Increasing Access to Undesignated Asthma Medication in Illinois.

Asthma is common among the pediatric population. Exacerbations of this chronic condition can lead to emergency department visits and hospitalizations, resulting in time away from school. Children spend the majority of their day at school, where they may need access to quick relief medication to treat respiratory distress. Students' personal asthma medication is not always available in school. School nurses in Illinois collected data and undertook a quality improvement project to increase the number of schools in North Suburban Cook County with undesignated asthma medication. A toolkit was created and shared, helping to remediate barriers associated with obtaining undesignated asthma medication. With access to undesignated asthma medication, school nurses ensure students with asthma receive prompt treatment and coordination of care.

[Recommendations for Reducing the Environmental Impact of Inhalers in Portugal: Consensus Document]. / Recomendações para a Redução do Impacto Ambiental dos Inaladores em Portugal: Documento de Consenso.

This consensus document addresses the reduction of the environmental impact of inhalers in Portugal. It was prepared by the Portuguese Council for Health and the Environment and the societies representing the specialties that account for these drugs' largest volume of prescriptions, namely the Portuguese Society of Pulmonology, the Portuguese Society of Allergology and Clinical Immunology, the Portuguese Society of Pediatrics, the Portuguese Society of Internal Medicine, the Portuguese Association of General and Family Medicine and also a patient association, the Respira Association. The document acknowledges the significant impact of pressurized metered-dose inhalers on greenhouse gas emissions and highlights the need to transition to more sustainable alternatives. The carbon footprint of pressurized metered-dose inhalers and dry powder inhalers in Portugal was calculated, and the level of awareness among prescribing physicians on this topic was also estimated. Finally, recommendations were developed to accelerate the reduction of the ecological footprint of inhalers.

Este documento de consenso aborda a redução do impacto ambiental dos inaladores em Portugal. Foi elaborado pelo Conselho Português para a Saúde e Ambiente e pelas sociedades que representam as especialidades com maior volume de prescrição destes medicamentos, nomeadamente a Sociedade Portuguesa de Pneumologia, a Sociedade Portuguesa de Alergologia e Imunologia Clínica, a Sociedade Portuguesa de Pediatria, a Sociedade Portuguesa de Medicina Interna e a Associação Portuguesa de Medicina Geral e Familiar em conjunto com uma associação de doentes, a Associação Respira. Reconhece-se o impacto significativo dos inaladores pressurizados doseáveis nas emissões de gases com efeito de estufa e a necessidade de transição para alternativas mais sustentáveis. Calculou-se a pegada de carbono dos inaladores pressurizados doseáveis e dos inaladores de pó seco em Portugal e estimou-se o nível de literacia dos médicos prescritores relativamente a este tema. Finalmente, foram elaboradas recomendações com o objetivo de acelerar a redução da pegada ecológica dos inaladores.

The environmental burden of inhalation.

Inhalation systems, mostly metered dose inhalers (MDIs) and dry powder inhalers (DPIs), are currently submitted to a critical assessment for their carbon footprint (CF) and environmental impact. They are related to greenhouse gas (GHG) emissions and they produce waste of used devices with withheld drug residues and unused doses. However, with estimated contributions to anthropogenic GHG-emissions of 0.03% for MDIs and 0.0012% for DPIs globally, it may not be expected that mitigating the GHG emissions from inhalers will have a meaningful effect on the current climate change and global warming, notwithstanding that nationally these percentages may be somewhat higher, depending on the ratio of MDIs to DPIs and the total national CF. MDIs are particularly the preferred type of inhalers over DPIs in the USA and UK with ratios of 9: 1 and 7: 3 respectively. In such countries, a partial switch from MDIs to DPIs is to be recommended, providing that such a switch does not jeopardize the therapy. Using renewable energy only for the production and waste management of DPIs will make this type of inhaler almost climate neutral. A greater concern exists about inhaler waste, more particularly about the residual drug and unused doses in discarded devices. Inhalers contribute less than 0.02% to global plastic waste annually and most plastic inhalers end in the domestic waste bin and not as litter polluting the environment with plastic. However, they do contain retained drug and unused doses, whereas even full inhalers are disposed. Because globally most municipal waste (70%) ends up in dumps and landfills, leakage of the drugs into the soil and surface waters is a serious problem. It pollutes drinking water and endangers species and biodiversity. Therefore, a good collection system and an adequate waste management program for used inhalers seems to be the most meaningful measure to take for the environment, as this will stop inhalers and drugs from putting ecosystems at risk.

Effectiveness of an Aerosol Inhalation Monitor in an Ambulatory Primary Care Pharmacy Clinic.

Background: Poor inhaler technique can worsen respiratory disease. An Aerosol Inhalation Monitor (AIM) may provide insight into a patient's capability of utilizing inhaled medications. Objective: The purpose of this quality assessment was to determine if the addition of the Vitalograph AIM device by ambulatory care pharmacists within an outpatient primary care clinic improves patient's disease control through changes in pharmacotherapy. Methods: This was a retrospective, longitudinal, quality assessment review. Pharmacists met with patients for initial and follow-up appointments. A chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) or Asthma Control Test (ACT) and AIM assessment were performed and pharmacotherapy was subsequently adjusted. The primary endpoint was the change in initial to last recorded ACT and CAT score and was analyzed by Wilcoxon sign-rank test. Results: Twenty asthma and 17 COPD patients were included; 13 asthma and 13 COPD patients were included in the primary and secondary endpoint analysis. Initial median (interquartile range [IQR]) ACT score was 17 (14-23), first follow-up was 20 (18-24), and last recorded score was 22 (18-23). Initial median (IQR) CAT score was 17 (12-22), first follow-up score was 14 (6-20), and last recorded score was 11 (6-19). There was no statistical difference between initial CAT or ACT to first follow-up or last recorded CAT or ACT. Most patients continued their current inhaler regimen. Conclusions: This review demonstrates the positive effect pharmacists can have on respiratory disease management. The improvement in ACT and CAT scores suggests a positive, clinically significant outcome. Future research should evaluate pharmacist's effect on asthma and COPD readmission rates.

Comparisons between In-Check DIAL® and PF810® in evaluation and training inspiratory capacity for using dry powder inhalers.

BACKGROUND: Dry powder inhalers (DPIs) rely on both internal resistance and patients' inspiratory capacity for effective operation. Optimal inspiratory technique is crucial for DPI users. This study assessed the accuracy and repeatability of two available devices, PF810® and In-Check DIAL®, and analyzed their measurement errors and consistency in detecting inspiratory capacity. METHODS: The accuracy and repeatability of peak inspiratory flow (PIF) and forced inspiratory vital capacity (FIVC) against various internal resistances of the two devices were assessed using standard waveforms generated by a breathing simulator. The agreement of PIF measurements between the two devices in healthy volunteers and chronic obstructive pulmonary disease (COPD) patients was analyzed with the intraclass correlation coefficient and Bland-Altman graphical analysis. RESULTS: PF810® showed great accuracy and repeatability in measuring PIF, except for square waveforms at the lowest flow rate (20 L/min). In-Check DIAL® exhibited poor accuracy against high resistance levels. In scenarios with no resistance, In-Check DIAL® had significantly smaller measurement errors than PF810®, but larger errors against high resistance levels. The two devices showed excellent agreement (ICC > 0.80, P < 0.05), except for healthy volunteers against medium to high resistance (R3-R5) where the ICC was insignificant. Bland-Altman plots indicated small disagreements between the two devices for both healthy volunteers and COPD patients. CONCLUSIONS: In-Check DIAL® exhibited poor accuracy and larger measurement errors than PF810® when detecting PIFs against higher internal resistances. However, its good performance against lower internal resistances, along with its cost-effectiveness and convenience made it appropriate for primary care. PF810® showed good accuracy and repeatability and could detect additional parameters of inspiratory capacity beyond PIF, though required further studies to confirm its clinical benefits.

Inhalational Drug Devices: Revisiting the Linchpin of Asthma Management.

Asthma remains a prevalent condition among all age groups globally. First-line treatment requires the delivery of medications into the distal respiratory tract via inhalers. Using appropriate inhaler techniques is a significant challenge in achieving disease control. A variety of inhalers are available for treating asthma, and selecting the appropriate inhaler type for any given patient is crucial to achieving and maintaining symptomatic control. This review will discuss the anatomy and physiology behind drug delivery via inhalers, the types of inhalers currently available for use, nebulizers, and future directions in the delivery of inhaled medications for asthma.

Reshaping respiratory care: potential advances in inhaled pharmacotherapy in asthma.

INTRODUCTION: Asthma is a common disease with a global burden of 358 million patients. Despite improvements in pharmacological and non-pharmacological treatments, many patients still do not achieve complete asthma control. Therefore, innovative pharmacotherapy is important. AREAS COVERED: Following a semi-structured search in Pubmed, an overview of advances in inhaled asthma therapy is provided, looking at innovations in digital inhalers, eco-friendly inhalers and novel inhaled biologic therapies, antibiotics and vaccines, as well as other potential novel asthma therapy targets. EXPERT OPINION: Digital inhalers, sending reminders and monitoring inhalation technique electronically, can support medication adherence and improve asthma control. To reduce the global warming potential of traditional aerosols used in pressurized metered-dose inhalers (HFA-134a, HFA-227ea), greener alternatives are under development (HFA-152a, HFO-1234ze) that are expected to be available by 2025. Current pharmacological advances in asthma therapy are mainly achieved by novel biologicals (anti-IgE, anti-IL5, anti-IL4/13, and anti-TSLP) targeting specific severe asthma phenotypes. While injection is the usual administration route for biologics and vaccines used in asthma, inhalation is an option being explored, although several (mainly formulation) challenges need to be overcome. Other potential novel future inhaled asthma therapies include anti-IL-33/ST2 biologicals and JAK inhibitors, all still requiring more clinical evidence.

Highly Drug-Loaded Nanoaggregate Microparticles for Pulmonary Delivery of Cyclosporin A.

Introduction: Nanoparticles have the advantages of improving the solubility of poorly water-soluble drugs, facilitating the drug across biological barriers, and reducing macrophage phagocytosis in pulmonary drug delivery. However, nanoparticles have a small aerodynamic particle size, which makes it difficult to achieve optimal deposition when delivered directly to the lungs. Therefore, delivering nanoparticles to the lungs effectively has become a popular research topic. Methods: Nanoaggregate microparticles were used as a pulmonary drug delivery strategy for the improvement of the bioavailability of cyclosporine A (CsA). The nanoaggregate microparticles were prepared with polyvinyl pyrrolidone (PVP) as the excipient by combining the anti-solvent method and spray drying process. The physicochemical properties, aerodynamic properties, in vivo pharmacokinetics and inhalation toxicity of nanoaggregate microparticles were systematically evaluated. Results: The optimal nanoparticles exhibited mainly spherical shapes with the particle size and zeta potential of 180.52 nm and -19.8 mV. The nanoaggregate microparticles exhibited irregular shapes with the particle sizes of less than 1.6 µm and drug loading (DL) values higher than 70%. Formulation NM-2 as the optimal nanoaggregate microparticles was suitable for pulmonary drug delivery and probably deposited in the bronchiole and alveolar region, with FPF and MMAD values of 89.62% and 1.74 µm. In addition, inhaled NM-2 had C max and AUC0-∞ values approximately 1.7-fold and 1.8-fold higher than oral cyclosporine soft capsules (Neoral®). The inhalation toxicity study suggested that pulmonary delivery of NM-2 did not result in lung function damage, inflammatory responses, or tissue lesions. Conclusion: The novel nanoaggregate microparticles for pulmonary drug delivery could effectively enhance the relative bioavailability of CsA and had great potential for clinical application.

Current technological advancement in asthma care.

INTRODUCTION: Asthma is a common chronic respiratory disease affecting 262 million people globally, causing half a million deaths each year. Poor asthma outcomes are frequently due to non-adherence to medication, poor engagement with asthma services, and a lack of objective diagnostic tests. In recent years, technologies have been developed to improve diagnosis, monitoring, and care. AREAS COVERED: Technology has impacted asthma care with the potential to improve patient outcomes, reduce healthcare costs, and provide personalized management. We focus on current evidence on home diagnostics and monitoring, remote asthma reviews, and digital smart inhalers. PubMed, Ovid/Embase, Cochrane Library, Scopus and Google Scholar were searched in November 2023 with no limit by year of publication. EXPERT OPINION: Advanced diagnostic technologies have enabled early asthma detection and personalized treatment plans. Mobile applications and digital therapeutics empower patients to manage their condition and improve adherence to treatments. Telemedicine platforms and remote monitoring devices have the potential to streamline asthma care. AI algorithms can analyze patient data and predict exacerbations in proof-of-concept studies. Technology can potentially provide precision medicine to a wider patient group in the future, but further development is essential for implementation into routine care which in itself will be a major challenge.

A clinician's guide to single vs multiple inhaler therapy for COPD.

INTRODUCTION: In the management of chronic obstructive pulmonary disease (COPD), inhalation therapy plays a pivotal role. However, clinicians often face the dilemma of choosing between single and multiple inhaler therapies for their patients. This choice is critical because it can affect treatment efficacy, patient adherence, and overall disease management. AREAS COVERED: This article examines the advantages and factors to be taken into consideration when selecting between single and multiple inhaler therapies for COPD. EXPERT OPINION: Both single and multiple inhaler therapies must be considered in COPD management. While single inhaler therapy offers simplicity and convenience, multiple inhaler therapy provides greater flexibility and customization. Clinicians must carefully evaluate individual patient needs and preferences to determine the most appropriate inhaler therapy regimen. Through personalized treatment approaches and shared decision-making, clinicians can optimize COPD management and improve patient well-being. Nevertheless, further research is required to compare the effectiveness of single versus multiple inhaler strategies through rigorous clinical trials, free from industry bias, to determine the optimal inhaler strategy. Smart inhaler technology appears to have the potential to enhance adherence and personalized management, but the relative merits of smart inhalers in single inhaler regimens versus multiple inhaler regimens remain to be determined.

Small airways disease in chronic obstructive pulmonary disease.

INTRODUCTION: Small airway disease (SAD) represents a common and critical feature of Chronic Obstructive Pulmonary Disease (COPD). Introduced in the '60s, SAD has gradually gained increasing interest as assessment methodologies have improved. Chronic exposure to smoking and noxious particles or gases induces inflammation and remodeling, leading to airway obstruction and SAD, eventually resulting in complete airway loss. AREAS COVERED: A literature search up to June 2024 was performed in PubMed to identify articles on SAD and airway diseases mainly COPD, but also to the extent that it seemed relevant in the uncontrolled/severe asthma field, where SAD is better studied. We provide clinicians and translational scientists with a comprehensive analysis of the existing literature on SAD in COPD, concentrating on the underlying pathophysiological mechanisms, diagnostic techniques, and current pharmacological approaches targeting airflow obstruction in small airways. EXPERT OPINION: Small airways are the primary site for the onset and progression of airflow obstruction in patients with COPD, with significant clinical consequences associated with poor lung function, hyperinflation, and impaired quality of life. The early identification of individuals with subclinical SAD may allow us to prevent its further progress from airway loss and potential development of emphysema and choose the appropriate therapeutic approach.

Impact of Pharmacist-Led Intervention on Adherence to Inhalers, Inhalation Technique, and Disease Control Among Asthma/COPD Patients in a Resource Limited Center: An Interventional Study.

Background: Asthma and Chronic obstructive pulmonary disease (COPD) are chronic respiratory conditions characterized by airflow obstruction and respiratory symptoms. Adherence to prescribed inhaler therapy and correct inhalation technique are essential for effective disease management and optimal disease control. However, non-adherence and incorrect inhalation technique are common challenges faced by patients with asthma and COPD, leading to suboptimal treatment outcomes and increased healthcare burden. Purpose: To study the impact of a pharmacist-led intervention on inhaler adherence, inhalation technique, and disease control among patients with asthma and COPD. Patients and Methods: A pre-post interventional design assessed the effects of pharmacist-led intervention on inhaler adherence, inhalation techniques, and disease control in asthma and COPD patients at Dhulikhel Hospital in Nepal. Inclusion criteria: adult patient clinically diagnosed with asthma or COPD patients of all genders. The intervention comprised counseling patients with aids like videos, and informational leaflets. Impact was measured using checklist method for inhalation technique, the Test of Adherence to Inhaler (TAI) questionnaire for adherence to inhaler, and "Asthma Control Test (ACT)" or "COPD Assessment Test (CAT)" for disease control. Results: The pharmacist-led intervention significantly increased adherence to inhalers, evidenced by a notable rise in the proportion of patients with good adherence (P<0.001). Sporadic, deliberate, and unwitting noncompliance pattern also improved significantly after the intervention (P<0.001, P<0.001 and P=0.001). Inhalation technique exhibited substantial improvement after intervention (P<0.001). The analysis indicated significant moderate negative correlations between "TIA" and "CAT" [ρ=-0.31; P=0.01], and between "inhalation technique score" and "CAT score" [ρ=-0.31; P=0.01] suggesting that as adherence to inhaler usage and inhalation technique improve, CAT scores tend to decrease, indicating reduced disease impact on the patient. Conclusion: This study shows the potential efficacy of pharmacist-led intervention in enhancing adherence to inhaler, inhalation technique, and disease control in respiratory conditions such as asthma and COPD.

Improvement in Inhaler Techniques After Training and Counseling in Patients With Chronic Obstructive Pulmonary Disease or Asthma.

Background Chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma significantly impair quality of life and impose a substantial burden on healthcare systems. Proper inhalation technique is important for effective management of these diseases, yet remains poorly performed by many patients. This study evaluated the impact of structured counseling and training sessions on inhaler use among patients with COPD and asthma, aiming to enhance technique correctness and disease control. Methodology This cross-sectional study analyzed 150 patients with asthma and COPD who fulfilled the inclusion criteria for inhalation techniques. Patients were counseled regarding the proper seven-step inhalation technique for each inhaler type [metered-dose inhaler (MDI), MDI with spacer, and dry powder inhaler (DPI)] through practical demonstration at baseline visits. Correct use of inhalers was assessed by a predefined checklist for each inhaler device at the baseline visit and after three months. The correctness of the inhalation technique was evaluated by scoring each of the seven steps. The disease control assessment was done using the COPD assessment test (CAT) and asthma control test (ACT) at the baseline visit and after three months. Results In this study of 150 patients, there were 97 (64.7%) males and 53 (35.3%) females. In total, 67 (44.7%) were diagnosed with asthma and 83 (55.3%) with COPD. The mean age was 45.33 ± 12.62 years. Post-counseling improvements in inhaler technique were marked, with MDI users enhancing their technique score from an average of 4.4 to 6.1, MDI with spacer from 4.56 to 6.26, and DPI from 4.92 to 6.24 (p < 0.001 for all). Disease control also showed significant gains; CAT scores decreased for MDI users from 23.4 to 20.5, MDI with spacer from 23.92 to 20.96, and DPI from 24.89 to 21.96. Concurrently, ACT scores increased for MDI users from 16.4 to 18.0 (p = 0.002), MDI with spacer from 17.29 to 19.04, and DPI from 16.42 to 18.37 (p < 0.001 for both), reflecting substantive advances in managing COPD and asthma symptoms. Furthermore, patients with primary education exhibited a significant boost in technique mastery post-counseling (p < 0.001), underscoring the potential of well-crafted counseling to transcend educational barriers in promoting effective inhaler use. Conclusions Post-counseling, inhaler technique improved significantly across all types, with MDI with spacer users demonstrating the most progress. Technique scores increased notably (p < 0.001), and disease control scores for COPD and asthma, measured by CAT and ACT, also showed significant improvements (p < 0.001). Remarkably, primary education level participants exhibited substantial technique gains post-intervention, emphasizing the effectiveness of counseling irrespective of initial educational status in enhancing inhaler use and disease management.

Polyvinyl alcohol-based capsule shells manufactured by injection molding as ready-to-use moisture barriers for the development of delivery systems.

In this work, feasibility of injection molding was demonstrated for manufacturing capsule shells. 600 µm-thick prototypes were successfully molded with pharmaceutical-grade low-viscosity polyvinyl alcohols (PVAs), possibly added with a range of different fillers. They showed reproducible weight and thickness (CV < 2 and 5, respectively), compliant behavior upon piercing (holes diameter analogous to the reference), tunable release performance (immediate and pulsatile), and moisture protection capability. To assess the latter, an on-line method relying on near infrared spectroscopy measurements was set-up and validated. Based on the data collected and considering the versatility IM would provide for product shape/thickness/composition, PVA-based molded shells could help widening the portfolio of ready-to-use capsules, representing an interesting alternative to those commercially available. Indeed, these capsules could be filled with various formulations, even those with stability issues, and intended either for oral administration or for pulmonary delivery via single-dose dry powder inhalers.

A Review on Micro and Nanoengineering in Powder-Based Pulmonary Drug Delivery.

Pulmonary delivery of drugs has emerged as a promising approach for the treatment of both lung and systemic diseases. Compared to other drug delivery routes, inhalation offers numerous advantages including high targeting, fewer side effects, and a huge surface area for drug absorption. However, the deposition of drugs in the lungs can be limited by lung defence mechanisms such as mucociliary and macrophages' clearance. Among the delivery devices, dry powder inhalers represent the optimal choice due to their stability, ease of use, and absence of propellants. In the last decades, several bottom-up techniques have emerged over traditional milling to produce inhalable powders. Among these techniques, the most employed ones are spray drying, supercritical fluid technology, spray freeze-drying, and thin film freezing. Inhalable dry powders can be constituted by micronized drugs attached to a coarse carrier (e.g., lactose) or drugs embedded into a micro- or nanoparticle. Particulate-based formulations are commonly composed of polymeric micro- and nanoparticles, liposomes, solid lipid nanoparticles, dendrimers, nanocrystals, extracellular vesicles, and inorganic nanoparticles. Moreover, engineered formulations including large porous particles, swellable microparticles, nano-in-microparticles, and effervescent nanoparticles have been developed. Particle engineering has also a crucial role in tuning the physical-chemical properties of both carrier-based and carrier-free inhalable powders. This approach can increase powder flowability, deposition, and targeting by customising particle surface features.

Bronchodilator administration by pressurized inhaler during invasive mechanical ventilation in adults: A scoping review.

OBJECTIVE: To identify the administration characteristics and connection methods of bronchodilators by pressurized inhalers to the ventilatory circuit of patients under invasive mechanical ventilation. METHODS: A scope review was conducted following the PRISMA for Scoping Review, using the PubMed, Embase Elsevier, Cochrane Library, and Lilacs databases without language restrictions, up to July 2023. Eligible sources included reviews and consensuses (based on clinical studies), experimental and observational studies involving adult patients admitted to the intensive care unit and undergoing invasive mechanical ventilation, regardless of the underlying condition, who used bronchodilator drugs contained in pressurized inhalers. Information regarding inhalation technique, pressurized inhalers connection mode to the circuit, and patient care were collected by 2 researchers independently, with discrepancies resolved by a third reviewer. Studies involving bronchodilators combined with other pharmacological classes in the same device, as well as reviews containing preclinical studies, were excluded. RESULTS: In total, 23 publications were included, comprising 19 clinical trials and 4 non-randomized experimental studies. Salbutamol (albuterol) was the bronchodilator of study in the majority of the articles (n=18), and the spacer device was the most commonly used to connect the pressurized inhaler to the circuit (n=15), followed by an in-line adapter (n=3), and a direct-acting device without chamber (n=3). Concerning the pressurized inhaler placement in the circuit, 18 studies positioned it in the inspiratory limb, and 19 studies synchronized the jet actuation with the start of the inspiratory phase. Agitation of the pressurized inhaler before each actuation, waiting time between actuations, airway suction before administration, and semi-recumbent patient positioning were the most commonly described measures across the studies. CONCLUSIONS: This review provided insights into the aspects related to inhalation technique in mechanically ventilated patients, as well as the most prevalent findings and the existing gaps in knowledge regarding bronchodilator administration in this context. The evidence indicates the need for further research on this subject.

Developing Dry Powder Inhaler Formulations.

This section aims to provide a concise and contemporary technical perspective and reference resource covering dry powder inhaler (DPI) formulations. While DPI products are currently the leading inhaled products in terms of sales value, a number of confounding perspectives are presented to illustrate why they are considered surprisingly, and often frustratingly, poorly understood on a fundamental scientific level, and most challenging to design from first principles. At the core of this issue is the immense complexity of fine cohesive powder systems. This review emphasizes that the difficulty of successful DPI product development should not be underestimated and is best achieved with a well-coordinated team who respect the challenges and who work in parallel on device and formulation and with an appreciation of the handling environment faced by the patient. The general different DPI formulation types, which have evolved to address the challenges of aerosolizing fine cohesive drug-containing particles to create consistent and effective DPI products, are described. This section reviews the range of particle engineering processes that may produce micron-sized drug-containing particles and their subsequent assembly as either carrier-based or carrier-free compositions. The creation of such formulations is then discussed in the context of the material, bulk, interfacial and ultimately drug-delivery properties that are considered to affect formulation performance. A brief conclusion then considers the future DPI product choices, notably the issue of technology versus affordability in the evolving inhaler market.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines Reviewed.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report is an essential resource for all clinicians who strive to provide optimal care to patients with chronic obstructive lung disease (COPD). The annual report of GOLD makes few revisions and updates besides including data from the preceding year. At an interval, GOLD comes up with a significant modification in its guidelines, which is generally a major overhaul of the pre-existing guidelines. According to the latest 2023 updates, published in November 2022, there have been significant advancements made in the field of COPD. These include the development of more precise definitions for COPD and its exacerbations, the introduction of a new set of parameters to measure exacerbation severity, and updating the COPD assessment tool. Additionally, revisions have been made to the initial and follow-up treatment guidelines. The report also simplifies the treatment algorithm and sheds light on new findings that suggest the use of pharmacological triple therapy can reduce mortality rates. Furthermore, the report includes discussions on inhaler device selection and adherence to COPD medications. These improvements demonstrate a continued effort to enhance COPD treatment and management. Although there are some areas that could benefit from more detailed guidance and explanation, such as the proper utilization of blood eosinophil counts for treatment decisions, and the establishment of treatment protocols post-hospitalization, the latest modifications to the GOLD recommendations will undoubtedly aid healthcare providers in addressing any gaps in patient care. We aim to highlight key changes in the GOLD 2023 report and present a viewpoint about their potential implications in a real-world clinical scenario.

Development of a self-microemulsifying drug delivery system to deliver delamanid via a pressurized metered dose inhaler for treatment of multi-drug resistant pulmonary tuberculosis.

Tuberculosis (TB) is a serious health issue that contributes to millions of deaths throughout the world and increases the threat of serious pulmonary infections in patients with respiratory illness. Delamanid is a novel drug approved in 2014 to deal with multi-drug resistant TB (MDR-TB). Despite its high efficiency in TB treatment, delamanid poses delivery challenges due to poor water solubility leading to inadequate absorption upon oral administration. This study involves the development of novel formulation-based pressurized metered dose inhalers (pMDIs) containing self-microemulsifying mixtures of delamanid for efficient delivery to the lungs. To identify the appropriate self-microemulsifying formulations, ternary diagrams were plotted using different combinations of surfactant to co-surfactant ratios (1:1, 2:1, and 3:1). The combinations used Cremophor RH40, Poly Ethylene Glycol 400 (PEG 400), and peppermint oil, and those that showed the maximum microemulsion region and rapid and stable emulsification were selected for further characterization. The diluted self-microemulsifying mixtures underwent evaluation of dose uniformity, droplet size, zeta potential, and transmission electron microscopy. The selected formulations exhibited uniform delivery of the dose throughout the canister life, along with droplet sizes and zeta potentials that ranged from 24.74 to 88.99 nm and - 19.27 to - 10.00 mV, respectively. The aerosol performance of each self-microemulsifying drug delivery system (SMEDDS)-pMDI was assessed using the Next Generation Impactor, which indicated their capability to deliver the drug to the deeper areas of the lungs. In vitro cytotoxicity testing on A549 and NCI-H358 cells revealed no significant signs of toxicity up to a concentration of 1.56 µg/mL. The antimycobacterial activity of the formulations was evaluated against Mycobacterium bovis using flow cytometry analysis, which showed complete inhibition by day 5 with a minimum bactericidal concentration of 0.313 µg/mL. Moreover, the cellular uptake studies showed efficient delivery of the formulations inside macrophage cells, which indicated the potential for intracellular antimycobacterial activity. These findings demonstrated the potential of the Delamanid-SMEDDS-pMDI for efficient pulmonary delivery of delamanid to improve its effectiveness in the treatment of multi-drug resistant pulmonary TB.