Individualized aerosol medicine: Integrating device into the patient.

Pulmonary drug delivery is complex due to several challenges including disease-, patient-, and clinicians-related factors. Although many inhaled medications are available in aerosol medicine, delivering aerosolized medications to patients requires effective disease management. There is a large gap in the knowledge of clinicians who select and provide instructions for the correct use of aerosol devices. Since improper device selection, incorrect inhaler technique, and poor patient adherence to prescribed medications may result in inadequate disease control, individualized aerosol medicine is essential for effective disease management and control. The components of individualized aerosol medicine include: (1) Selecting the right device, (2) Selecting the right interface, (3) Educating the patient effectively, and (4) Increasing patient adherence to therapy. This paper reviews each of these components and provides recommendations to integrate the device and interface into the patient for better clinical outcomes.

Digitally monitored inhaled therapy: a 'smart' way to manage severe asthma?

INTRODUCTION: One of the fundamental challenges of managing patients with severe asthma is treatment adherence, particularly with inhaled corticosteroids. Adherence is difficult to measure objectively and poor adherence is associated with worse outcomes. In this study, assess the ability of a 'smart' inhaler to record adherence in severe asthma patients and measure the impact of this on asthma control. METHODS: Consecutive consenting patients meeting criteria for biologics had their existing high-dose ICS/LABA//LAMA combination inhaler/s switched to mometasone/indacaterol/glycopyrronium (114/46/136). Routine clinical data, including blood eosinophils, FeNO, and ACQ-6 scores were collected at baseline and at 4 wk. Adherence was then checked on the Propeller Health app, and good adherence was defined as >80% of prescribed usage. Participants were then followed-up at 12 months to record the proportion of patients who were initiated on biologics. RESULTS: 77 patients (mean [SD] age = 50.4 [15.7] years, 67.5% female [n = 52]) participated. 71 participants were able to use the device and 65% (n = 46) of these attained good asthma control and were not initiated on biologics at 12-month follow-up. Both groups demonstrated a significant reduction in ACQ6 score at follow-up (2.81 vs. 1.92, p < 0.001 and 3.05 vs. 2.60, p < 0.001, respectively), but there was no statistically significant difference in improvement between groups. Patients with optimal adherence also demonstrated a significant reduction in median FeNO at follow-up (47 ppb vs. 40 ppb, p = 0.003). CONCLUSIONS: In severe asthma patients, 'smart' inhalers may represent an effective management tool to improve adherence and asthma control, therefore avoiding the need for patients to commence biological therapies.

Efficacy and safety of Once-Daily Vilanterol/Fluticasone furoate MDI in persistent asthma: Phase 3 OD-INHALE Study.

INTRODUCTION: Once-daily inhalers have been shown to improve adherence leading to lesser discontinuation compared to twice- or thrice-daily inhalers in management of asthma. Combination of Vilanterol and Fluticasone Furoate (VI/FF) is approved for management of asthma and COPD and is available as a dry powder inhaler. Pressurized-Metered Dose Inhalers (pMDIs) offer ease-of-use and therapy alternatives for patients with low inspiratory flow. This study assessed the efficacy and safety of a new once-daily pMDI containing VI/FF in individuals diagnosed with persistent asthma. METHODS: This phase 3, double-blind, randomized controlled study assessed the non-inferiority of VI/FF (12.5 mcg/50 mcg & 12.5 mcg/100 mcg; 2 puffs once-daily) over Formoterol Fumarate and Fluticasone Propionate (FOR/FP, 6 mcg/125 mcg & 6 mcg/250 mcg; 2 puffs twice-daily) in patients with persistent asthma. Primary outcome was change from baseline in trough FEV1 at the end of study (12 weeks). Adverse events and number of exacerbations were used to evaluate safety. RESULTS: A total of 330 patients were randomized into VI/FF (165) and FOR/FP (165). Trough FEV1 significantly improved in both the groups at week 12, with a mean difference (VI/FF minus FOR/FP) being 54.75 mL (95% CI, 8.42-101.08 mL, p = 0.02). The low dose VI/FF had similar efficacy to that of low dose FOR/FP and high dose VI/FF had similar efficacy to high dose FOR/FP. No serious adverse events were reported during the study. CONCLUSION: Once daily VI/FF pMDI was non-inferior to twice daily FOR/FP pMDI in patients with persistent asthma.

Promoting knowledge of metered dose inhaler (MDI) usage among pharmacy professional students through a mobile app.

INTRODUCTION: Efficient asthma management necessitates optimal usage of metered-dose inhalers (MDIs). As future health professionals, pharmacy students are pivotal in disseminating accurate methodologies for MDI usage. Despite having hands-on experience, there is room to enhance their comprehension, highlighting the need for prompt patient educational interventions. OBJECTIVE: This study aims to evaluate the effectiveness of a mobile app-assisted educational method in improving pharmacy students' understanding of MDI usage. METHODS: A pre-experimental study was conducted from March to August 2021 with 45 participants enrolled in the Pharmacist Professional Study Program at the Faculty of Medicine and Health Sciences, Universitas Muhammadiyah Yogyakarta. Using a one-group pretest-post-test design, the study measured the app's impact on students' knowledge and MDI usage skills. RESULTS: The intervention significantly improved students' scores on a 9-step MDI usage checklist, with increases ranging from 0.10 to 0.50 across verbal and motor components. A Mann-Whitney U test validated these findings, showing a statistically significant p-value of 0.001. CONCLUSION: The mobile app-assisted educational approach substantially enhanced pharmacy students' proficiency in MDI use. The significant rise in mean scores for the 9-step checklist, along with the notable p-value, supports the effectiveness of this intervention in healthcare education.

Application of different counseling strategies for better adult asthma control.

OBJECTIVE: We aimed to compare the effectiveness of three distinct counseling methods to determine the most effective approach. METHODS: In this prospective cohort study with a two-month follow-up, A group of non-smoking adults, aged 19-60 years, were randomly collected at outpatients clinic with prior asthma diagnosis, based on the forced expiratory volume in one seconds to forced vital capacity ratio (FEV1/FVC) and the guidelines outlined by the Global Initiative for Asthma (GINA), At the baseline assessment, all patients, underwent FEV1/FVC measurements, asthma symptom evaluations using Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), and GINA symptoms control assessment questionnaire, and assessment of pressurized metered-dose inhaler (pMDI) usage. The patients were divided into three groups, each assigned a distinct counseling strategy: traditional verbal counseling, advanced counseling utilizing the Asthma smartphone-application, and a combination of advanced-verbal counseling. We conducted a two-month monitoring period for all three groups. RESULTS: Significant differences (p < .001) were observed among the three counseling groups in ACT, FEV1/FVC ratio, and GINA symptoms control assessment scores from the first month to the second month visit. Regarding ACQ, the study unveiled a noteworthy disparity in ACQ scores during the second week, with a significant difference (p = .025) observed between the verbal and advanced-verbal counseling groups. Similarly, a significant difference (p = .016) was noted between the advanced counseling group and the advanced-verbal counseling groups. CONCLUSION: The study findings indicate that the combining advanced-verbal counseling by incorporating the Asthma smartphone-application alongside traditional verbal counseling is a more effective approach for improving asthma control in adults.

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.

Inhaler use technique course: an effective postgraduate training solution for pharmacists to enhance therapeutic outcomes as part of patient education.

BACKGROUND: Patients with asthma and chronic obstructive pulmonary disease could benefit from education on using inhalers provided by pharmacists. However, pharmacists may have limited competencies, indicating the necessity to implement appropriate postgraduate courses. The study aimed to evaluate an inhaler use course for pharmacists, including its impact on participants' knowledge and satisfaction. METHODS: The study involved 261 pharmacists from community pharmacies and was conducted between September 2019 and March 2021. A pre-post analysis of their knowledge of the topic was applied. Additionally, at the beginning of the course, participants were asked about their educational needs, and at the end, they completed a satisfaction survey. The preferred learning formats indicated by participants were interactive workshops and lectures. RESULTS: As a result of the course, both their actual and self-assessed level of knowledge significantly increased. The percentage of correct answers in the test before the training was 24.4%, while after, it was 84.3% (p < 0.0001). Before the course, their average self-assessed level of knowledge was 52.0%, and after the training, it increased to 90.0% (p < 0.0001). Almost all respondents stated that the course met their expectations. They estimated their satisfaction at 94.0% and the usefulness of the provided information at 98.0%. CONCLUSIONS: Improved preparation of pharmacists resulting from their participation in the course can contribute to providing more professional advice to patients, thereby positively influencing the pharmaceutical care process in community pharmacies.

Overcoming the Low-Stability Bottleneck in the Clinical Translation of Liposomal Pressurized Metered-Dose Inhalers: A Shell Stabilization Strategy Inspired by Biomineralization.

Currently, several types of inhalable liposomes have been developed. Among them, liposomal pressurized metered-dose inhalers (pMDIs) have gained much attention due to their cost-effectiveness, patient compliance, and accurate dosages. However, the clinical application of liposomal pMDIs has been hindered by the low stability, i.e., the tendency of the aggregation of the liposome lipid bilayer in hydrophobic propellant medium and brittleness under high mechanical forces. Biomineralization is an evolutionary mechanism that organisms use to resist harsh external environments in nature, providing mechanical support and protection effects. Inspired by such a concept, this paper proposes a shell stabilization strategy (SSS) to solve the problem of the low stability of liposomal pMDIs. Depending on the shell material used, the SSS can be classified into biomineralization (biomineralized using calcium, silicon, manganese, titanium, gadolinium, etc.) biomineralization-like (composite with protein), and layer-by-layer (LbL) assembly (multiple shells structured with diverse materials). This work evaluated the potential of this strategy by reviewing studies on the formation of shells deposited on liposomes or similar structures. It also covered useful synthesis strategies and active molecules/functional groups for modification. We aimed to put forward new insights to promote the stability of liposomal pMDIs and shed some light on the clinical translation of relevant products.

[Educational interventions in childhood asthma: A systematic review]. / Intervenciones educativas en asma infantil: Una revisión sistemática.

OBJECTIVE: To analyze educational interventions in pediatric asthmatic patients to achieve an adequate inhalation technique and improve their self-management. DESIGN: Systematic review based on the PRISMA recommendations. DATA SOURCES: Pubmed, Scopus, Cuiden, Web of Science and Google Scholar databases were reviewed. STUDY SELECTION: Sixteen articles published between 2014 and 2021 were included, with access to full text, languages: English, French and Spanish and pediatric population: 0-18 years. DATA EXTRACTION: Two thousand three hundred and thirteen children were participated. The variables analyzed were: level of care, type of intervention, correct performance of the inhalation technique, follow-up of the technique, delivery of written recommendations, professional-educator category, variables related to respiratory pathology, school absenteeism, quality of life and economic costs. RESULTS: The health care level was primary, hospital and community care, where specialist doctors, nurses and pharmacists stood out as educators. The most prevalent educational interventions are on-site demonstration and delivery of recommendations or multimedia interventions. Several articles report that asthma education is not carried out correctly, others state that their technique improves after the intervention, but most of them highlight the importance of periodic review of the technique. CONCLUSIONS: The authors report improvement in the inhalation technique in all of them, as well as greater self-management of the disease and adherence to treatment. It is necessary to intensify the education of patients in the correct handling of the devices, and the follow-up and subsequent review to optimize the control of the disease.

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.

Quantifying Agglomerate-to-Wall Impaction in Dry Powder Inhalers.

PURPOSE: The probability of agglomerate-to-wall collision was quantified using a unique image processing technique applied to high-speed microscopic images. The study aimed to investigate the effects of flow rate and particle size on the percentage of colliding agglomerates detected within an in-house powder dispersion device. METHOD: The device consists of a swirl chamber and two tangential inlets in various configurations, designed to emulate the geometric features of commercial devices such as the Aerolizer® and Osmohaler®. The test cases were conducted with constant flow rates of 30 SLPM and 60 SLPM. Four powder samples were tested, including carrier Respitose® SV010 (median volume diameter 104 µm, span 1.7) and mannitol of three constituent primary particle sizes (3 µm, 5 µm and 7 µm; span 1.6 - 1.9). RESULTS: At the lower flow rate of 30 SLPM, collision frequencies were significantly different between powders of different constituent particle sizes, but the effects of powder properties diminished on increasing the flow rate to 60 SLPM. At the higher flow rate, all powders experienced a significant increase in the proportion of colliding particles. CONCLUSION: Analysis of collision events showed that the probability of collision for each agglomerate increased with agglomerate diameter and velocity. Experimental data of agglomerate-to-wall collision were utilised to develop a logistic regression model that can accurately predict collisions with various powders and flow rates.

In vitro Dissolution Testing of Rifampicin Powder Formulations For Prediction of Plasma Concentration-Time Profiles After Inhaled Delivery.

PURPOSE: The purpose of this study was to evaluate the in vitro lung dissolution of amorphous and crystalline powder formulations of rifampicin in polyethylene oxide (PEO) and 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), and to predict the in vivo plasma concentration-time profiles using the in vitro data. METHODS: The in vitro dissolution and permeation profiles of respirable rifampicin particles were studied using a custom-made dissolution apparatus. Data from the in vitro dissolution test were used to estimate the parameters to be used as the input for the simulation of in vivo plasma concentration-time profiles using STELLA® software. For prediction of in vivo profiles, a one-compartment model either with a first order elimination or with a Michaelis-Menten kinetics-based elimination was used. RESULTS: Compared to the crystalline formulation, the amorphous formulation showed rapid in vitro dissolution suggesting their possible faster in vivo absorption and higher plasma concentrations of rifampicin following lung delivery. However, the simulations suggested that both powder formulations would result in similar plasma-concentration time profiles of rifampicin. CONCLUSIONS: Use of an in vitro dissolution test coupled with a simulation model for prediction of plasma-concentration time profiles of an inhaled drug was demonstrated in this work. These models can also be used in the design of inhaled formulations by controlling their release and dissolution properties to achieve desired lung retention or systemic absorption following delivery to the lungs.

Appropriate inhaler use in children with asthma: barriers and opportunities through the lens of the socio-ecological model.

Objective: Proper use of inhaled medications is essential for management of asthma, as inhaled therapies are recommended as first-line for both prevention and treatment of asthma symptoms. Optimizing adherence requires identifying and understanding multiple layers of systemic complexity to obtaining and using these therapies and offering specific solutions to address these barriers. Bronfenbrenner's socio-ecological model provides a framework for examining multilevel systems - both internal and external - that contribute to the management of childhood asthma. The four levels in this model consist of factors related to the individual, interpersonal relationships, organizational entities, and societal structures and rules. This narrative review identifies influences and factors related to asthma inhaler adherence by each level and offers evidence-based solutions to each obstacle.Data Sources: We conducted PubMed searches to identify relevant articles for barriers and solutions impacting asthma control at each level of the socio-ecological model.Study Selection: Common barriers to asthma control at each model level were identified. Pertinent studies for each barrier were identified and reviewed by the writing group for inclusion into the narrative review.Results: For each level of the socio-ecological model, three primary issues were identified based on the literature review. Approaches for addressing each issue in an evidence-based, systematic fashion are presented.Conclusion: Understanding the obstacles and potential interventions to achieve proper use of inhaled medications is a critical step necessary to develop and implement systematic solutions aimed at improving asthma control and morbidity for the more than 6 million affected children in the United States.

Breath-actuated INhalation TheRapy: survey of phySicians' PErCepTion (INTROSPECT) in Nepal.

OBJECTIVE: Breath-actuated inhalers (BAIs) are gaining attention in the management of obstructive airway diseases (OADs). In Nepal, a BAI containing fluticasone propionate/salmeterol (FPS) has been available for a year. This survey is aimed at determining the perception and experience of physicians in Nepal concerning BAIs. METHODS: A cross-sectional, questionnaire-based survey was conducted. A total of 141 physicians participated and filled the survey. RESULTS: Most physicians felt that the right device should be easy to teach, learn and remember. They considered coordination and multiple steps as the primary challenges with pressurized metered-dose inhalers and dry powder inhalers, respectively. Most of them agreed that BAIs could address these challenges. BAIs were not only preferred by most of the physicians for asthma and chronic obstructive pulmonary disease but were also the preferred choice in newly diagnosed patients. Physicians believed that if current patients were shifted to BAIs, it could improve inhalation technique (88%) and compliance/adherence (81%). Almost all of them (92-97%) agreed that teaching the breathing technique and the cleaning process was easier and faster in BAIs. BAIs were considered easy and simple to use. Also, BAI's dose-counter helps patients to increase adherence to inhalation therapy. CONCLUSIONS: In this INTROSPECT survey, physicians in Nepal believed that BAIs could address the key challenges faced with using pMDIs and DPIs in asthma and COPD patients.

Estimated cost-savings from optimizing use of inhaled medications for inpatients with obstructive lung disease.

CONCLUSIONS: Models representing transitions from all-nebulized to nebulizer-plus-MDI respiratory medications resulted in cost savings, largely from the reduction of labor cost of nebulizer administration with nebs-only treatment. Therefore, transitioning from nebs to MDIs can lead to cost savings and could allow greater opportunities for inhaler education.

Corrigendum: Applications of exhaled breath condensate analysis for drug monitoring and bioequivalence study of inhaled drugs.

[This corrects the article DOI: 10.18433/jpps33121.].

Impact of Asthma Inhalers on Global Climate: A Systematic Review of Their Carbon Footprint and Clinical Outcomes in Spain.

BACKGROUND: Pressurized metered-dose inhalers (pMDIs) exert an environmental impact resulting from CO2 emissions. Therapeutic alternatives with less environmental impact are widely used. Nevertheless, the choice of device and appropriate therapy should meet the clinical needs and the characteristics of the patient. OBJECTIVE: The primary objective was to estimate the impact of pMDIs prescribed for any indication on annual CO2 emissions in Spain.The secondary objective was to evaluate the potential impact of switching pMDIs to dry-powder inhalers (DPIs) in patients with asthma. METHODS: A systematic review of the evidence published during 2010-2021 was carried out. Average annual CO2 emissions of DPIs and pMDIs were calculated in 2 scenarios: the current situation and a hypothetical situation involving a switch from all pMDIs to DPIs. The impact of the switch on clinical outcomes was also evaluated. RESULTS: The total value of CO2-eq/year due to DPIs and pMDIs accounted for 0.0056% and 0.0909%, respectively, of total emissions in Spain. In the event of switching pMDIs to DPIs, except those used for rescue medication, the percentages were 0.0076% and 0.0579%. The evaluation of efficacy, handling, satisfaction, safety, and use of health care resources was not conclusive. CONCLUSIONS: Current CO2 emissions by pMDIs account for a small percentage of the total CO2 footprint in Spain. Nevertheless, there is a need for research into new and more sustainable devices. Suitability and patient clinical criteria such as age and inspiratory flow should be prioritized when prescribing an inhaler.

Interprofessional peer-assisted learning for pharmacy and physical therapy students using inhalers and inhalation devices.

BACKGROUND: Peer-assisted learning (PAL) is exchanging knowledge between learners often from similar professional levels. Limited evidence exists on the effectiveness of PAL between different healthcare professions. The purpose of this study is to evaluate the knowledge, confidence, and perception of students engaged in an interprofessional PAL activity with pharmacy students instructing physical therapy students on the proper technique, cleaning/storage and therapeutic knowledge on inhaler devices for treatment of pulmonary conditions. METHODS: Pharmacy and physical therapy students completed a survey before and immediately after the PAL activity. As instructors, pharmacy students rated their experience with inhalers, their confidence if they were to assist clients on the use of inhaler devices and confidence in teaching peers. Physical therapy students completed surveys on inhaler knowledge with 10 scenario-based multiple-choice questions, and their confidence if they were to assist clients with inhaler devices. The knowledge questions were grouped into three categories: storage and cleaning of inhalers (3 questions), technique of using inhalers (4 questions), and therapeutic knowledge of drugs given by inhalation (3 questions). RESULTS: 102 physical therapy and 84 pharmacy students completed the activity and surveys. For the physical therapy students, the mean improvement of the total score for knowledge-based questions was 3.6 ± 1.8 (p < 0.001). The question with the fewest number of correct answers (13%) before the PAL activity had the highest number of correct answers post-activity (95%). Prior to the activity, no physical therapy students felt certain/very certain about their knowledge on inhalers, yet after PAL activity this proportion increased to 35%. The percent of pharmacy students reporting their confidence as "certain" and "very certain" in teaching peers increased from 46% before the activity to 90% afterwards. Pharmacy students rated the monitoring and follow-up of inhaler devices as the lowest expectation for physical therapists to play a role. Steps taken to prepare for this PAL activity were also discussed. CONCLUSIONS: Interprofessional PAL can increase knowledge and confidence of healthcare students reciprocally learning and teaching in joint activities. Allowing such interactions facilitate students to build interprofessional relationships during their training, which can increase communication and collaboration to foster an appreciation for each other's roles in clinical practice.

Cepharanthine Dry Powder Inhaler for the Treatment of Acute Lung Injury.

Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) induces a severe cytokine storm that may cause acute lung injury/acute respiratory distress syndrome (ALI/ARDS) with high clinical morbidity and mortality in infected individuals. Cepharanthine (CEP) is a bisbenzylisoquinoline alkaloid isolated and extracted from Stephania cepharantha Hayata. It exhibits various pharmacological effects, including antioxidant, anti-inflammatory, immunomodulatory, anti-tumor, and antiviral activities. The low oral bioavailability of CEP can be attributed to its poor water solubility. In this study, we utilized the freeze-drying method to prepare dry powder inhalers (DPI) for the treatment of acute lung injury (ALI) in rats via pulmonary administration. According to the powder properties study, the aerodynamic median diameter (Da) of the DPIs was 3.2 µm, and the in vitro lung deposition rate was 30.26; thus, meeting the Chinese Pharmacopoeia standard for pulmonary inhalation administration. We established an ALI rat model by intratracheal injection of hydrochloric acid (1.2 mL/kg, pH = 1.25). At 1 h after the model's establishment, CEP dry powder inhalers (CEP DPIs) (30 mg/kg) were sprayed into the lungs of rats with ALI via the trachea. Compared with the model group, the treatment group exhibited a reduced pulmonary edema and hemorrhage, and significantly reduced content of inflammatory factors (TNF-α, IL-6 and total protein) in their lungs (p < 0.01), indicating that the main mechanism of CEP underlying the treatment of ALI is anti-inflammation. Overall, the dry powder inhaler can deliver the drug directly to the site of the disease, increasing the intrapulmonary utilization of CEP and improving its efficacy, making it a promising inhalable formulation for the treatment of ALI.

Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).

Although nasal inhalation products are becoming more and more important for the delivery of medicines, characterization of these products for quality control and assessment of bioequivalence is complicated. Most of the problems encountered are associated with the assessment of aerodynamic droplet/particle size distribution (APSD). The droplets produced by the various nasal devices are large, and for suspension products, individual droplets may contain multiple drug particles or none at all. Assessment of suspension products is further complicated by the presence of solid excipient particles. These complications make it imperative that the limitations of the instruments used for characterization as well as the underlying assumptions that govern the interpretation of data produced by these instruments are understood. In this paper, we describe various methodologies used to assess APSD for nasal inhalation products and discuss proper use, limitations, and new methodologies on the horizon.