Abraham Bohadana, Amir Jarjoui, Rona Lujan, Sabri Jaffal, Ariel Rokach, Gabriel Izbicki
{"title":"Inhaler Technique, Critical Errors, and Effective Inspiratory Flow in COPD Patients: A Prospective Study Comparing Patients Over and Under 65 Years of Age.","authors":"Abraham Bohadana, Amir Jarjoui, Rona Lujan, Sabri Jaffal, Ariel Rokach, Gabriel Izbicki","doi":"10.1089/jamp.2025.0002","DOIUrl":"https://doi.org/10.1089/jamp.2025.0002","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Proper inhaler use is critical to the management of chronic obstructive pulmonary disease (COPD), and age plays a significant role in determining the appropriate device. This study evaluated inhaler technique, critical errors, and peak inspiratory flow (PIF) required to activate the inhaler in elderly patients with COPD. <b><i>Methods:</i></b> A total of 81 patients with COPD, 41 aged ≤65 years and 40 aged >65 years, using at least one pressurized metered-dose inhaler (pMDI), dry powder inhaler (DPI), or soft mist inhaler (SMI) were included in the study. Inhaler technique was assessed using a checklist and critical errors were identified. PIF was measured with the In-Check DIAL device and compared with the optimal reference value for each type of inhaler. <b><i>Results:</i></b> Patients over 65 years of age had lower technique scores (<i>p</i> < 0.001) and a higher incidence of critical errors (<i>p</i> < 0.001) compared with younger patients. Older patients using three inhalers had lower technique scores than those using one or two inhalers (<i>p</i> < 0.001) and had five times more critical errors than younger patients (<i>p</i> < 0.02). A strong correlation between the number of critical errors and technique score was observed in the older group (<i>r</i> = 0.74; <i>p</i> < 0.001). In both groups, critical errors were identified in patients with good or high technical score. With the exception of four older patients, all participants, regardless of age or obstruction severity, achieved the required PIF for proper inhaler activation. <b><i>Conclusion:</i></b> In conclusion, patients over 65 years of age with COPD showed a tendency to misuse inhalers, especially pMDIs and multiple inhalers. Patients with adequate or high technique scores in both age groups made critical errors highlighting the importance of investigating the nature of the error regardless of the technique score. By considering the minimum flow value for each inhaler, almost all patients were able to achieve an effective PIF for inhaler activation.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078116","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}
Maciej Kupczyk, Michał Panek, Hosein Sadafi, Wilfried De Backer, Maciej Wojakiewicz, Tomasz Dębowski
{"title":"Lung Deposition of Extrafine Versus Nonextrafine Aerosols at Low Inhalation Flow Rates in Adult Asthma Patients: A Composition Study.","authors":"Maciej Kupczyk, Michał Panek, Hosein Sadafi, Wilfried De Backer, Maciej Wojakiewicz, Tomasz Dębowski","doi":"10.1089/jamp.2024.0052","DOIUrl":"https://doi.org/10.1089/jamp.2024.0052","url":null,"abstract":"<p><p><b><i>Backgroud:</i></b> A key attribute in selecting an oral inhaler device for chronic obstructive pulmonary disease (COPD) and asthma is its ability to dispense a high degree of pulmonary deposition of the drug at low inspiratory flows. <b><i>Methods:</i></b> In this study, the lung deposition of extrafine formulations of beclomethasone dipropionate (BDP) and formoterol fumarate (FF) (pressurized metered-dose inhaler [pMDI] and dry powder inhaler [DPI], NEXThaler) was compared with that of nonextrafine formulations of fluticasone/salmeterol (FP/SAL) Diskus DPI and budesonide/formoterol (BUD/FF) Turbuhaler DPI in 10 patients. Diskus intrathoracic (peripheral and central) lung deposition was estimated at low inhalation flow rates (30 and 40 L/min) <i>via</i> validated functional respiratory imaging (FRI) and computational fluid dynamics (CFD) methods. <b><i>Results:</i></b> The BDP/FF NEXThaler and BDP/FF pMDI had the highest median percentages of intrathoracic deposition, with consistent mean values of approximately 50% and 40%, respectively. The median percentage of peripheral deposition from extrafine inhalers was above 30% with BDP/FF NEXThaler and pMDI, 5% or less with the FP/SAL Diskus at both flow rates, and ranged between 12% and 22% with the BUD/FF Turbuhaler DPI at flow rates of 30 and 40 L/min, respectively. <b><i>Conclusions:</i></b> Extrafine BDP/FF using NEXThaler and pMDI resulted in greater peripheral deposition of both the inhaled corticosteroid and long-acting beta-agonists moieties than the nonextrafine FP/SAL Discus and BUD/FF DPIs did.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991262","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}
Barbara Rothen-Rutishauser, Chantal Darquenne, David Cipolla, Omar Usmani
{"title":"History of the International Society of Aerosols in Medicine (ISAM): Celebrating the 25th Congress.","authors":"Barbara Rothen-Rutishauser, Chantal Darquenne, David Cipolla, Omar Usmani","doi":"10.1089/jamp.2025.0007","DOIUrl":"https://doi.org/10.1089/jamp.2025.0007","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002055","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}
Worth Longest, Michael Hindle, Dale Farkas, Mohammad A M Momin, Caleb Dalton, Felicia Hall, Ghali Aladwani, Hattie KenKnight, Robert M DiBlasi
{"title":"Preclinical Testing of a New Dry Powder Aerosol Synthetic Lung Surfactant Formulation and Device Combination for the Treatment of Neonatal Respiratory Distress Syndrome.","authors":"Worth Longest, Michael Hindle, Dale Farkas, Mohammad A M Momin, Caleb Dalton, Felicia Hall, Ghali Aladwani, Hattie KenKnight, Robert M DiBlasi","doi":"10.1089/jamp.2025.0001","DOIUrl":"https://doi.org/10.1089/jamp.2025.0001","url":null,"abstract":"<p><p><b><i>Background:</i></b> This study advanced the preclinical development of a new dry powder aerosol synthetic lung surfactant (SLS) product for neonatal respiratory distress syndrome (RDS) by integrating a multiple-actuation device and scalable spray-dried formulation, evaluating physicochemical and <i>in vitro</i> aerosol performance, and then comparing biological efficacy with the current clinical standard of high-volume liquid bolus instillation. <b><i>Methods:</i></b> A new high-dose air-jet dry powder inhaler was developed that was characterized by a variable-volume aerosolization chamber (D3 device) with the goal of unifying aerosol quality and emitted dose (ED) over multiple actuations. The SLS excipient enhanced growth dry powder formulation was advanced through production on a scalable nozzle-based spray dryer system (Mini Spray Dryer; MSD2 formulation). Physicochemical characterization of the formulation was performed along with <i>in vitro</i> aerosol testing of the new D3-MSD2 device and formulation combination. The optimized D3-MSD2 aerosol therapy was then evaluated in a rabbit model of severe RDS. <b><i>Results:</i></b> The new D3-MSD2 combination produced a small-particle aerosol with high fine particle fraction (FPF<sub><5 µm</sub> = 87.9%; FPF<sub><2.5 µm</sub> = 61.6%) and percent ED (77.4% of loaded). Additional <i>in vitro</i> testing highlighted consistent particle size (D<sub>v50</sub> = 1.6 µm) and ED across multiple actuations. In the animal model experiments, a total device-loaded formulation mass of 60 mg (delivered as 2x30 mg) produced a total phospholipid (PL) dose of 24 mg-PL/kg and a device ED of 18 mg-PL/kg compared with the 200 mg-PL/kg clinical dose of Curosurf liquid. <i>In vivo</i> response rate for the D3-MSD2 aerosol therapy was considerably more rapid with arterial oxygenation recovering 5-12 times faster than for liquid Curosurf. Biological response for the D3-MSD2 aerosol therapy was also superior with 2-fold improvement in final lung compliance compared with liquid Curosurf. <b><i>Conclusions:</i></b> The new D3-MSD2 aerosol therapy was found to be superior to clinical-practice liquid bolus instillation in the critical areas of required dose (order-of-magnitude reduction), delivery time, biological response rate, and efficacy.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965555","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}
Conor A Ruzycki, Scott Tavernini, George Luciuk, Kevin W Stapleton, Warren H Finlay, Andrew R Martin
{"title":"The Influence of Pressurized Metered Dose Inhaler Actuator Orifice Diameter on Regional Extrathoracic Deposition of Inhaled Epinephrine.","authors":"Conor A Ruzycki, Scott Tavernini, George Luciuk, Kevin W Stapleton, Warren H Finlay, Andrew R Martin","doi":"10.1089/jamp.2024.0039","DOIUrl":"https://doi.org/10.1089/jamp.2024.0039","url":null,"abstract":"<p><p><b><i>Background:</i></b> Extrathoracic deposition is a large source of <i>in vivo</i> variability in dosing for pressurized metered dose inhaler (pMDI) aerosols. A majority of previous studies have focused on only total extrathoracic deposition for pMDIs. The present work evaluates regional deposition within the extrathoracic region to better understand the impact of actuator orifice diameter and inhalation flow rate on extrathoracic deposition of a suspension pMDI formulation of epinephrine. <b><i>Methods:</i></b> Regional deposition of a commercially available HFA (hydrofluoroalkane) suspension pMDI formulation of epinephrine was evaluated using plastic and metal versions of the newly developed sectioned Alberta Idealized Throat (s-AIT), divided into analogs of the oral cavity, the pharynx/larynx, and the upper trachea. Influences of actuator orifice diameter and inhaler insertion angle on regional extrathoracic deposition were evaluated in the plastic s-AIT at a 30 L/min flow rate, followed by additional testing in the metal s-AIT to evaluate effects across a range of flow rates (from 10 to 100 L/min). <b><i>Results:</i></b> Actuator orifice was found to strongly influence regional extrathoracic deposition of a commercially available epinephrine HFA suspension pMDI aerosol, with smaller actuator orifices yielding reduced oral cavity deposition and increased distal-filter (<i>in vitro</i> lung) deposition in both the plastic and metal s-AIT. Inhalation flow rate was found to strongly influence deposition in the metal s-AIT, with higher flow rates associated with reduced oral cavity deposition, increased pharynx/larynx deposition, and increased upper trachea deposition. Smaller orifices showed less variability in results as a function of inhaler insertion angle. <b><i>Conclusions:</i></b> Actuator orifice diameter (spanning 0.22-0.42 mm) can strongly influence regional deposition of an HFA epinephrine suspension pMDI aerosol within the extrathoracic region. Smaller actuator orifices may provide reduced oral cavity deposition and increased delivery to the lungs. Smaller actuator orifices may also reduce variability in extrathoracic deposition that is associated with patient use aspects such as inhaler insertion angle.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997211","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}
Michal Leibovitch, Bernice Oberman, Jacob Cohen, Tamar Strahl, Noga Yosef, Yael Reichenberg, Dekel Shlomi
{"title":"Association of Inhaled Corticosteroid Use with COVID-19 Severity and Hospitalization in Patients With and Without Respiratory Disease.","authors":"Michal Leibovitch, Bernice Oberman, Jacob Cohen, Tamar Strahl, Noga Yosef, Yael Reichenberg, Dekel Shlomi","doi":"10.1089/jamp.2025.0004","DOIUrl":"https://doi.org/10.1089/jamp.2025.0004","url":null,"abstract":"<p><p><b><i>Background:</i></b> Several studies have demonstrated the benefit of inhaled corticosteroids (ICS) before COVID-19 illness in reducing hospitalization time and reducing viral entrance to lung cells. This study explores the risk of severe COVID-19 illness among patients who had purchased ICS. <b><i>Methods:</i></b> In a retrospective study, adult patients with COVID-19 before the emergence of the Omicron variant were included. The severity, hospitalization rates, and mortality due to COVID-19 among patients who purchased and did not purchase ICS during the 6 months before the illness were compared. <b><i>Results:</i></b> Of the 44,866 COVID-19 patients, 2359 (5.3%) were hospitalized. Information regarding the severity of hospitalization was available for 2259 patients. Of these, 602 (27%) were classified as having severe disease and 510 (22%) died. Patients with higher socioeconomic status (SES) had less hospitalization rates but significantly higher risk for severe COVID-19 and a higher mortality rate. In a multivariate analysis, a significantly higher risk for hospitalization was found only for patients who purchased ICS when no respiratory disease was recorded (odds ratio 1.53,95% confidence interval: 1.15-2.01), relative to those who did not purchase ICS. <b><i>Conclusions:</i></b> Patients with unrecorded respiratory disease who purchased ICS are at higher risk for hospitalization due to COVID-19; therefore, rigorous attempts should be made to better characterize their illness. Higher SES was associated with more severe COVID-19 and higher mortality rates and these patients should have early hospitalization.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144017721","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}
David Ney Gonzalez, Martijn Grinovero, Luca Ponti, Cristina Cova, Valeria Sesana, Marco Franza, Mauro Citterio, Yannick Baschung
{"title":"Respiratory Therapy with Digital Inhalers: Insights from Multimodal Experimental and <i>In Vitro</i> Analysis.","authors":"David Ney Gonzalez, Martijn Grinovero, Luca Ponti, Cristina Cova, Valeria Sesana, Marco Franza, Mauro Citterio, Yannick Baschung","doi":"10.1089/jamp.2024.0042","DOIUrl":"https://doi.org/10.1089/jamp.2024.0042","url":null,"abstract":"<p><p><b><i>Background:</i></b> The RS01X is a digital dry powder inhaler (DPI) that records inhalation parameters such as technique or adherence. This offers patients and health care providers a way to have a feedback on inhalation treatments. This study used real-life data gained from 28 healthy volunteers for adherence assessment, technique evaluation, and <i>in vitro</i> testing. <b><i>Methods:</i></b> The study enrolled 28 healthy volunteers. Participants were shown how to use an inhaler and provided with empty capsules. The inhalers record several inhalation parameters such as peak inspiratory flow (PIF), volume, duration, and orientation. Half of the participants were selected to be in an \"intervention\" group with access to their inhalation data as well as feedback to improve their inhalation. The other half were a \"control\" group without access to their data nor any feedback. The data were then used for <i>in vitro</i> testing. <b><i>Results:</i></b> Overall, 28 participants were enrolled, and inhalation data were available for 13 interventions and 15 controls. Average adherence was 82.0% and 69.5% for intervention and control, respectively. The technique of inhalation was 65.58% good, 19.89% fair, and 14.53% poor for the intervention group and 36.73% good, 26.99% fair, and 36.28% poor for the control group. The variability of PIF was 9% for intervention and 30% for control. <i>In vitro</i> simulations showed the importance of proper angle orientation in inhalation, which was supported by <i>in vivo</i> data. The fine particle fraction of active pharmaceutical ingredients was similar to the inhalation profile of the intervention in comparison with a theoretical perfect inhalation. <b><i>Conclusion:</i></b> This study results showed clear improvement in inhalation technique and adherence for patients using digital DPI. In addition, <i>in vitro</i> testing provided concrete data illustrating the measurable advancements digitalization offers in enhancing patient adherence and inhalation technique.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010457","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}
David Cipolla, Christopher J Gruenloh, Nani Kadrichu, Philip J Kuehl, Lei Mao, Bing V Li, Svetlana Lyapustina, Heidi M Mansour, Franz-Josef K Rehmann, Irene Rossi, Gur Jai Pal Singh, Julie D Suman, Nurcin Ugur
{"title":"Inhalable and Nasal Biologics: Analytical, Formulation, Development, and Regulatory Considerations.","authors":"David Cipolla, Christopher J Gruenloh, Nani Kadrichu, Philip J Kuehl, Lei Mao, Bing V Li, Svetlana Lyapustina, Heidi M Mansour, Franz-Josef K Rehmann, Irene Rossi, Gur Jai Pal Singh, Julie D Suman, Nurcin Ugur","doi":"10.1089/jamp.2024.0058","DOIUrl":"https://doi.org/10.1089/jamp.2024.0058","url":null,"abstract":"<p><p><b><i>Background:</i></b> Delivering large molecules and biologics via inhalation or intranasal routes allows these innovative therapies to directly target the respiratory tract, access the richly vascularized lymphatic tissue in the nose for vaccination, bypass gastro-intestinal and first-pass hepatic metabolism for systemically active drugs, and provide a convenient alternative to injections. These advantages are driving significant growth in research and development within this field. However, before such products can reach the market, they must undergo rigorous nonclinical studies and clinical trials and address challenges related to formulation, manufacturing, analytical testing, quality standards, and regulatory review. <b><i>Methods and Results:</i></b> This report summarizes discussions among leading experts from industry, academia, and regulatory bodies on how to apply general Chemistry, Manufacturing, and Controls (CMC) principles, alongside bioequivalence (BE) considerations, to the development of inhalable and nasal biologics (INBs). It also explores the balance between these requirements and the established techniques for medical aerosols. In the absence of explicit regulatory guidelines for the development of INBs, this article reviews applicable literature, including guidelines from the US FDA and EMA for biologics, on the one hand, and for small-molecule inhalation and nasal drug products, devices, and combination products, on the other. The original discussions reflected here took place at the 2023 workshop co-organized by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Subsequent recent developments have also been added. The article describes regulatory expectations, the selection of delivery systems and formulation types, and analytical techniques for assessing product quality attributes of INBs. Several specific cases are presented in detail, including regulatory considerations for generic peptides, the approval package for one of the first marketed biologics for inhalation, and analytical detection strategies for viral-based products delivered to the lungs. <b><i>Conclusions:</i></b> Looking ahead, the future of INBs includes opportunities to treat and potentially cure diseases that currently have no effective treatment or that require repeated injections. Continued collaboration among researchers, developers and regulators will be key to advancing these therapies, ultimately benefiting patients and improving health outcomes. The future of INBs looks promising!.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803553","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":"Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations.","authors":"Gur Jai Pal Singh, S Prasad Peri","doi":"10.1089/jamp.2024.0036","DOIUrl":"10.1089/jamp.2024.0036","url":null,"abstract":"<p><p>Approved drug products may be subject to change(s) for a variety of reasons. The changes may include, but are not limited to, increase in batch size, alteration of the drug product constituent(s), improvement in the manufacturing process, and shift in manufacturing sites. The extent of pharmaceutical testing and the regulatory pathway for timely implementation of any change in the approved product and/or process depends upon the nature and extent of change. The U.S. Food and Drug Administration (FDA) has published guidelines that outline its expectations for the Scale-Up and Postapproval Changes (SUPAC) in the solid oral immediate and modified release (MR) products, and semisolid formulations. However, to date, no such guidelines have been issued to address SUPAC in the orally inhaled drug products (OIDPs), and this article represents a seminal contribution in this direction. It is hoped that it will inspire contributions from the relevant multidisciplinary experts from the pharmaceutical industry and the agency in accomplishing formal regulatory guidelines relevant to the OIDP SUPAC. The OIDPs are complex drug-device combination products. Therefore, a conceptualization of SUPAC guidelines for these products warrants consideration of contributions of effect of change(s) in individual components (drug substance, formulation, device) as well as a compound effect that a single or multiple changes may have on product performance, and its safety and efficacy. This article provides a discussion of scientific aspects and regulatory bases relevant to the development of SUPAC for OIDPs, and it attempts to outline considerations that may be applicable in addressing issues related to the OIDP SUPAC in the context of human drugs. The authors' statements should not be viewed as recommendations from any regulatory agency, as the applicable guidelines would be determined on case-by-case evaluation by the relevant authorities.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"39-63"},"PeriodicalIF":2.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794600","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":"Inhaled Chemotherapy.","authors":"Janakiraman Subramanian, Rajiv Dhand","doi":"10.1089/jamp.2025.19211.js","DOIUrl":"10.1089/jamp.2025.19211.js","url":null,"abstract":"<p><p>Cytotoxic chemotherapy remains the cornerstone of treatment for patients diagnosed with advanced stage cancers and is an important component in the multi-disciplinary treatment of several early stage cancers. In the majority of patients with cancer, cytotoxic chemotherapy is administered intravenously and in some instances by oral administration. Systemic administration of cytotoxic chemotherapy is well known to cause adverse effects, which can be severe and debilitating. Regional therapy with cytotoxic agents has the potential to reduce the extent of systemic exposure to the drug and reduce the risk of systemic adverse effects. Regional chemotherapy has been successfully employed in the treatment of certain solid tumors such as hepatocellular carcinoma. However, regional chemotherapy has not been commonly utilized for treatment of lung tumors. Inhaled cytotoxic chemotherapy has the potential to become an effective regional therapy for both primary lung cancer and metastases to the lung from other primary tumors. Aerosol administration of chemotherapy could potentially avoid some of the adverse effects seen with systemic therapy. In addition, some chemotherapeutic agents when administered as an aerosol are absorbed directly into the arterial circulation and have therapeutic effects at extrapulmonary sites. Aerosol administration of several different chemotherapeutic agents is currently under evaluation either in the preclinical setting or in early phase human trials. Some of these studies have shown that inhaled chemotherapy is feasible and effective in treating lung tumors. In this chapter, we review the published studies and ongoing trials on inhaled chemotherapy to better understand the current status of this field of cancer treatment.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"38 2","pages":"90-101"},"PeriodicalIF":2.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12061006/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143764082","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}