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      Assessment of inhalation flow patterns of soft mist inhaler co-prescribed with dry powder inhaler using inspiratory flow meter for multi inhalation devices

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          Abstract

          The patients’ inhalation flow pattern is one of the significant determinants for clinical performance of inhalation therapy. However, the development of inhalation flow meters for various inhalation devices has been unable to keep up with the increasing number of newly launched inhalation devices. In the present study, we developed simple attachment orifices for the inhalation flow pattern monitoring system, which are suitable for all commercial inhalers, and investigated the efficacy of the system on the clinical inhalation instruction for patients co-prescribed dry powder inhaler (DPI) and soft mist inhaler (SMI). First, we constructed simple attachment orifices that were adjusted for 13 commercial inhalers, and examined the correlation between orifice and inhalation device. Second, the inhalation flow patterns (peak inspiratory flow rate, PIFR; inhalation duration time, DT) of patients prescribed a combination of DPI and SMI were monitored before and after inhalation instruction. The inhalation resistance of commercial inhalers are listed in the following order; Twincaps ® > Handihaler ® > Swinghaler ® = Clickhaler ® > Twisthaler ® > Turbuhaler ® > Jenuair ® > Diskus ® = Ellipta ® > Diskhaler ® > Breezhaler ® > Respimat ® = pMDI. The pressure drop via orifice was significantly correlated with that via the commercial inhaler. For the confirmation, all participants achieved the DPI criterion of PIFR. On the other hand, 4 participants (6 clinical visits) of 10 experimented participants could not achieve the essential criterion of DT (> 1.5 sec) for SMI, but all participants improved their duration time after inhalation instruction by pharmacists (P<0.05). In the present study, we successfully developed simple attachment orifice suitable for 13 commercial inhalation devices. These data suggested that our simple attachment orifices for the inhalation flow pattern monitoring system can detect patients with inadequate inhalation patterns via SMI.

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          Most cited references31

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          Tiotropium Respimat inhaler and the risk of death in COPD.

          Tiotropium delivered at a dose of 5 μg with the Respimat inhaler showed efficacy similar to that of 18 μg of tiotropium delivered with the HandiHaler inhalation device in placebo-controlled trials involving patients with chronic obstructive pulmonary disease (COPD). Although tiotropium HandiHaler was associated with reduced mortality, as compared with placebo, more deaths were reported with tiotropium Respimat than with placebo.
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            Aerosol drug delivery: developments in device design and clinical use.

            Aerosolised drugs are prescribed for use in a range of inhaler devices and systems. Delivering drugs by inhalation requires a formulation that can be successfully aerosolised and a delivery system that produces a useful aerosol of the drug; the particles or droplets need to be of sufficient size and mass to be carried to the distal lung or deposited on proximal airways to give rise to a therapeutic effect. Patients and caregivers must use and maintain these aerosol drug delivery devices correctly. In recent years, several technical innovations have led to aerosol drug delivery devices with efficient drug delivery and with novel features that take into account factors such as dose tracking, portability, materials of manufacture, breath actuation, the interface with the patient, combination therapies, and systemic delivery. These changes have improved performance in all four categories of devices: metered dose inhalers, spacers and holding chambers, dry powder inhalers, and nebulisers. Additionally, several therapies usually given by injection are now prescribed as aerosols for use in a range of drug delivery devices. In this Review, we discuss recent developments in the design and clinical use of aerosol devices over the past 10-15 years with an emphasis on the treatment of respiratory disorders. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique.

              Patient compliance, inhalation devices, and inhalation techniques influence the effectiveness of inhaled medications. This article presents the results of a systematic literature review of studies measuring compliance with inhaled corticosteroids, measuring inhalation technique with different inhalation devices, and estimating the proportion of inhaled drug that is deposited in the lung. Overall, patients took the recommended doses of inhaled medication on 20 to 73% of days. Frequency of efficient inhalation technique ranged from 46 to 59% of patients. Education programs have been shown to improve compliance and inhalation techniques. The lung deposition achieved with different inhalers depends on particle size as well as inhaler technique. This review demonstrates that multiple factors may come between a prescription of an inhaled corticosteroid and the arrival of that medicine at its target organ, the lung.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SoftwareRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SoftwareRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SoftwareRole: VisualizationRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: SupervisionRole: ValidationRole: Writing – review & editing
                Role: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                20 February 2018
                2018
                : 13
                : 2
                : e0193082
                Affiliations
                [1 ] Department of Pharmacy, Shiga University of Medical Science Hospital, Otsu, Shiga, Japan
                [2 ] Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Kyoto Pharmaceutical University, Kyoto, Kyoto, Japan
                [3 ] Hitachi Automotive Systems, Ltd., Isesaki, Gunma, Japan
                [4 ] Department of Medicine, Division of Respiratory Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan
                [5 ] Kinki-Chozai Kadono Sanjo Pharmacy, Kyoto, Kyoto, Japan
                [6 ] Oguma Family Clinic, Kusatsu, Shiga, Japan
                [7 ] Oral Rehabilitation, Niigata University Medical and Dental Hospital, Niigata, Niigata, Japan
                [8 ] Department of Respiratory Internal Medicine, St. Marianna University, School of Medicine, Yokohama-City Seibu Hospital, Yokohama, Kanagawa, Japan
                University of Sydney, AUSTRALIA
                Author notes

                Competing Interests: YK and YN received lecture fees from GlaxoSmithKline and Boehringer Ingelheim GmbH, respectively. YN received research funding from Novartis Pharma AG and Otsuka Pharmaceutical Co, Ltd. MY received research funding from Novartis Pharma AG. SN, TOk, and KIs are employees of Hitachi Automotive Systems, Ltd. These affiliations do not alter our adherence to PLOS ONE policies on sharing data and materials.

                [¤]

                Current address: College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, Shiga, Japan

                Author information
                http://orcid.org/0000-0001-8344-2469
                Article
                PONE-D-17-10163
                10.1371/journal.pone.0193082
                5819805
                29462195
                52e3f3ea-96fa-4d44-b6fc-7390980aae45
                © 2018 Hira et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 15 March 2017
                : 22 January 2018
                Page count
                Figures: 6, Tables: 3, Pages: 12
                Funding
                Funded by: Hitachi Automotive Systems, Ltd.
                Award Recipient :
                Funded by: Hitachi Automotive Systems, Ltd.
                Award Recipient :
                Funded by: Hitachi Automotive Systems, Ltd.
                Award Recipient :
                SN, TOk, and KIs are employees of Hitachi Automotive Systems, Ltd. The funder provided support in the form of salaries for authors, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.
                Categories
                Research Article
                Biology and Life Sciences
                Physiology
                Physiological Processes
                Respiration
                Inhalation
                Medicine and Health Sciences
                Physiology
                Physiological Processes
                Respiration
                Inhalation
                Physical Sciences
                Physics
                Classical Mechanics
                Continuum Mechanics
                Fluid Mechanics
                Fluid Dynamics
                Flow Rate
                Physical Sciences
                Materials Science
                Materials by Structure
                Powders
                Biology and Life Sciences
                Biotechnology
                Medical Devices and Equipment
                Medicine and Health Sciences
                Medical Devices and Equipment
                People and Places
                Geographical Locations
                Asia
                Japan
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Pharmacists
                Medicine and Health Sciences
                Pulmonology
                Chronic Obstructive Pulmonary Disease
                Medicine and Health Sciences
                Pharmaceutics
                Drug Delivery
                Custom metadata
                All relevant data are within the paper.

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