Plume spray force of three HFA-propelled ICS/LABA combination inhalers

Tuohy, John; Marshall, Jonathan; Danagher, Helen

doi:10.1183/1393003.congress-2017.pa524

Cited by 3 publications

(5 citation statements)

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“…When the plume spray force of flutiform k-haler was compared with that of two ICS/LABA conventional pMDIs, the k-haler device had the lowest spray force, with the greatest difference (≈ 70-87%) evident at distances of 60-95 mm, which is typical of the distance between an inhaler mouthpiece and the back of the throat [13]. Compared with the pMDIs, the k-haler device also had a more consistent plume force, which may in part be because it is a BTI and thus has none of the actuation speed variability of press-and-breathe devices.…”

Section: Drug Delivery Propertiesmentioning

confidence: 99%

“…Differences in the properties of the device propellants may also have contributed to the observed difference in plume force. For instance, the boiling point of the k-haler device propellant (apaflurane HFA-227; − 16.4 °C) is higher than that of the propellant of some other pMDIs (norflurane HFA-134a; − 26.5 °C), with resultant differences in evaporation rate and thus, likely, plume force [13]. The particle size and lung deposition of fluticasone and formoterol delivered via the flutiform k-haler [14] are comparable to those delivered by the flutiform (fluticasone propionate + formoterol fumarate) pMDI [15].…”

Section: Drug Delivery Propertiesmentioning

confidence: 99%

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K-haler® breath-triggered inhaler: a profile of the properties of the device

Deeks

Lyseng‐Williamson

2019

Drugs Ther Perspect

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The k-haler ® device is a new breath-triggered pressurized metered-dose inhaler (BTI). Its breath-triggered mechanism employs unique 'kinked-hose valve' technology (k-valve™) and is easy to actuate. In vitro, the k-haler device required less respiratory power, which is affected by the resistance of the device, for dose release than a dry powder inhaler (DPI), potentially making it suitable for a wider range of patients, including those with a low inspiratory flow rate. It has a lower, more consistent plume force than conventional press-and-breathe pressurized metered-dose inhalers (pMDIs), has high fineparticle fraction and pulmonary deposition rates, and, in contrast to conventional pMDIs (but like other BTIs and DPIs), does not require actuation-inhalation coordination. The k-haler device is compact, has an easy-to-read dose counter, a connected mouthpiece and is simple to use, with limited data indicating that more patients are satisfied with the device than they are with some DPIs and that many patients prefer it over some commonly used inhalers. To facilitate correct use, the packaging of the k-haler contains simple how-to-use instructions and diagrams, as well as a patient information leaflet. A number of inhaled products may be suitable for administration via the k-haler device. Adis evaluation of the k-haler ® device in obstructive lung disordersBreath-triggered pressurized metered-dose inhaler that releases drug dose via unique 'kinked-hose valve ' technology (k-valve™) Simple to use/actuate; requires less inspiratory power for dose release than a dry-powder inhaler Lower, more consistent plume force than a conventional pressurized metered-dose inhaler High fine-particle fraction and pulmonary deposition rates Largely preferred over some commonly used inhalers

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Section: Drug Delivery Propertiesmentioning

confidence: 99%

Section: Drug Delivery Propertiesmentioning

confidence: 99%

K-haler® breath-triggered inhaler: a profile of the properties of the device

Deeks

Lyseng‐Williamson

2019

Drugs Ther Perspect

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“…In a study that compared the plume force of FP/ FORM 125/5 μg K-haler®, fluticasone propionate/salmeterol xinafoate 125/25 μg (FP/SAL) from the Seretide® Evohaler® pMDI, and 125/25 μg FP/SAL from the Sirdu-pla® pMDI, the FP/FORM K-haler® plume was 70-87% less forceful than the Seretide® and Sirdupla® plumes, at 60 to 95 mm distances [44]. This can decrease drug impaction at the back of the throat and improve delivery to the lungs.…”

Section: Documentation Of Added Therapeutic Value and Place In The Trmentioning

confidence: 99%

“…The FP/FORM pulmonary bioavailability administered via the k-haler® was similar to the levels achieved when administered via the pMDI without a spacer; hence, the k-haler® would be expected to provide similar efficacy to the pMDI [43][44][45][46].…”

Section: Fp/form K-haler® Pulmonary Bioavailabilitymentioning

confidence: 99%

Asthma management with breath-triggered inhalers: innovation through design

Morais‐Almeida

Pité

Cardoso

et al. 2020

asthma res and pract

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Background: Asthma affects the lives of hundred million people around the World. Despite notable progresses in disease management, asthma control remains largely insufficient worldwide, influencing patients' wellbeing and quality of life. Poor patient handling of inhaling devices has been identified as a major persistent problem that significantly reduces inhaled drugs' efficacy and is associated with poor adherence to treatment, impairing clinical results such as asthma control and increasing disease-related costs. We herein review key research and development (R&D) innovation in inhaler devices, highlighting major real-world critical errors in the handling and inhalation technique with current devices and considering potential solutions. Furthermore, we discuss current evidence regarding breath-triggered inhalers (BTI). Main body: The two most common significant problems with inhalers are coordinating actuation and inhalation with pressurized metered-dose inhalers (pMDIs), and the need to inhale forcibly with a dry powder inhaler. BTI R&D plans were designed to overcome these problems. Its newest device k-haler® has several other important features, generating a less forceful aerosol plume than previous pMDIs, with efficient drug delivery and lung deposition, even in patients with low inspiratory flow. The local and systemic bioavailability of fluticasone propionate and formoterol (FP/FORM) administered via k-haler® has been shown to be therapeutically equivalent when administered via the previous FP/FORM pMDI. This device requires very few steps and has been considered easy to use (even at first attempt) and preferred by the patients in a randomized crossover study. In our country, FP/FORM k-haler is available without additional costs compared to FP/FORM pMDI. All devices continue to require education and regular checking of the correct inhalation technique. Conclusion: BTI R&D can bring advantage over current available inhalers, avoiding the two most common identified critical errors in inhalation technique. K-haler® BTI is currently available, without an increased cost, and approved for adolescents and adults with asthma in whom treatment with inhaled combined therapy with longacting beta 2-agonists and corticosteroids is indicated. Its attractive and practical design to facilitate its use has been awarded. K-haler® represents added value through innovation to fulfill actual asthma patient needs, thus with potential relevant impact in asthma management and effective control.

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“…The plume force of the FP/FORM k-haler (125/5 μg) was compared with that of Seretide and Sirdupla ® (Mylan EMEA, Saint Priest, France) pMDIs (both FP/salmeterol xinafoate [SAL]; 125/ 25 μg) in vitro [51]. The typical distance between an inhaler and the back of the throat is 60-95 mm in adults, so plume force was measured at multiple distances up to 95 mm using a plastic disk target attached to a sensitive load cell, connected to a force tester.…”

Section: In Vitro Plume Force Studymentioning

confidence: 99%

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

Usmani

Roche

Marshall

et al. 2019

Expert Opinion on Drug Delivery

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Introduction: Incorrect inhaler technique is one reason why the efficacies of inhaled asthma treatments in clinical trials and effectiveness in the real world differ. Inhaler technique is critical for drug delivery to the lungs; incorrect technique negatively impacts asthma control and long-term outcomes. Breath-triggered inhalers (BTIs) can simplify drug administration and are suitable for most patients, including those with reduced inspiratory flow. Until recently, no inhaled corticosteroid/long-acting β 2-agonist combination BTI was available in Europe. The flutiform ® (fluticasone propionate/formoterol fumarate [FP/FORM]) k-haler ® is the first combination BTI now approved in Europe for asthma maintenance treatment. Areas covered: We review studies examining the challenges posed to patients by different inhaler types and explore evidence demonstrating the clinical efficacy of FP/FORM administered via a pressurized metered-dose inhaler. We also review the pharmacokinetic/pharmacodynamic studies supporting FP/ FORM k-haler use, and consider data showing high lung deposition with the device. Finally, we review patient experiences using the BTI, device characteristics, and health economic aspects. Expert opinion: Despite the availability of therapies, asthma control levels remain low, and there is a clear need for easy-to-use inhalers. Research to increase our understanding of critical errors with each inhaler and how to overcome them is important for improving care.

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Plume spray force of three HFA-propelled ICS/LABA combination inhalers

Cited by 3 publications

References 0 publications

K-haler® breath-triggered inhaler: a profile of the properties of the device

K-haler® breath-triggered inhaler: a profile of the properties of the device

Asthma management with breath-triggered inhalers: innovation through design

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

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Plume spray force of three HFA-propelled ICS/LABA combination inhalers

Cited by 3 publications

References 0 publications

K-haler® breath-triggered inhaler: a profile of the properties of the device

K-haler® breath-triggered inhaler: a profile of the properties of the device

Asthma management with breath-triggered inhalers: innovation through design

An innovative corticosteroid/long-acting β2-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

Contact Info

Product

Resources

About

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma