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Soft Mist Inhalers
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Stefan Leiner, David Cipolla, Joachim Eicher, Wilbur de Kruijf, Herbert Wachtel
The key elements of the Respimat are shown in Figure 21.1. Medication to be delivered by the Respimat is stored in a cartridge, i.e. an aluminum cylinder with a double-walled, collapsible plastic bag on the inside that contracts once the solution has been withdrawn (Anderson 2006). This ensures that the Respimat capillary is always immersed in the solution until the last actuation, and there is no tailing-off effect as the cartridge is depleted. The Respimat has a locking mechanism and a built-in dose indicator, which reminds patients when a new prescription is required. Currently, in the US, the device and the inserted cartridge need to be replaced after 120 actuations; however, in the EU, three products have been approved recently with a reusable Respimat device. The addition of a preservative to the drug solution prevents microbial contamination once the cartridge has been inserted by the patient prior to first use (Dalby et al. 2004).
A critical perspective on future developments based on the knowledge we have now
Published in Anthony J. Hickey, Heidi M. Mansour, Inhalation Aerosols, 2019
Tania F. Bahamondez-Canas, Jasmim Leal, Hugh D.C. Smyth
Although inhalation therapies date back more than 4000 years (1), the first modern systems are much more recent. For example, the first metered-dose devices were the Medihaler Iso™ and Medihaler Epi™ developed by Riker Laboratories beginning in the mid 1950s. With the first inhaler, pressurized metered-dose inhaler (pMDI), a new era of portable, multidose, metered-dose inhalers began and represented a milestone in the field (2,3). A few decades later, propellant gases used in pMDIs underwent a replacement and reformulation due to chlorofluorocarbon (CFC) ozone depletion issues. The CFC phase-out process was completed in the United States in 2013 (4). Early dry powder inhalers (DPIs) were developed before the first pMDIs (Aerohalor®, Abbott in 1944), but their widespread use was only realized later in response to the phase-out of CFC-propelled pMDIs. Today, DPIs are a widely accepted dosage form, and their use increasing steadily (5). Respimat® is the first of a new generation of active metered-dose devices known as Soft Mist™ Inhalers that have been commercialized and that do not require propellants and/or patient inspiratory effect for actuation (6–8).
Finding White Spaces
Published in Ruchin Kansal, Jeff Huth, Redefining Innovation, 2018
The second step is to identify the position the organization occupies along the identified dimensions relative to competition and internal capabilities, and where it can differentiate and succeed. For example, the RESPIMAT device is Boehringer Ingelheim's platform technology for delivering inhaled medications via a unique soft mist. The company's strong position in the respiratory market represented an advantage on which to build additional functionality for the RESPIMAT device.
Comparison of tiotropium delivery with the ODAPT adapter and a valved holding chamber
Published in Canadian Journal of Respiratory, Critical Care, and Sleep Medicine, 2021
Rym Mehri, Abubakar Alatrash, Nicholas Ogrodnik, Kenny Lee Slew, Edgar A. Matida
The results presented in this study show in vitro medication deposition using a Cascade impactor, mimicking or modeling clinical settings. However, this in vitro data does not perfectly represent in vivo medication deposition, primarily due to differences in lung anatomy and breathing pattern when compared to the experimental setup used. Newman et al.18 investigated lung particle deposition in vitro and in vivo. The authors found that the in vitro FPF (Fine Particle Fraction) was found to overestimate the in vivo lung deposition for the different inhalers tested, but showed similar results for particles less than 3 µm. Although the results found in this present study are expected to predict the particle behavior in the lungs, differences with the whole-lung medication deposition are expected. The results of this study could, therefore, be used to assess in vivo medication deposition for proper usage of the Respimat inhaler in intensive care.
Respimat soft mist inhaler (SMI) in-vitro aerosol delivery with the ODAPT adapter and facemask
Published in Canadian Journal of Respiratory, Critical Care, and Sleep Medicine, 2021
Rym Mehri, Abubakar Alatrash, Edgar A. Matida, Frank Fiorenza
Newman et al.5 conducted two randomized studies using the Respimat SMI in vivo using two different medications (fenoterol and flunisolide). The whole lung deposition, which was measured using gamma scintigraphy, was found to be 39.2% and 44.6% with fenoterol and flunisolide, respectively. Brand et al.6 explored the effect of inhaler technique on lung deposition using the Respimat SMI and a pMDI. For this purpose, 13 male and female subjects with COPD and poor pMDI technique were administered radiolabeled Berodual (fenoterol hydrobromide 50 µg/ipratropium bromide 20 µg) using the Respimat SMI or hydrofluoroalkane (HFA)-MDI, before and after training. The study revealed that proper inhaler technique improved lung deposition for the Respimat SMI, with 37% and 53% medication depositing in the lungs for untrained and trained subjects, respectively. However, the authors found no statistical difference in lung deposition using pMDIs before and after training (21% for untrained and trained subjects).
Comparison between montelukast and tiotropium as add-on therapy to inhaled corticosteroids plus a long-acting β2-agonist in for patients with asthma
Published in Journal of Asthma, 2019
Makoto Hoshino, Kenta Akitsu, Junichi Ohtawa
This was a randomized, open-label, three-arm clinical trial (Figure 1). All patients provided written, informed consent, and the study protocol was approved by our hospital ethics committee. This trial was registered with the University Hospital Medical Information Network (http://www.umin.ac.jp. UMIN000019042). Randomization was performed using a pseudo-random number generator, a supplied seed number, and a fixed-block sequence; the block size was six. During a 4-week run-in period, all patients were given budesonide/formoterol (AstraZeneca, Lund, Sweden) (160/4.5 μg) 2 inhalations twice daily. At the end of the run-in period, the patients were allocated to receive treatment with one of the following for 48 weeks: oral montelukast (MSD, Kenilworth, NJ, USA) (10 mg) once daily; inhaled tiotropium (Respimat® SoftMist inhaler, Boehringer Ingelheim, Ingelheim am Rhein, Germany) (5 μg) once daily; or no add on to the maintenance treatment (budesonide/formoterol). A short-acting β2-agonist was provided as a rescue medication for use when required. After screening, which was conducted before the 4-week run-in period, subsequent clinical visits were scheduled once every 4 weeks during the 48-week treatment period. Spirometry, FeNO measurement, CT examination, blood tests, evaluation of the frequency of exacerbations, and assessment of a quality of life using a questionnaire were conducted during the run-in period and on week 48.