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Performance Data of Respimat® SMI

Please find a summary of abstracts and publications concerning cloud velocity and duration, high fine particle fraction and lung deposition data for Respimat® SMI compared to other inhaler devices.

Click on the links below each summary to order a printed abstract of the study for free.

  • The cloud velocity and duration

    Dhand R Aerosol Plumes: Slow and Steady Wins The Race J Aerosol Med 2005; Vol 18,3: 261-63

    Based on the fact that chlorofluoro (CFC)-metered dose inhalers (MDIs) are now being retired due to environmental reasons fixed in the Montreal Protocol the author of this inhaler review discusses the shortcoming of CFC-pMDIs, gives an overview on more environmentally friendly alternatives and upcoming devices.

    Hochrainer D, et al. Comparison of Aerosol Velocity and Spray Duration of Respimat® Soft Mist™ Inhaler and Pressurized Metered Dose Inhalers. J Aerosol Med 2005; Vol 18, 3: 273-282

    Apart from particle size distribution, spray velocity and spray duration are very important aerosol characteristics that influence lung deposition of inhaled drugs. The objective of this study was to compare the velocity and spray duration of the aerosol cloud produced by Respimat® SMI with those from a variety of CFC- and HFA - pMDIs. A video recording method was used to determine cloud velocity and spray duration. The soft mist produced by Respimat® SMI moved much more slowly and had a prolonged duration than aerosol clouds from pMDIs.

    Hochrainer D, et al. Comparison of cloud velocities delivered from Respimat® Soft Mist™ Inhaler or MDIs. J Aerosol Med 2001; 14: 386 (Abstract P1-5).

    A comparison of the cloud velocities and durations from Respimat® Soft Mist™ Inhaler with those from various MDIs, using a video camera. Respimat® SMI produced a Soft Mist™, which was considerably slower and more prolonged than the clouds produced by MDIs. The Soft Mist™ improved lung deposition and reduced oropharyngeal deposition.

    Zierenberg B. Optimizing the in-vitro performance of Respimat. J Aerosol Med 1999; 12(Suppl 1): S19-S24.

    An overview of the milestones in the development of Respimat® Soft Mist™ Inhaler. Its mechanism of action is discussed, including its use of a coiled spring to replace propellants and the generation of a slow-moving aerosol of Soft Mist™, along with details of studies examining the size and velocity of the aerosol particles.

    Ganderton D. Chairman's summary. J Aerosol Med 1999; 12(Suppl 1): S41-S42.

    A brief overview of the objective of inhaler technology - a stationary or slow-moving cloud of particles generated in a way that permits synchrony with slow inspiration by the patient - accompanied by details of how Respimat® Soft Mist™ Inhaler fits these criteria.

  • The high fine particle fraction

    Wachtel H, et al. Improved assessment of inhaler device performance using laser diffraction. Respiratory Drug Delivery VIII 2002, 379-381.

    A study investigating a new method - laser diffraction - of measuring particle size distribution of aqueous formulations released from Respimat® SMI (a routine task during the development of new formulations and devices). Laser diffraction and impactor (the GOLD standard method) correlated well, supporting the use of laser diffraction from many routine investigations, since it offers substantial time savings.

    Hochrainer D, et al. Evaporation and disposition of ethanol droplets from the Respimat®. J Aerosol Med 1999; 12: 142 (Abstract 201)

    Respimat® Soft Mist™ Inhaler delivers an aqueous or ethanolic drug solution. This study investigates how much ethanol a patient can receive by deposition of droplets from inhaling one puff. A maximum of 4µl ethanol could be deposited although, at a distance from the nozzle, the majority of drug particles are present without ethanol and are so small that they can be inhaled into the lung.

  • The nozzle system

    Spallek et al. Optimizing nozzles for soft mist inhalers. Respiratory Drug Delivery VIII 2002, 375-378.

    A study to find the ideal nozzle to generate a Soft Mist™ of aerosolised particles from Respimat® Soft Mist™ Inhaler. A nozzle in which two jets of aqueous drug solution impact each other was best suited to Respimat® Soft Mist™ Inhaler, taking into account the high mechanical robustness and the good results of nozzle reliability.

  • Lung deposition data

    Higher lung deposition with Respimat® Soft Mist™ Inhaler than HFA-MDI in COPD patients with poor technique

    Peter Brand, 1 Bettina Hederer, 2 George Austen, 3 Helen Dewberry, 3 and Thomas Meyer 4

    1     RWTH, Aachen, Germany
    2 Boehringer Ingelheim, Ingelheim, Germany
    3 Boehringer Ingelheim, Bracknell, UK
    4 Inamed Research, Gauting, Germany

    Int J Chron Obstruct Pulmon Dis. 2008 December; 3(4): 763–770

    Aerosols delivered by Respimat® Soft Mist™ Inhaler (SMI) are slower-moving and longer-lasting than those from pressurized metered-dose inhalers (pMDIs), improving the efficiency of pulmonary drug delivery to patients. In this four-way cross-over study, adults with chronic obstructive pulmonary disease (COPD) and with poor pMDI technique received radiolabelled Berodual® (fenoterol hydrobromide 50 μg/ipratropium bromide 20 μg) via Respimat® SMI or hydrofluoroalkane (HFA)-MDI (randomized order) on test days 1 and 2, with no inhaler technique training. The procedure was repeated on test days 3 and 4 after training. Deposition was measured by gamma scintigraphy. All 13 patients entered (9 males, mean age 62 years; FEV1 46% of predicted) inhaled too fast at screening (peak inspiratory flow rate [IF]: 69–161 L/min). Whole lung deposition was higher with Respimat® SMI than with pMDI for untrained (37% of delivered dose vs 21% of metered dose) and trained patients (53% of delivered vs 21% of metered dose) (pSign-Test].15; pANOVA < = 0.05). Training also improved inhalation profiles (slower average and peak IF as well as longer breath-hold time). Drug delivery to the lungs with Respimat® SMI is more efficient than with pMDI, even with poor inhaler technique.

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    Brand P et al. Respimat® Soft Mist™ inhaler preferred to Diskus® by Patients with COPD and /or Asthma J Aerosol Med, Vol 20, Nr 2, 2007, P 165

    The prupose of this study was to measure lung deposition in COPD patients with poor inhaler technique using Respimat® SMI and HFA-pMDIs. Patient lung deposition was measured with their usual method before training and after teaching them the correct inhalation method. This study demonstrated that drug delivery with Respimat® SMI is more efficient than with an HFA-MDI even in patients with poor technique. Inhaler training further improved aerosol deposition for Respimat® SMI but made almost no difference to the profile for HFA-pMDI.

    Newman SP. Use of Gamma Scintigraphy to Evaluate the Performance of New Inhalers. J Aerosol Med 1999; 12: (Suppl 1):25-31.

    Comparison of drug/lung deposition from Respimat® SMI and pMDI, measured through gamma scintigraphy. Respimat® SMI more than doubles deposition in the lungs compared to pMDIs.

    Newman SP. Use of gamma scintigraphy to evaluate the performance of new inhalers. J Aerosol Med 1999; 12(Suppl 1): S25-S31.

    A review of four studies quantifying the amount of drug deposited in the lung with Respimat® SMI versus pMDI, with and without a spacer device, using gamma scintigraphy. Respimat® Soft Mist™ Inhaler more than doubles deposition in the lungs compared with a pMDI and reduces oropharyngeal deposition.

    Freund BWJ, et al. The Respimat® system (BINEB®): a new approach to inhalation therapy J Aerosol Med 1997; 10: 246 (Abstract SV-5).

    A discussion of the principle behind the Respimat® Soft Mist™ Inhaler device. Studies demonstrate that lung deposition is increased by a factor of 2.5-3 with Respimat® Soft Mist™ Inhaler compared with a CFC-MDI.

    Pavia D. Efficacy and safety of inhalation therapy in Chronic Obstructive Pulmonary Disease and asthma Respirology 1997;2 (Suppl 1): S5-S10.

    An overview of factors affecting inhaled drug delivery and the various devices currently in use (MDIs, DPIs, nebulizers). Details of the ideal aerosol drug delivery device are accompanied by Respimat® Soft Mist™ Inhaler. Data demonstrate its unique mechanism of action, and its superiority over MDIs in terms of drug deposition in the lung.

  • Inhaler development

    Development of Respimat® Soft Mist™ Inhaler and its clinical utility in respiratory disorders

    Richard N Dalby 1, Joachim Eicher 2, Bernd Zierenberg 2
    1Department of Pharmaceutical Sciences, University of Maryland, Baltimore, MD, USA; 2Boehringer Ingelheim, Ingelheim, Germany

    Medical Devices: Evidence and Research; 2011:4 Pages 145 – 155

    Astract: The Respimat® Soft Mist™ Inhaler (SMI) (Boehringer Ingelheim International GmbH, Ingelheim, Germany) was developed in response to the need for a pocket-sized device that can generate a single-breath, inhalable aerosol from a drug solution using a patient-independent, reproducible, and environmentally friendly energy supply. This paper describes the design and evolution of this innovative device from a laboratory concept model and the challenges that were overcome during its development and scaleup to mass production.

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    In Vitro Validation of a Respimat® Adapter for Delivery of Inhaled Bronchodilators During Mechanical Ventilation

    Dominic Dellweg, M.D., 1 Herbert Wachtel, Ph.D., 2 Ekkehard Höhn, 1 Michael P. Pieper, D.V.M., 2
    Thomas Barchfeld, M.D., 1 Dieter Köhler, M.D., Ph.D., 1 and Thomas Glaab, M.D. 2

    1Hospital Kloster Grafschaft, Department of Respiratory and Critical Care Medicine, Schmallenberg, Germany.
    2     Boehringer Ingelheim, Germany.

    J Aerosol Med., 2011, Volume: 24 Issue 6

    Background: Inhaled bronchodilators are frequently used in patients with chronic obstructive pulmonary disease (COPD). However, there has been no efficient way to administer the long-acting anticholinergic tiotropium to mechanically ventilated patients. The aim of this in vitro study was to compare the fine particle dose (FPD) output of a specifically designed adapter with other accessory devices for the delivery of bronchodilators using the Respimat® (RMT) inhaler by simulating the specific inhalation flow profiles of patients with COPD.

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