The impact of patients' real-life environmental temperature and humidity use conditions of tiotropium dry powder inhaler on its aerosol emission characteristics

Powder flowability is one of the most important properties affecting the filling and delivering processes of dry powder inhalations. When the powder is exposed to different environmental (temperature, relative humidity (RH)) conditions, the interaction between particulates would influence the flowability of powders. Blends of 83% coarse lactose (D50=126μm) and 17% fine lactose (D50= 7μm) were prepared at three different mixing environments and the effects of temperature and humidity on powder flowability were investigated. Results indicated that mixing under relatively higher temperature and lower RH environmental conditions improved the flowability of lactose blends.

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Dose uniformity of budesonide Easyhaler® under simulated real-life conditions and with low inspiration flow rates

Chronic Respiratory Disease ◽

10.1177/1479972317745733 ◽

2017 ◽

Vol 15 (3) ◽

pp. 265-271 ◽

Cited By ~ 3

Author(s):

Jussi Haikarainen ◽

Paula Rytilä ◽

Sirkku Roos ◽

Sirpa Metsärinne ◽

Anita Happonen

Keyword(s):

High Temperature ◽

Relative Humidity ◽

Real Life ◽

Dry Powder Inhaler ◽

Dose Delivery ◽

Flow Rates ◽

Life Conditions ◽

Dose Uniformity ◽

Temperature And Humidity ◽

Delivered Dose

Budesonide Easyhaler® multidose dry powder inhaler is approved for the treatment of asthma. Objectives were to determine the delivered dose (DD) uniformity of budesonide Easyhaler® in simulated real-world conditions and with different inspiration flow rates (IFRs). Three dose delivery studies were performed using 100, 200, and 400 µg/dose strengths of budesonide. Dose uniformity was assessed during in-use periods of 4–6 months after exposure to high temperature (30°C) and humidity (60% relative humidity) and after dropping and vibration testing. The influence of various IFRs (31, 43, and 54 L/min) on the DD was also investigated. Acceptable dose uniformity was declared when mean DD were within 80–120% of expected dose; all data reported descriptively. DD was constant (range: 93–109% of expected dose) at all in-use periods and after exposure to high temperature and humidity for a duration of up to 6 months. DD post-dropping and -vibration were unaffected (range 98–105% of expected dose). Similarly, DD was constant and within 10% of expected dose across all IFRs. Results indicate that budesonide Easyhaler® delivers consistently accurate doses in various real-life conditions. Budesonide Easyhaler® can be expected to consistently deliver a uniform dose and improve asthma control regardless of high temperature and humidity or varying IFR.

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Life-Cycle Assessment of the Breezhaler® Breath-Actuated Dry Powder Inhaler

Sustainability ◽

10.3390/su13126657 ◽

2021 ◽

Vol 13 (12) ◽

pp. 6657

Author(s):

Brett Fulford ◽

Karen Mezzi ◽

Andy Whiting ◽

Simon Aumônier

Keyword(s):

Life Cycle Assessment ◽

Life Cycle ◽

Environmental Impact ◽

Raw Materials ◽

Dry Powder Inhaler ◽

Resource Depletion ◽

Life Cycle Stage ◽

Low Carbon ◽

Dry Powder ◽

The Impact

The Breezhaler® dry powder inhaler (DPI) has a low carbon footprint compared with other inhalation therapies, consistent with the literature on other DPIs. This life-cycle assessment was conducted in France, Germany, the UK, and Japan using a “cradle-to-grave” technique to evaluate six environmental impact categories (global warming potential; acidification; ozone depletion; use of resource, minerals, and metals; eco-toxicity; and freshwater use) associated with the use of the Breezhaler®. Three variants of the Breezhaler® (30-day packs with and without the digital companion and a 90-day pack without the digital companion) were evaluated to identify major hotspots in the device life-cycle and to provide realistic solutions to reduce the environmental impact. Although no single life-cycle stage dominated the climate change impact of the 30-day device with the digital companion, the inhaler’s raw materials and packaging contributed to 96% of the resource depletion impact for the 30-day device without the digital companion. For the 90-day device without the digital companion, packaging contributed 42–62% of the impact across all categories. Overall, the Breezhaler® inhaler with the 90-day pack had the lowest environmental impact. The environmental impact of the device did not vary significantly among the considered markets. Further studies are needed to assess the impact of active pharmaceutical ingredients and improvement in clinical outcomes on the environment.

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The Global Usability Score Short-Form for the simplified assessment of dry powder inhalers (DPIs) usability

Multidisciplinary Respiratory Medicine ◽

10.4081/mrm.2020.659 ◽

2020 ◽

Vol 15 ◽

Author(s):

Massimiliano Povero ◽

Paola Turco ◽

Luca Bonadiman ◽

Roberto W. Dal Negro

Keyword(s):

Clinical Practice ◽

Short Form ◽

Objective Assessment ◽

Indirect Comparison ◽

Real Life ◽

Dry Powder Inhaler ◽

High Specificity ◽

Lasso Regression ◽

Dry Powder ◽

Specificity And Sensitivity

Background: The choice of the Dry Powder Inhaler (DPI) to prescribe is a critical issue. The estimation of DPIs usability depends on the objective assessment of several indices related to both subjective and objective determinants. The Global Usability Score (GUS) Questionnaire is a comprehensive tool usable for checking, comparing, and ranking inhalers’ usability objectively in real life, but it takes some time to fill.Aim: The aim of this study was to favour the quicker check of DPIs usability in clinical practice by means of a simplified short-form GUS (S-GUS) Questionnaire, while maintaining the high specificity and sensitivity of the original, extended version of the Questionnaire (O-GUS questionnaire).Methods: The usability of the six most prescribed DPIs was assessed in 222 patients with persistent airway obstruction and needing long-term inhalation treatments. LASSO regression and multicollinearity test were used to select the subset of questions of the O-GUS questionnaire, with the highest information power. Each item was then scored using the corresponding coefficient in the linear regression (normalized at 50 as the O-GUS score). Agreement between the original and the short-form questionnaire was evaluated using the Cohen’s kappa statistic (κ). The overall S-GUS values obtained for each DPI were then compared to those from the O-GUS, in the same patients, using a Bayesian indirect comparison (IC) model.Results: After the statistical selection of the items mostly contributing to the overall score, the novel S-GUS questionnaire consists of twelve items only. Nine items are related to patients’ opinion before DPIs handling, and three to the nurse’s assessment after DPIs practicality. O-GUS and S-GUS score were strongly correlated (R2=0.9843, p<0.0001) and the usability score calculated for each DPI by means of the O- and of S- GUS overlapped almost completely (κ=84.5%, 95% CI 81.3% to 89.2%). Furthermore, S-GUS was much faster to complete than O-GUS (mean time 6.1 vs 23.4 minutes, p<0.001). Estimates of S-GUS, obtained from the IC model, allowed to propose a simple classification of usability: “good” by GUS values >25; “pretty good” by values ≤25≥15, and “insufficient” by values <15.Conclusions: The S-GUS proves as much specific and suitable as the extended O-GUS questionnaire in measuring DPIs usability, while maintaining the same high sensitivity. As the time required for its use is quite shorter, S-GUS is also particularly suitable and helpful in current clinical practice.

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The Impact of Flow rate on Inhaler Dose Delivery from a Dry Powder Inhaler using a Two Stage Impinger

ZANCO Journal of Pure and Applied Sciences ◽

10.21271/zjpas.30.4.8 ◽

2018 ◽

Vol 30 (4) ◽

Keyword(s):

Flow Rate ◽

Dry Powder Inhaler ◽

Dose Delivery ◽

Dry Powder ◽

Two Stage ◽

The Impact

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Need of education for dry powder inhaler storage and retention – a patient-reported survey

Multidisciplinary Respiratory Medicine ◽

10.4081/mrm.2016.314 ◽

2016 ◽

Vol 11 ◽

Author(s):

Birger Norderud Lærum ◽

Gunilla Telg ◽

Georgios Stratelis

Keyword(s):

Real Life ◽

Dry Powder Inhaler ◽

Patient Characteristics ◽

Storage Conditions ◽

Dry Powder ◽

Expiry Date ◽

Patient Reported ◽

Asthma Patients ◽

On Line ◽

Inhaler Devices

Background: Dry powder inhalers (DPIs) are the most commonly used devices in asthma treatment in the Nordic countries. As new DPIs become available, patients are likely to be exposed to more than one type of device, with variable optimal handling. The aim was to examine real life storage and retention of multidose DPIs in patients with asthma. Methods: This patient-reported survey on real life storage and retention of DPIs included asthma patients using multidose DPIs. Basic patient characteristics, information on inhaler use and storage, check of expiry date, and concurrent inhaler use was examined using an on line questionnaire. Results: A total of 738 patients were included with a median age of 41 years, out of which 83 % were women. Sixty-three per cent reported storage conditions pre-defined as risk locations for their maintenance inhaler and 38 % of the responding patients had more than one maintenance inhaler in use at the same time. Two thirds of the study population checked inhaler expiry date less than monthly or not at all. Use after expiry date was frequently reported. Two thirds of the patients had not received information on DPI storage, either from their doctor and/or nurse or at the pharmacy. Conclusions: This patient reported survey indicates that two thirds of the patients store their inhaler devices in suboptimal conditions, and only a minority had received instruction regarding inhaler handling. Non awareness of inhalers’ expiry dates and use of more than one maintenance inhaler simultaneously was common. As inhaler mishandling may impact device functionality, improved communication and patient education is needed.

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The Impact of Angiotensin-II Receptor Blockers on Cardiovascular Events in Hypertensive Patients – Evidence from Real-life Databases

European Cardiology Review ◽

10.15420/ecr.2010.6.3.33 ◽

2010 ◽

Vol 6 (3) ◽

pp. 33

Author(s):

Robert J Petrella ◽

Keyword(s):

Angiotensin Ii ◽

Antihypertensive Drugs ◽

Real Life ◽

Angiotensin Ii Receptor Blockers ◽

Angiotensin Ii Receptor ◽

Real World Setting ◽

Actual Experience ◽

Receptor Blockers ◽

Randomised Controlled ◽

The Impact

It is widely recognised that hypertension is a major risk factor for the development of future cardiovascular (CV) events, which in turn are a major cause of morbidity and mortality. Blood pressure (BP) control with antihypertensive drugs has been shown to reduce the risk of CV events. Angiotensin-II receptor blockers (ARBs) are one such class of antihypertensive drugs and randomised controlled trials (RCTs) have shown ARB-based therapies to have effective BP-lowering properties. However, data obtained under these tightly controlled settings do not necessarily reflect actual experience in clinical practice. Real-life databases may offer alternative information that reflects an uncontrolled real-world setting and complements and expands on the findings of clinical trials. Recent analyses of practice-based real-life databases have shown ARB-based therapies to be associated with better persistence and adherence rates and with superior BP control than non-ARB-based therapies. Analyses of real-life databases also suggest that ARB-based therapies may be associated with a lower risk of CV events than other antihypertensive-drug-based therapies.

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