A Novel Multidose Dry Powder Inhaler Demonstrates Consistent Aerodynamic Features.

Greguletz, Roland; Fyrnys, Beatrix; Goede, J; Boer, Anne H. de; Frijlink, H.W.

doi:10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a4578

Cited by 4 publications

(5 citation statements)

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“…The reproducibility of the aerodynamic aerosol quality delivered by the inhaler across and between different large‐scale production batches (commercial batch size > 75,000 inhalers) has been assessed in vitro (20). Inspiratory flow rates through inhalers taken from nine different batches ( n = 20 inhalers per batch) were determined at a pressure drop of 4.0 kPa (Figure 3).…”

Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

“… Inspiratory flow rate through the Genuair ® inhaler determined at a pressure drop of 4.0 kPa for 20 inhalers randomly taken from nine different batches (20) …”

Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

“…The inhaler has been shown to function reliably under thermal and mechanical stress conditions that would represent the extremes for storage during routine patient use. A total of 48 inhalers, randomly selected from one production batch, were subjected to one of the following treatments (six inhalers per Figure 3 Inspiratory flow rate through the Genuair Ò inhaler determined at a pressure drop of 4.0 kPa for 20 inhalers randomly taken from nine different batches (20) treatment): cold storage (2-8°C) for 3 or 8 days; humid storage [40°C/75% relative humidity (RH)] for 3 or 8 days; hot storage (60°C) for 1 or 6 h; or vibrational loading for 1 h at an amplitude of approximately 1.5 mm/g using a vibrating sieve device (24). After each stress treatment, all features and functions of the inhalers were tested and found to comply with all performance requirements.…”

Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

“…In vitro experiments have demonstrated that the inspiratory flow rate through the inhaler is approximately 65 l/min at a pressure drop of 4 kPa (20). The novel design of the dispersion set (mouthpiece and cyclone unit) enhances the fluid and particle dynamics to ensure effective deagglomeration of the inhalation powder into a suitable aerosol, even at low inhalation flow rates and volumes (21,22).…”

Section: Inhaler Designmentioning

confidence: 99%

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The Genuair® inhaler: a novel, multidose dry powder inhaler

Chrystyn

Niederlaender

2012

International Journal of Clinical Practice

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This article reviews the Genuair(®) inhaler, a novel, multidose, breath-actuated dry powder inhaler. The inhaler design includes visual and acoustic feedback to reassure patients that they have taken their medication correctly, a dose indicator and a lock-out mechanism to prevent the use of an empty inhaler. The inhaler has medium airflow resistance and uses an optimised dispersion system to ensure effective deagglomeration of the inhalation powder. In vitro studies have demonstrated that the inhaler delivers a reproducible aerodynamic aerosol quality and is reliable under various thermal and mechanical stress conditions. Further studies in vitro have demonstrated that the total emitted dose and fine particle dose are both consistent over a range of inhalation flows from 45 to 95 l/min, as well as being independent of inhalation volume (2 l vs. 4 l) and storage conditions. In healthy subjects, delivery of aclidinium bromide 200 μg via the inhaler achieved high lung deposition (approximately 30% of the metered dose). A further study has shown that patients with moderate or severe chronic obstructive pulmonary disease can generate sufficient inspiratory airflow through the inhaler to reliably inhale the full dose and reset the inhaler. The inhaler has been used to deliver aclidinium in many clinical trials and the available data indicate that it has high acceptability amongst patients.

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Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

“… Inspiratory flow rate through the Genuair ® inhaler determined at a pressure drop of 4.0 kPa for 20 inhalers randomly taken from nine different batches (20) …”

Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

Section: Aerosol Reproducibility and Functional Reliabilitymentioning

confidence: 99%

Section: Inhaler Designmentioning

confidence: 99%

See 2 more Smart Citations

The Genuair® inhaler: a novel, multidose dry powder inhaler

Chrystyn

Niederlaender

2012

International Journal of Clinical Practice

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“…3 • The Genuair ®** inhaler is a novel, breath-actuated multidose, dry powder inhaler designed for the effective delivery of various types of inhaled drugs. 4 It has been used to administer aclidinium bromide in Phase III studies and is being investigated as a device for the delivery of other respiratory drugs.…”

Section: Introductionmentioning

confidence: 99%