Efficacy and safety of formoterol delivered through the Novolizer®, a novel dry powder inhaler (DPI) compared with a standard DPI in patients with moderate to severe asthma

Otto-Knapp, Ralf; Conrad, Frank; Hosch, S.B.; Metzenauer, P.; Maus, Joachim; Noga, Oliver; Petzold, U.; Kunkel, G.

doi:10.1016/j.pupt.2006.11.003

Cited by 9 publications

(2 citation statements)

References 14 publications

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“…The Genuair ® inhaler has been developed from the Novolizer ® , which is approved and established in Europe (15–17). The inhaler incorporates a number of technological modifications to enhance performance and safety, and has demonstrated efficient dose delivery over a range of inhalation flows achieved by patients.…”

Section: Introductionmentioning

confidence: 99%

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: Introductionmentioning

confidence: 99%

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

Chrystyn

Niederlaender

2012

International Journal of Clinical Practice

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“…[1][2][3] This route directly targets the site of action and reduces the occurrence of systemic adverse effects. In addition, there is increasing interest in the use of pulmonary delivery to administer systemically-acting macromolecules, such as inhaled insulin product.…”

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confidence: 99%

Spray Freeze-Dried Porous Microparticles of a Poorly Water-Soluble Drug for Respiratory Delivery

Niwa

Mizutani

Danjo

2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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Particles of poorly water-soluble drugs were prepared to develop a dry powder inhaler (DPI). Spray freeze-drying (SFD) technique using a four-fluid nozzle (4N), which has been developed by authors, was applied in this research. Ciclosporin and mannitol were used as a poorly water-soluble model drug and a dissolution-enhanced carrier, respectively. The organic solution of ciclosporin and aqueous solution of mannitol were separately and simultaneously atomized through the 4N, and the two solutions were collided with each other at the tip of the nozzle edge. The spray mists were immediately frozen in liquid nitrogen to form a suspension. Then, the iced droplets were freeze-dried to prepare the composite particles of the drug and carrier. tert-Butyl alcohol (t-BuOH) was used as the organic spray solvent due to its relatively high freezing point. The resultant composite particles with varying drug content were characterized depending on their morphological and physicochemical properties. The particles contained amorphous ciclosporin and δ-crystalline mannitol. The characteristic porous structure of SFD particles potentially contributed to their good aerodynamic performance. A series of particles with a similar size distribution and different drug content revealed that the incorporation of mannitol successfully improved the cohesive behavior of ciclosporin, leading to enhanced aerosol dispersion. The dissolution test method using low-volume medium was newly established to simulate the release process from particles deposited on the surface of the bronchus and pulmonary mucosa. The composite with hydrophilic mannitol dramatically improved the in vitro dissolution behavior of ciclosporin in combination with the porous structure of SFD particles.Key words spray freeze-drying; liquid nitrogen; ciclosporin; porous particle; tert-butyl alcohol Inhalation is the most appropriate route to deliver drugs to treat respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis.1-3) This route directly targets the site of action and reduces the occurrence of systemic adverse effects. In addition, there is increasing interest in the use of pulmonary delivery to administer systemically-acting macromolecules, such as inhaled insulin product.4) The aerodynamic size of drug particles should be 5-6 µm or less for optimal airway deposition.5-7) However, particles in this size range have potentially cohesive property and tend to disperse poorly.One approach to achieve excellent inhalation delivery by simultaneously improving the micromeritic properties and reducing the cohesive properties of agents is to design spherical particles with relative large geometric diameters and low particle mass densities. Inter-particulate cohesion could be reduced by enlarging and spheronizing the individual particle, and aerosol performance could be improved by decreasing the weight of the particles, ultimately like soap bubbles. In particular, particle design focused on particle density has been specifically resear...

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Regular treatment with formoterol for chronic asthma: serious adverse events

Cates

Lasserson

2008

Cochrane Database of Systematic Reviews

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In comparison with placebo, we have found an increased risk of serious adverse events with regular formoterol, and this does not appear to be abolished in patients taking inhaled corticosteroids. The effect on serious adverse events of regular formoterol in children was greater than the effect in adults, but the difference between age-groups was not significant.Data on all-cause serious adverse events should be more fully reported in journal articles, and not combined with all adverse events or limited to those events that are thought by the investigator to be drug-related.

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Efficacy and safety of formoterol delivered through the Novolizer®, a novel dry powder inhaler (DPI) compared with a standard DPI in patients with moderate to severe asthma

Cited by 9 publications

References 14 publications

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

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

Spray Freeze-Dried Porous Microparticles of a Poorly Water-Soluble Drug for Respiratory Delivery

Regular treatment with formoterol for chronic asthma: serious adverse events

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