Professional Slides: Performance data

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This study used a video camera to compare the spray durations of aerosol clouds delivered via Respimat® SMI with those from a variety of CFC- and HFA-MDIs. The formulations in all of the CFC-MDIs and for salmeterol + fluticasone via HFA-MDI were suspensions. The formulations in all of the other HFA-MDIs and in Respimat® SMI were solutions.

Aerosol clouds generated via Respimat® SMI last considerably longer than those delivered by either CFC- or HFA-MDIs.

The Soft Mist™ characteristic of the aerosol cloud generated by Respimat® SMI results in improved lung and reduced oropharyngeal deposition compared with other devices.

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This study used a video camera to compare the velocities of aerosol clouds delivered via Respimat® SMI with those from a variety of CFC- and HFA-MDIs. The formulations in all of the CFC-MDIs and for salmeterol + fluticasone via HFA-MDI were suspensions. The formulations in all of the other HFA-MDIs and in Respimat® SMI were solutions.

Aerosol clouds generated via Respimat® SMI are considerably slower moving than those delivered by either CFC- or HFA-MDIs.

The Soft Mist™ characteristic of the aerosol cloud generated by Respimat® SMI results in improved lung and reduced oropharyngeal deposition compared with other devices.

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A high proportion of the droplets in the cloud from Respimat® SMI fall into the FPF (droplets of ≦5.8 µm in diameter).

Such particles are small enough to penetrate into, and be absorbed by, the lungs after inhalation. Respimat® SMI performance studies analysed particle size distribution in an Andersen cascade impactor, using an aqueous solution of fenoterol.

The results showed a FPF of approximately 66% for the aqueous formulation. This value is considerably higher than that released from a CFC-MDI.

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A high proportion of the droplets in the cloud from Respimat® SMI fall into the FPF (droplets of =<5.8 µm in diameter). Such particles are small enough to penetrate into, and be absorbed by, the lungs after inhalation. Respimat® SMI performance studies analysed particle size distribution in an Andersen cascade impactor, using an ethanolic solution of flunisolide. The results showed a FPF of approximately 81% for the ethanolic formulation. This value is considerably higher than that released from a CFC-MDI.

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A randomised three-way crossover study in 12 healthy volunteers compared lung deposition of radiolabelled fenoterol delivered via Respimat® SMI or conventional pMDI with or without a spacer.

Deposition of fenoterol in the lung and oropharynx was measured using gamma scintigraphy. Deposition of fenoterol in the device was also measured.

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Respimat® SMI delivered significantly more fenoterol to the lungs than either a pMDI alone or a pMDI + spacer (39.2% vs 11.0% vs 9.9% of metered dose, respectively; p<0.01).

Oropharyngeal deposition of fenoterol was significantly lower than that from the pMDI (37.1% vs 71.7%, respectively; p<0.01). The use of the pMDI plus spacer reduced mean oropharyngeal deposition to 3.6%.

The high lung deposition and low oropharyngeal deposition with Respimat® SMI may improve efficacy and tolerability of inhaled medications.

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A randomised crossover study in 12 healthy volunteers compared lung deposition of radiolabelled flunisolide delivered via Respimat® SMI or conventional pMDI with an Inhacort® spacer.

Deposition of flunisolide in the lung and oropharynx was measured using gamma scintigraphy.

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Respimat® SMI deposited significantly more flunisolide in the lungs than did pMDI + spacer (44.6% vs 26.4%, respectively; p<0.01).

The high lung deposition and low oropharyngeal deposition with Respimat® SMI may improve efficacy and tolerability of inhaled medications.

Ethanolic formulations, such as flunisolide, result in greater lung deposition than aqueous formulations, such as fenoterol, because they generate a higher FPF. Consequently, oropharyngeal deposition is lower with ethanolic formulations than with aqueous formulations.

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Twelve asthmatic patients completed a randomised crossover study to determine the lung deposition of budesonide 200 µg inhaled from either Respimat® SMI or multi-dose DPI (MDPI) (Turbuhaler®) - inhaled at fast and slow inspiratory flow rates.

Lung and oropharyngeal deposition were measured using gamma scintigraphy.

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Whole lung deposition of budesonide delivered via Respimat® SMI was considerably greater than that from the MDPI (Turbuhaler®), inhaled at both fast and slow inspiratory flow rates (51.2% vs 28.9% and 18.1%, respectively).

The results of this study suggest that Respimat® SMI is superior to the MDPI (Turbuhaler®) for delivering drugs to the lungs.

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The development of new devices, such as Respimat® SMI, requires efficient testing of aerosol parameters. Among the parameters, particle size distribution is important, as it defines the inhalable fraction of the aerosol.

A high proportion of the droplets in the aerosol cloud from Respimat® SMI fall into the FPF (droplets of =5.8 µm in diameter); such particles are small enough to penetrate into, and be absorbed by, the lungs after inhalation.

The high FPF and the slow velocity of the cloud generated by Respimat® SMI enable more of the emitted dose to reach the airways and less to be lost by oropharyngeal impaction compared with pMDIs; this has been confirmed in two scintigraphic studies (Newman et al. 1996, 1998).

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In this study of 10 healthy volunteers, the deposition pattern in the lungs and oropharynx of an ethanolic solution of flunisolide delivered via Respimat® SMI, pMDI or pMDI + spacer was determined by gamma scintigraphy.

Oropharyngeal deposition was significantly reduced with Respimat® SMI compared with the pMDI (39.9% vs 66.9%, respectively; p<0.01).

The distribution of aerosol on the walls of the spacer can be seen in the scan on the right.