and in medical settings (jet, ultrasound, membrane), and researches show that the performance and characteristics of the aerosol vary between different devices and manufacturers. Jet nebulizers are still the most used devices that do not require coordination of inhale and delivery of aerosol to the respiratory tract. To reduce the consumption of medicinal aerosol and optimize the air flow, virtual valve technology (V.V.T.) is being improved, and breath-actuated nebulizers are being created. The advantage of nebulizer therapy is the ability to apply large doses of medications, use substances that exist only in inhaled form. The choice falls on the nebulizer in cases where the patient can not use other delivery devices, for example, if the patient is unable to coordinate the inhalation and intake of the drug into the respiratory tract, with a severe exacerbation of obstructive disease, in the presence of motor disorders. The optimal delivery device for children of any age, including newborns, is a nebulizer. The most common indication for nebulizer therapy is the delivery of bronchodilators and inhaled corticosteroids for asthma or chronic obstructive pulmonary disease, as well as the treatment of upper respiratory tract diseases, in particular croup in children. An important place is given to nebulizers when it is necessary to prescribe certain mucolytics and antibiotics. In the treatment of emergency conditions, inhalation administration of drugs may be required, including situations when the patient is on mechanical ventilation or has a tracheostomy installed. The significance of nebulizers in the treatment of cystic fibrosis, pulmonary arterial hypertension, and alpha-1-antitrypsin deficiency is being studied. The possibilities of endobronchial delivery of heparin, insulin, and monoclonal antibodies are evaluated.

Reflections on Digital Health Tools for Respiratory Applications.

Background: In May 2019, the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) held a one-day workshop on digital health tools for respiratory therapies, with speakers representing views of patients, pharmaceutical and technology companies, physicians, and payors. Methods: Workshop presentations, audience discussions, and research of relevant literature form the basis of this article. Results: Conversations and publications to date illustrate the broad, and growing, interest in digital technologies, but also highlight a few gaps. The key messages are: (1) There are many great technologies, from simple to complex, but there is still an imperfect understanding of the problems that digital tools need to solve. The current approach often starts with a technology "solution" and then identifying the problems that it could address. This is a poor design practice: the offered technology may not represent the optimum solution to that problem; and that "problem" itself may not represent issues that patients or the health care system deem to be of high priority. (2) Respiratory medicine currently lacks widely accepted and easily measured biomarkers or hand-held diagnostic technologies that could be commercialized for complex/heterogeneous diseases such as asthma (unlike in other areas, e.g., diabetes). (3) There are no obvious solutions that integrate the perspectives of the many stakeholders-from patients to physicians to payors-to make the new field commercially viable, and the incentives of various parties in the health care system are misaligned. (4) A continued dialog, information sharing, mutual education, and collaborations are important in bringing the promise of digital respiratory medicine to fruition. Conclusions: Digital tools for diagnosis and management of respiratory conditions are an active area of research and development but long-term success in this field will depend on identifying real needs, and integrating the often-diverging interests of the various partners in each country's health care system.

Simulation of the deposition of aerosol droplets in a person’s bronchial tree

The work is devoted to the mathematical construction of the human bronchial tree, calculating the flow of gas in the lungs and modelling the deposition of drops of medicinal aerosols in the human bronchial tree. Analytically built a symmetrical human bronchial tree. To calculate the flow of gas in the lungs and the deposition of aerosols, the method of phasing out the flow in one branch of the bronchial tree is used. Three-dimensional numerical calculations of air flow and aerosol droplets in human lungs were carried out. It is shown that the number of past drops depends (except for the flow, size of drops) on the duration of inhalation.

Abstracts of International Society for Aerosols in Medicine e.V. 22nd ISAM Congress Montreux, Switzerland May 25–29, 2019

Abstracts of International Society for Aerosols in Medicine e.V. 22nd ISAM Congress Montreux, Switzerland May 25–29, 2019

Pulmonary Delivery of Therapeutic and Diagnostic Gases.

The 21st Congress for the International Society for Aerosols in Medicine included, for the first time, a session on Pulmonary Delivery of Therapeutic and Diagnostic Gases. The rationale for such a session within ISAM is that the pulmonary delivery of gaseous drugs in many cases targets the same therapeutic areas as aerosol drug delivery, and is in many scientific and technical aspects similar to aerosol drug delivery. This article serves as a report on the recent ISAM congress session providing a synopsis of each of the presentations. The topics covered are the conception, testing, and development of the use of nitric oxide to treat pulmonary hypertension; the use of realistic adult nasal replicas to evaluate the performance of pulsed oxygen delivery devices; an overview of several diagnostic gas modalities; and the use of inhaled oxygen as a proton magnetic resonance imaging (MRI) contrast agent for imaging temporal changes in the distribution of specific ventilation during recovery from bronchoconstriction. Themes common to these diverse applications of inhaled gases in medicine are discussed, along with future perspectives on development of therapeutic and diagnostic gases.

Abstracts: International Society for Aerosols in Medicine e.V. 21st ISAM Congress Santa Fe, NM June 3-7, 2017.

Abstracts: International Society for Aerosols in Medicine e.V. 21st ISAM Congress Santa Fe, NM June 3-7, 2017.

Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop.

This article reports on discussions at the 2015 workshop cosponsored by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and the International Society for Aerosols in Medicine (ISAM), entitled "Regulatory and Patient Considerations for Inhalation Device Design, Development and Use." Key topics addressed at the workshop and presented here include patient-focused device design for orally inhaled products (OIPs), instructions for use (IFU), human factors, regulatory considerations in the United States and Europe, development of generic inhalers, quality-by-design, and change management of OIP devices. Workshop participants also identified several areas for further consideration and emphasized the need for increased focus on the patient to create therapeutic products (inclusive of device design, IFU, education, training) that support adherence with an individual patient's treatment regimen. Advances in patient-centric product development will require engagement and collaboration by industry, regulators, patients, physicians, and other stakeholders. The article includes summaries of presented talks as well as of panel and audience discussions.

Abstracts: International Society for Aerosols in Medicine e.V.20th ISAM CongressMunich Holiday Inn-City Center, Germany May 30–June 3, 2015

Abstracts: International Society for Aerosols in Medicine e.V.20th ISAM CongressMunich Holiday Inn-City Center, Germany May 30–June 3, 2015

Aerosol Delivery of Orally Inhaled Agents

Deposition scintigraphy methods have been used extensively to provide qualitative and quantitative data on aerosol drug deposition in the lungs. However, differences in methodology among the different centers performing these studies have limited the application of these techniques, especially in regulatory roles. As an introduction to the standardized techniques developed by the International Society for Aerosols in Medicine (ISAM) Regulatory Affairs Networking Group, we present potential advantages of the use of standard techniques for deposition scintigraphy. Specifically, we propose that standardized techniques would allow for better comparisons between labs and would facilitate multicenter studies. They would allow for improved methods of establishing equivalence and could be better utilized to establish dosing for new medications. They would allow for the performance of more accurate dose ranging or multidose studies and complement pharmacokinetic studies of new inhaled medications. Standardized techniques could help to establish the relationship between the deposition of drug in the lungs and clinical effect, and may also facilitate clinical measurements of deposited dose for medications with narrow therapeutic indices. In the sections that follow, we discuss the best techniques used to perform deposition scintigraphy through planar, single-photon emission computed tomography, and positron emission tomography modalities and propose a detailed set of standardized methods for each. These include methods for radiolabel validation, radiolabel accountability and mass balance, and imaging acquisition and analysis.

Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report

The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.

Conference Report: the 18th Congress of the International Society for Aerosols in Medicine

The 18th biennial Congress of ISAM was held for 4 days at the De Doelen Congress Centre, Rotterdam, Netherlands, at which approximately 350 delegates, including 60 session chairs and speakers, attended. The abstracts of the 49 podium talks and the 126 posters that were presented have been published in the society's technical journal (journal of Aerosol Medicine and Pulmonary Delivery), and the detailed program can be found on the ISAM website (www.isam.org). Postgraduate courses on the topics: 'Inhalation Therapy at the Intensive Care Unit'; 'Walking the Standards Maze: Standards for Device Development, Device Performance and Regulatory Approval'; and 'Nuts and Bolts of Aerosol Delivery: Theory, Guidelines and Practice', were offered to participants prior to the Congress itself.

What the pulmonary specialist should know about the new inhalation therapies

A collaboration of multidisciplinary experts on the delivery of pharmaceutical aerosols was facilitated by the European Respiratory Society (ERS) and the International Society for Aerosols in Medicine (ISAM), in order to draw up a consensus statement with clear, up-to-date recommendations that enable the pulmonary physician to choose the type of aerosol delivery device that is most suitable for their patient. The focus of the consensus statement is the patient-use aspect of the aerosol delivery devices that are currently available. The subject was divided into different topics, which were in turn assigned to at least two experts. The authors searched the literature according to their own strategies, with no central literature review being performed. To achieve consensus, draft reports and recommendations were reviewed and voted on by the entire panel. Specific recommendations for use of the devices can be found throughout the statement. Healthcare providers should ensure that their patients can and will use these devices correctly. This requires that the clinician: is aware of the devices that are currently available to deliver the prescribed drugs; knows the various techniques that are appropriate for each device; is able to evaluate the patient's inhalation technique to be sure they are using the devices properly; and ensures that the inhalation method is appropriate for each patient.

In vitro aerosol characterization of Staccato® Loxapine

Medicinal aerosol products (metered dose and dry powder inhalers) require characterization testing over a wide range of use and pre-operating stress scenarios in order to ensure robust product performance and support submissions for regulatory approval. Aerosol characterization experiments on Staccato® Loxapine for inhalation (Staccato Loxapine) product (emitted dose, particle size, and purity) were assessed at different operating settings (flow rates, ambient temperature and humidity, altitude, and orientation) and at nominal test conditions following exposure to various stresses on the device (mechanical shock, vibration, drop, thermal cycling, and light exposure). Emitted dose values were approximately 90% of the coated dose at every condition, meeting target specifications in each case. Aerosol purity was consistently >99.5% for every test setting, with no reportable impurities according to ICH standards (>0.1%). Particle size averaged 2μm (MMAD) and was independent of the different test conditions with the exception of different airflow rates. Particle size decreased slightly with airflow, which may assist in maintaining constant deep lung deposition. The combination of high emitted dose efficiency and a particle size range ideally suited for lung deposition, along with the consistency of these key aerosol attributes, suggests that the Staccato system has distinct advantages over more traditional aerosol systems.

Modification of inhalable powders by pulmonary surfactant components adsorbed on droplets during spray-drying process

Inhalation of medicinal aerosols requires the specific properties of powders to assure their de-aggregation to particles within the respirable size. In this study we evaluate the influence of additives of pulmonary surfactant (PULMS) components in lactose solution used for preparation of powders by pneumatic atomization and the consecutive spray-drying (SD). It was demonstrated that PULMS in a low concentration (0.1%) changed the morphology of powder particles and improved their aerosolization properties in comparison to spray-dried lactose obtained in similar conditions. The mass median diameter of lactose/PULMS aerosol particles released from a commercial inhaler was reduced to 6.6 μm when compared to the value of 17.2 μm for lactose. At the same time the fraction of particles smaller than 5 μm was increased to 37% (from ca. 7% for lactose). These results were attributed to PULMS adsorption on droplets generated during SD process. Moreover, the particles appeared to be very effective in reducing the dynamic surface tension after dissolution in water what indicates that PULMS components are effectively incorporated into powder particles obtained by SD. This effect not only improves properties of inhalable powder but simultaneously allows to deliver PULMS to the lungs where it can act as an absorption enhancer of inhaled medicines.

International Society for Aerosols in Medicine, 17th Congress, 10 – 14 May 2009, Monterey, California, USA

The 17th biennial congress of the International Society for Aerosols in Medicine (ISAM) was held in Monterey, California, between 10 and 14 May 2009. The congress was attended by ∼ 300 delegates from 18 countries. Podium presentations were focused on advances in pulmonary drug delivery, but clearance of materials from the lungs by a variety of processes and the potential harmful effects of inhaled particles were also covered. There were > 100 proffered posters, and a commercial exhibition in which 20 companies displayed their products. There were excellent networking opportunities, and the inauguration of more formal networking groups will allow dialogue to continue. s of podium and poster presentations were provided in the Journal of Aerosol Medicine and Pulmonary Drug Delivery, and it is likely that some of the podium presentations will appear as full papers in that journal in due course. The next conference in this series takes place in Rotterdam, The Netherlands, in June 2011.

Changes of water solution properties under the processes of their ultrasonic atomization

Transformation of diluted water solutions of medicines into medicinal aerosols in ultrasonic inhalers leads to variation of concentration ratios for solution components in an aerosol and appearance of new substances synthesized usually in the process of cavitation in water solutions. It is demonstrated that for the characteristic concentrations of solution components intended for aerosol therapy the effect of concentration of its surface-active components is most significant in the process of ultrasonic dispersion into an aerosol. This effect must be taken into account in medical practice.

Sizing Evaporative Aerosols: The “Man with Too Many Watches” Dilemma

Journal of Aerosol Medicine and Pulmonary Drug DeliveryVol. 22, No. 1 EditorialsSizing Evaporative Aerosols: The “Man with Too Many Watches” DilemmaWilliam D. Bennett and Kirby L. ZemanWilliam D. BennettSearch for more papers by this author and Kirby L. ZemanSearch for more papers by this authorPublished Online:6 Mar 2009https://doi.org/10.1089/jamp.2008.0732AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail "Sizing Evaporative Aerosols: The “Man with Too Many Watches” Dilemma." , 22(1), pp. 3–4FiguresReferencesRelatedDetailsCited byAerodynamic characteristics of nebulized terbutaline sulphate using the Andersen Cascade Impactor compared to the Next Generation Impactor25 January 2010 | Pharmaceutical Development and Technology, Vol. 16, No. 2International Society for Aerosols in Medicine, 17th Congress, 10 – 14 May 2009, Monterey, California, USA28 July 2009 | Expert Opinion on Drug Delivery, Vol. 6, No. 8 Volume 22Issue 1Mar 2009 InformationMary Ann Liebert, Inc.To cite this article:William D. Bennett and Kirby L. Zeman.Sizing Evaporative Aerosols: The “Man with Too Many Watches” Dilemma.Journal of Aerosol Medicine and Pulmonary Drug Delivery.Mar 2009.3-4.http://doi.org/10.1089/jamp.2008.0732Published in Volume: 22 Issue 1: March 6, 2009PDF download