The Respimat® Soft Mist Inhaler: Implications of Drug Delivery Characteristics for Patients

Iwanaga, Takashi; Tohda, Yuji; Nakamura, Shuhei; Suga, Yasunori

doi:10.1007/s40261-019-00835-z

Cited by 47 publications

(40 citation statements)

References 51 publications

(99 reference statements)

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“…These results provide support for benefits of nebulization in a wider set of patients who may show variable tidal volumes and breathing patterns, whereas DPIs may be more beneficial among patients who are capable of generating the required, device-specific PIF consistently. It is important to note that TIO is also available for delivery using an SMI, which may provide greater advantages for patients having similar breathing patterns to those tested in this study, as SMIs have been shown to have a higher in vitro deposition compared to other inhalers [29,39,40]. The timing of this study in the summer of 2019 coincided with a period in which the HandiHalerÒ was predominantly used for delivery of TIO, and as such led to the use of the HandiHalerÒ as a comparator device in the current analysis.…”

Section: Discussionmentioning

confidence: 99%

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®

Ohar¹,

Bauer²,

Sharma³

et al. 2020

Pulm Ther

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Introduction: Personalized therapy for patients with COPD requires appropriate choice of drug and delivery device. Inhalers and nebulizers vary in their drug delivery characteristics, particularly the need for passive or active patient inhalation for appropriate drug dispersal and delivery. In this in vitro analysis, we assessed the aerosol performance and drug delivery of two long-acting muscarinic antagonists, glycopyrrolate (GLY; 25 lg solution; 1 ml) and tiotropium (TIO; 18 lg powder) through their respective delivery systems: the eFlowÒ Closed System (CS) vibrating membrane nebulizer and the HandiHalerÒ dry-powder inhaler (DPI). Methods: The aerosol performances of the eFlowÒ CS nebulizer and the HandiHalerÒ were determined using the Next Generation cascade Impactor. The delivered dose of GLY and TIO was determined using different breathing patterns, which varied in tidal volume and peak inspiratory flow rate, respectively, to simulate breathing conditions ranging from normal to severe obstruction. Results: Aerodynamic particle analysis showed generally similar mass median aerodynamic diameter (MMAD, range, 3.6-4.6 lm) and fine particle fraction (FPF, range, 48.2%-63.7%) with GLY delivered using the eFlowÒ CS nebulizer under all breathing patterns tested. TIO, delivered via the HandiHalerÒ, showed variations in MMAD (range, 3.8-5.8 lm) and FPF (range, 16.1%-32.4%) under different inspiratory flow rates. The majority of GLY was deposited in stages 2-5 of the impactor, which corresponds with particle sizes in the respirable range (\ 5 lm), whereas a large proportion of TIO was deposited in the throat/mouthpiece pre-separator, irrespective of test conditions. The median residual dose of GLY with eFlowÒ CS was notably lower compared to that of TIO with HandiHalerÒ (2.4%-4.4% vs. 40%-67%, respectively). Conclusions: These simulation results highlight the different deposition patterns generated by a DPI device and a vibrating membrane nebulizer, which may help inform device selection and treatment decision in COPD management.

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Section: Discussionmentioning

confidence: 99%

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®

Ohar¹,

Bauer²,

Sharma³

et al. 2020

Pulm Ther

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“…The use of ethanol in the solutions delivered from the Respimat™ soft mist inhaler, e.g. tiotropium (Spiriva®, Boehringer Ingelheim) enhances the solubilization properties of the medium and facilitates a hand held aqueous based system with accurate and reproducible performance in delivering very low doses (<10 μg) on a single breath analogous to a metered dose inhaler [ 30 , 31 ].…”

Section: Formulationmentioning

confidence: 99%

Emerging trends in inhaled drug delivery

Hickey

2020

Advanced Drug Delivery Reviews

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Ideally, inhaled therapy is driven by the needs of specific disease management. Lung biology interfaces with inhaler performance to allow optimal delivery of therapeutic agent for disease treatment. Inhalation aerosol products consist of the therapeutic agent, formulation, and device. The manufacturing specifications on each of the components, and their combination, allow accurate and reproducible control of measures of quality and invitro performance. These product variables in combination with patient variables, including coordination skill during inhaler use, intrinsic lung biology, disease and consequent pulmonary function, contribute to drug safety and efficacy outcomes. Due to the complexity of pulmonary drug delivery, predicting biological outcomes from first principles has been challenging. Ongoing research appears to offer new insights that may allow accurate prediction of drug behavior in the lungs. Disruptive innovations were characteristic of research and development in inhaled drug delivery at the end of the last century. Although there were relatively few new inhaled products launched in the first decade of the new millennium it was evident that the earlier years of exploration resulted in maturation of commercially successful technologies. A significant increase in new and generic products has occurred in the last decade and technical, regulatory and disease management trends are emerging. Some of these developments can trace their origins to earlier periods of creativity in the field while others are a reflection of advances in other areas of basic and computer, sciences and engineering. Select biological and technical advances are highlighted with reflections on the potential to impact future clinical and regulatory considerations.

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“…Scintigraphic studies have shown that when compared to a CFC-based pMDI, lung deposition with a soft mist inhaler is up to 50% higher, and oropharyngeal deposition is lower. 27,28 However, a recent meta-analysis has reported that device use errors similar to those with pMDIs occurred in approximately 60% of patients who used soft mist inhalers. The most common errors were breathing errors, hand-breath coordination, and difficulties with priming the inhalation device.…”

Section: Current Inhalation Delivery Systemsmentioning

confidence: 99%

<p>Nebulized Therapies in COPD: Past, Present, and the Future</p>

Barjaktarevic,

Milstone

2020

COPD

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Current guidelines recommend inhalation therapy as the preferred route of drug administration for treating patients with chronic obstructive pulmonary disease (COPD). Inhalation devices consist of nebulizers and handheld inhalers, such as dry-powder inhalers (DPIs), pressurized metered-dose inhalers (pMDIs), and soft mist inhalers (SMIs). Although pMDIs, DPIs and SMIs may be appropriate for most patients with COPD, certain patient populations may have challenges with these devices. Patients who have cognitive, neuromuscular, or ventilatory impairments (and receive limited assistance from caregivers), as well as those with suboptimal peak inspiratory flow may not derive the full benefit from handheld inhalers. A considerable number of patients are not capable of producing a peak inspiratory flow rate to overcome the internal resistance of DPIs. Furthermore, patients may have difficulty coordinating inhalation with device actuation, which is required for pMDIs and SMIs. However, inhalation devices such as spacers and valved holding chambers can be used with pMDIs to increase the efficiency of aerosol delivery. Nebulized treatment provides patients with COPD an alternative administration route that avoids the need for inspiratory flow, manual dexterity, or complex hand-breath coordination. The recent approval of two nebulized long-acting muscarinic antagonists has added to the extensive range of nebulized therapies in COPD. Furthermore, with the availability of quieter and more portable nebulizer devices, nebulization may be a useful treatment option in the management of certain patient populations with COPD. The aim of this narrative review was to highlight recent updates and the treatment landscape in nebulized therapy and COPD. We first discuss the pathophysiology of patients with COPD and inhalation device considerations. Second, we review the updates on recently approved and newly marketed nebulized treatments, nebulized treatments currently in development, and technological advances in nebulizer devices. Finally, we discuss the current applications of nebulized therapy in patients with COPD.

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The Respimat® Soft Mist Inhaler: Implications of Drug Delivery Characteristics for Patients

Cited by 47 publications

References 51 publications

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®

Emerging trends in inhaled drug delivery

<p>Nebulized Therapies in COPD: Past, Present, and the Future</p>

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