I need an interpreter, please- for this Pulmozyme study

[AnD]

Sorry, it's long, but can someone tell me if this actually says it is okay to use with Pulmozyme, or at least pull out the important parts that I need to be comparing, say, to the eFlow or the Pari LC Plus?

1
INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
August 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 ?calculation ________________________________________________________________ 3
2.2.3 Rhdnase mass calculation____________________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Inhaled mass __________________________________________________________ 7
3.2 Nebulization time_______________________________________________________ 7
3.3 MMAD_________________________________________________________________ 7
4. Conclusion ________________________________________________________ 8
References________________________________________________________________ 9
3
1. Study Objective
The objective of this study was to measure the inhalable mass and the particle
size of Pulmozyme® (Roche, Neuilly sur seine, France) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).

<div class="FTQUOTE"><begin quote>2. Measurement method
The experimental set up defined by EN13544-1 European standard and the
mass measurement method defined in the article (2) were used in this study.</end quote></div>

2.1 Tested Materials
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Pulmozyme® 2.5mg/2.5ml (Roche, Neuilly sur seine, France) Batch B1307

<b>2.2 Inhaled Mass (IM)</b>2.2.1 Experimental setup (Figure 1)
Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for Pulmozyme® collection was positioned between the nebulizer and
the piston pump (Harvard, USA). Filters were changed every 5 minutes until the
end of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.

<b>2.2.2 ?calculation</b>
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
4
The relative mass of the RhDnase (?) in total solute mass (drug +
excipients=Pulmozyme®) collected on the filters was measured as follows. 3
Pari filters (Pari filter, Pari, Germany) were weighed. 1 mg of RhDnase (1 ml of
the Pulmozyme® at a concentration of 1mg/ml) was placed with a pipette onto
each of three Pari filters. All filters were dried in the scale room during a 24-hour
period. The difference between the weight of each filter after solution pipetting
and drying and its weight before pipetting was calculated (?). The value of ?was
calculated by determining the ratio between the RhDnase mass deposited on
the filter (1 mg for RhDnase) and ?(?= 1 mg/ ?)

<b>2.2.3 Rhdnase mass calculation</b>
The nebulized Pulmozyme® mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Pulmozyme mass).
The RhDnase mass was calculated as the product of Pulmozyme® mass
mass and the proportion of RhDnase contained in Pulmozyme® mass (Rhdnase
mass = Pulmozyme® mass X ?).

<b>2.3 Particle size measurement </b>(Figure 2)
To determine the particle size of the Pulmozyme aerosol produced by the
Aeroneb Go nebulizer, we used a device that takes measurements by means
of the laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).

5
Figure 1 : Experimental set up for inhaled mass measurement
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
Figure 2 : Particle size measurement set-up
7
<div class="FTQUOTE"><begin quote><u><b>3. Results</b></u>
<b>3.1 Inhaled mass</b>
Nebulizer .........................RhDnase Inhaled mass (µg)
Aeroneb Go 1a.....................857
Aeroneb Go 1b ....................815
Aeroneb Go 2a.....................832
Aeroneb Go 2b.................... 806
Aeroneb Go 3a.................... 822
Aeroneb Go 3b ....................657
mean .................................798
standard deviation................ 71
Table 1 : RhDnase inhaled mass results</end quote></div>

<div class="FTQUOTE"><begin quote>3.2 Nebulization time...................Nebulizer Nebulization time (min)
Aeroneb Go 1a................................ 4.1
Aeroneb Go 1b................................ 3.8
Aeroneb Go 2a................................ 4.8
Aeroneb Go 2b................................ 5.1
Aeroneb Go 3a................................ 4.3
Aeroneb Go 3b................................ 4.2
mean............................................. 4.4
standard deviation.......................... 0.5
Table 2 : Nebulization time results</end quote></div>

<div class="FTQUOTE"><begin quote>3.3 MMAD
Nebulizer................... MMAD (µm)
Aeroneb Go 1a............. 5.0
Aeroneb Go 1b............. 5.1
Aeroneb Go 2a .............4.3
Aeroneb Go 2b............. 4.1
Aeroneb Go 3a .............4.4
Aeroneb Go 3b............. 4.2
mean ..........................4.5
standard deviation........ 0.4
Table 3 : Mass Median Aerodynamic Diameter (MMAD) results</end quote></div>
8

<div class="FTQUOTE"><begin quote><b>4. Conclusion</b>
The RhDnase inhaled mass of the nebulized Pulmozyme® (2500µg/2.5ml)
with the Aeroneb Go® nebulizer was 798µg ± 71µg.
The Mass Median Aerodynamic Diameter (MMAD) of the Pulmozyme®
nebulized by Aeroneb Go® was 4.5µm ± 0.4µm.
The duration to nebulize the Pulmozyme® with Aeroneb Go® was 4.4min ±
0.5min.</end quote></div>

9
References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
10
Tours, 2006/08/30
Laurent Vecellio

 

[AnD]

Sorry, it's long, but can someone tell me if this actually says it is okay to use with Pulmozyme, or at least pull out the important parts that I need to be comparing, say, to the eFlow or the Pari LC Plus?

1
INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
August 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 ?calculation ________________________________________________________________ 3
2.2.3 Rhdnase mass calculation____________________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Inhaled mass __________________________________________________________ 7
3.2 Nebulization time_______________________________________________________ 7
3.3 MMAD_________________________________________________________________ 7
4. Conclusion ________________________________________________________ 8
References________________________________________________________________ 9
3
1. Study Objective
The objective of this study was to measure the inhalable mass and the particle
size of Pulmozyme® (Roche, Neuilly sur seine, France) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).

<div class="FTQUOTE"><begin quote>2. Measurement method
The experimental set up defined by EN13544-1 European standard and the
mass measurement method defined in the article (2) were used in this study.</end quote></div>

2.1 Tested Materials
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Pulmozyme® 2.5mg/2.5ml (Roche, Neuilly sur seine, France) Batch B1307

<b>2.2 Inhaled Mass (IM)</b>2.2.1 Experimental setup (Figure 1)
Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for Pulmozyme® collection was positioned between the nebulizer and
the piston pump (Harvard, USA). Filters were changed every 5 minutes until the
end of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.

<b>2.2.2 ?calculation</b>
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
4
The relative mass of the RhDnase (?) in total solute mass (drug +
excipients=Pulmozyme®) collected on the filters was measured as follows. 3
Pari filters (Pari filter, Pari, Germany) were weighed. 1 mg of RhDnase (1 ml of
the Pulmozyme® at a concentration of 1mg/ml) was placed with a pipette onto
each of three Pari filters. All filters were dried in the scale room during a 24-hour
period. The difference between the weight of each filter after solution pipetting
and drying and its weight before pipetting was calculated (?). The value of ?was
calculated by determining the ratio between the RhDnase mass deposited on
the filter (1 mg for RhDnase) and ?(?= 1 mg/ ?)

<b>2.2.3 Rhdnase mass calculation</b>
The nebulized Pulmozyme® mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Pulmozyme mass).
The RhDnase mass was calculated as the product of Pulmozyme® mass
mass and the proportion of RhDnase contained in Pulmozyme® mass (Rhdnase
mass = Pulmozyme® mass X ?).

<b>2.3 Particle size measurement </b>(Figure 2)
To determine the particle size of the Pulmozyme aerosol produced by the
Aeroneb Go nebulizer, we used a device that takes measurements by means
of the laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).

5
Figure 1 : Experimental set up for inhaled mass measurement
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
Figure 2 : Particle size measurement set-up
7
<div class="FTQUOTE"><begin quote><u><b>3. Results</b></u>
<b>3.1 Inhaled mass</b>
Nebulizer .........................RhDnase Inhaled mass (µg)
Aeroneb Go 1a.....................857
Aeroneb Go 1b ....................815
Aeroneb Go 2a.....................832
Aeroneb Go 2b.................... 806
Aeroneb Go 3a.................... 822
Aeroneb Go 3b ....................657
mean .................................798
standard deviation................ 71
Table 1 : RhDnase inhaled mass results</end quote></div>

<div class="FTQUOTE"><begin quote>3.2 Nebulization time...................Nebulizer Nebulization time (min)
Aeroneb Go 1a................................ 4.1
Aeroneb Go 1b................................ 3.8
Aeroneb Go 2a................................ 4.8
Aeroneb Go 2b................................ 5.1
Aeroneb Go 3a................................ 4.3
Aeroneb Go 3b................................ 4.2
mean............................................. 4.4
standard deviation.......................... 0.5
Table 2 : Nebulization time results</end quote></div>

<div class="FTQUOTE"><begin quote>3.3 MMAD
Nebulizer................... MMAD (µm)
Aeroneb Go 1a............. 5.0
Aeroneb Go 1b............. 5.1
Aeroneb Go 2a .............4.3
Aeroneb Go 2b............. 4.1
Aeroneb Go 3a .............4.4
Aeroneb Go 3b............. 4.2
mean ..........................4.5
standard deviation........ 0.4
Table 3 : Mass Median Aerodynamic Diameter (MMAD) results</end quote></div>
8

<div class="FTQUOTE"><begin quote><b>4. Conclusion</b>
The RhDnase inhaled mass of the nebulized Pulmozyme® (2500µg/2.5ml)
with the Aeroneb Go® nebulizer was 798µg ± 71µg.
The Mass Median Aerodynamic Diameter (MMAD) of the Pulmozyme®
nebulized by Aeroneb Go® was 4.5µm ± 0.4µm.
The duration to nebulize the Pulmozyme® with Aeroneb Go® was 4.4min ±
0.5min.</end quote></div>

9
References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
10
Tours, 2006/08/30
Laurent Vecellio

 

[AnD]

Sorry, it's long, but can someone tell me if this actually says it is okay to use with Pulmozyme, or at least pull out the important parts that I need to be comparing, say, to the eFlow or the Pari LC Plus?

1
INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
August 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 ?calculation ________________________________________________________________ 3
2.2.3 Rhdnase mass calculation____________________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Inhaled mass __________________________________________________________ 7
3.2 Nebulization time_______________________________________________________ 7
3.3 MMAD_________________________________________________________________ 7
4. Conclusion ________________________________________________________ 8
References________________________________________________________________ 9
3
1. Study Objective
The objective of this study was to measure the inhalable mass and the particle
size of Pulmozyme® (Roche, Neuilly sur seine, France) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).

<div class="FTQUOTE"><begin quote>2. Measurement method
The experimental set up defined by EN13544-1 European standard and the
mass measurement method defined in the article (2) were used in this study.</end quote></div>

2.1 Tested Materials
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Pulmozyme® 2.5mg/2.5ml (Roche, Neuilly sur seine, France) Batch B1307

<b>2.2 Inhaled Mass (IM)</b>2.2.1 Experimental setup (Figure 1)
Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for Pulmozyme® collection was positioned between the nebulizer and
the piston pump (Harvard, USA). Filters were changed every 5 minutes until the
end of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.

<b>2.2.2 ?calculation</b>
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
4
The relative mass of the RhDnase (?) in total solute mass (drug +
excipients=Pulmozyme®) collected on the filters was measured as follows. 3
Pari filters (Pari filter, Pari, Germany) were weighed. 1 mg of RhDnase (1 ml of
the Pulmozyme® at a concentration of 1mg/ml) was placed with a pipette onto
each of three Pari filters. All filters were dried in the scale room during a 24-hour
period. The difference between the weight of each filter after solution pipetting
and drying and its weight before pipetting was calculated (?). The value of ?was
calculated by determining the ratio between the RhDnase mass deposited on
the filter (1 mg for RhDnase) and ?(?= 1 mg/ ?)

<b>2.2.3 Rhdnase mass calculation</b>
The nebulized Pulmozyme® mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Pulmozyme mass).
The RhDnase mass was calculated as the product of Pulmozyme® mass
mass and the proportion of RhDnase contained in Pulmozyme® mass (Rhdnase
mass = Pulmozyme® mass X ?).

<b>2.3 Particle size measurement </b>(Figure 2)
To determine the particle size of the Pulmozyme aerosol produced by the
Aeroneb Go nebulizer, we used a device that takes measurements by means
of the laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).

5
Figure 1 : Experimental set up for inhaled mass measurement
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
Figure 2 : Particle size measurement set-up
7
<div class="FTQUOTE"><begin quote><u><b>3. Results</b></u>
<b>3.1 Inhaled mass</b>
Nebulizer .........................RhDnase Inhaled mass (µg)
Aeroneb Go 1a.....................857
Aeroneb Go 1b ....................815
Aeroneb Go 2a.....................832
Aeroneb Go 2b.................... 806
Aeroneb Go 3a.................... 822
Aeroneb Go 3b ....................657
mean .................................798
standard deviation................ 71
Table 1 : RhDnase inhaled mass results</end quote></div>

<div class="FTQUOTE"><begin quote>3.2 Nebulization time...................Nebulizer Nebulization time (min)
Aeroneb Go 1a................................ 4.1
Aeroneb Go 1b................................ 3.8
Aeroneb Go 2a................................ 4.8
Aeroneb Go 2b................................ 5.1
Aeroneb Go 3a................................ 4.3
Aeroneb Go 3b................................ 4.2
mean............................................. 4.4
standard deviation.......................... 0.5
Table 2 : Nebulization time results</end quote></div>

<div class="FTQUOTE"><begin quote>3.3 MMAD
Nebulizer................... MMAD (µm)
Aeroneb Go 1a............. 5.0
Aeroneb Go 1b............. 5.1
Aeroneb Go 2a .............4.3
Aeroneb Go 2b............. 4.1
Aeroneb Go 3a .............4.4
Aeroneb Go 3b............. 4.2
mean ..........................4.5
standard deviation........ 0.4
Table 3 : Mass Median Aerodynamic Diameter (MMAD) results</end quote></div>
8

<div class="FTQUOTE"><begin quote><b>4. Conclusion</b>
The RhDnase inhaled mass of the nebulized Pulmozyme® (2500µg/2.5ml)
with the Aeroneb Go® nebulizer was 798µg ± 71µg.
The Mass Median Aerodynamic Diameter (MMAD) of the Pulmozyme®
nebulized by Aeroneb Go® was 4.5µm ± 0.4µm.
The duration to nebulize the Pulmozyme® with Aeroneb Go® was 4.4min ±
0.5min.</end quote></div>

9
References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
10
Tours, 2006/08/30
Laurent Vecellio

 

[AnD]

Sorry, it's long, but can someone tell me if this actually says it is okay to use with Pulmozyme, or at least pull out the important parts that I need to be comparing, say, to the eFlow or the Pari LC Plus?

1
INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
August 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 ?calculation ________________________________________________________________ 3
2.2.3 Rhdnase mass calculation____________________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Inhaled mass __________________________________________________________ 7
3.2 Nebulization time_______________________________________________________ 7
3.3 MMAD_________________________________________________________________ 7
4. Conclusion ________________________________________________________ 8
References________________________________________________________________ 9
3
1. Study Objective
The objective of this study was to measure the inhalable mass and the particle
size of Pulmozyme® (Roche, Neuilly sur seine, France) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).

<div class="FTQUOTE"><begin quote>2. Measurement method
The experimental set up defined by EN13544-1 European standard and the
mass measurement method defined in the article (2) were used in this study.</end quote>

2.1 Tested Materials
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Pulmozyme® 2.5mg/2.5ml (Roche, Neuilly sur seine, France) Batch B1307

<b>2.2 Inhaled Mass (IM)</b>2.2.1 Experimental setup (Figure 1)
Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for Pulmozyme® collection was positioned between the nebulizer and
the piston pump (Harvard, USA). Filters were changed every 5 minutes until the
end of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.

<b>2.2.2 ?calculation</b>
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
4
The relative mass of the RhDnase (?) in total solute mass (drug +
excipients=Pulmozyme®) collected on the filters was measured as follows. 3
Pari filters (Pari filter, Pari, Germany) were weighed. 1 mg of RhDnase (1 ml of
the Pulmozyme® at a concentration of 1mg/ml) was placed with a pipette onto
each of three Pari filters. All filters were dried in the scale room during a 24-hour
period. The difference between the weight of each filter after solution pipetting
and drying and its weight before pipetting was calculated (?). The value of ?was
calculated by determining the ratio between the RhDnase mass deposited on
the filter (1 mg for RhDnase) and ?(?= 1 mg/ ?)

<b>2.2.3 Rhdnase mass calculation</b>
The nebulized Pulmozyme® mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Pulmozyme mass).
The RhDnase mass was calculated as the product of Pulmozyme® mass
mass and the proportion of RhDnase contained in Pulmozyme® mass (Rhdnase
mass = Pulmozyme® mass X ?).

<b>2.3 Particle size measurement </b>(Figure 2)
To determine the particle size of the Pulmozyme aerosol produced by the
Aeroneb Go nebulizer, we used a device that takes measurements by means
of the laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).

5
Figure 1 : Experimental set up for inhaled mass measurement
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
Figure 2 : Particle size measurement set-up
7
<div class="FTQUOTE"><begin quote><u><b>3. Results</b></u>
<b>3.1 Inhaled mass</b>
Nebulizer .........................RhDnase Inhaled mass (µg)
Aeroneb Go 1a.....................857
Aeroneb Go 1b ....................815
Aeroneb Go 2a.....................832
Aeroneb Go 2b.................... 806
Aeroneb Go 3a.................... 822
Aeroneb Go 3b ....................657
mean .................................798
standard deviation................ 71
Table 1 : RhDnase inhaled mass results</end quote>

<div class="FTQUOTE"><begin quote>3.2 Nebulization time...................Nebulizer Nebulization time (min)
Aeroneb Go 1a................................ 4.1
Aeroneb Go 1b................................ 3.8
Aeroneb Go 2a................................ 4.8
Aeroneb Go 2b................................ 5.1
Aeroneb Go 3a................................ 4.3
Aeroneb Go 3b................................ 4.2
mean............................................. 4.4
standard deviation.......................... 0.5
Table 2 : Nebulization time results</end quote>

<div class="FTQUOTE"><begin quote>3.3 MMAD
Nebulizer................... MMAD (µm)
Aeroneb Go 1a............. 5.0
Aeroneb Go 1b............. 5.1
Aeroneb Go 2a .............4.3
Aeroneb Go 2b............. 4.1
Aeroneb Go 3a .............4.4
Aeroneb Go 3b............. 4.2
mean ..........................4.5
standard deviation........ 0.4
Table 3 : Mass Median Aerodynamic Diameter (MMAD) results</end quote>
8

<div class="FTQUOTE"><begin quote><b>4. Conclusion</b>
The RhDnase inhaled mass of the nebulized Pulmozyme® (2500µg/2.5ml)
with the Aeroneb Go® nebulizer was 798µg ± 71µg.
The Mass Median Aerodynamic Diameter (MMAD) of the Pulmozyme®
nebulized by Aeroneb Go® was 4.5µm ± 0.4µm.
The duration to nebulize the Pulmozyme® with Aeroneb Go® was 4.4min ±
0.5min.</end quote>

9
References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
10
Tours, 2006/08/30
Laurent Vecellio

 

[AnD]

Sorry, it's long, but can someone tell me if this actually says it is okay to use with Pulmozyme, or at least pull out the important parts that I need to be comparing, say, to the eFlow or the Pari LC Plus?

1
INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
August 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 ?calculation ________________________________________________________________ 3
2.2.3 Rhdnase mass calculation____________________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Inhaled mass __________________________________________________________ 7
3.2 Nebulization time_______________________________________________________ 7
3.3 MMAD_________________________________________________________________ 7
4. Conclusion ________________________________________________________ 8
References________________________________________________________________ 9
3
1. Study Objective
The objective of this study was to measure the inhalable mass and the particle
size of Pulmozyme® (Roche, Neuilly sur seine, France) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).

<div class="FTQUOTE"><begin quote>2. Measurement method
The experimental set up defined by EN13544-1 European standard and the
mass measurement method defined in the article (2) were used in this study.</end quote>

2.1 Tested Materials
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Pulmozyme® 2.5mg/2.5ml (Roche, Neuilly sur seine, France) Batch B1307

<b>2.2 Inhaled Mass (IM)</b>2.2.1 Experimental setup (Figure 1)
Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for Pulmozyme® collection was positioned between the nebulizer and
the piston pump (Harvard, USA). Filters were changed every 5 minutes until the
end of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.

<b>2.2.2 ?calculation</b>
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
4
The relative mass of the RhDnase (?) in total solute mass (drug +
excipients=Pulmozyme®) collected on the filters was measured as follows. 3
Pari filters (Pari filter, Pari, Germany) were weighed. 1 mg of RhDnase (1 ml of
the Pulmozyme® at a concentration of 1mg/ml) was placed with a pipette onto
each of three Pari filters. All filters were dried in the scale room during a 24-hour
period. The difference between the weight of each filter after solution pipetting
and drying and its weight before pipetting was calculated (?). The value of ?was
calculated by determining the ratio between the RhDnase mass deposited on
the filter (1 mg for RhDnase) and ?(?= 1 mg/ ?)

<b>2.2.3 Rhdnase mass calculation</b>
The nebulized Pulmozyme® mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Pulmozyme mass).
The RhDnase mass was calculated as the product of Pulmozyme® mass
mass and the proportion of RhDnase contained in Pulmozyme® mass (Rhdnase
mass = Pulmozyme® mass X ?).

<b>2.3 Particle size measurement </b>(Figure 2)
To determine the particle size of the Pulmozyme aerosol produced by the
Aeroneb Go nebulizer, we used a device that takes measurements by means
of the laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).

5
Figure 1 : Experimental set up for inhaled mass measurement
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
Figure 2 : Particle size measurement set-up
7
<div class="FTQUOTE"><begin quote><u><b>3. Results</b></u>
<b>3.1 Inhaled mass</b>
Nebulizer .........................RhDnase Inhaled mass (µg)
Aeroneb Go 1a.....................857
Aeroneb Go 1b ....................815
Aeroneb Go 2a.....................832
Aeroneb Go 2b.................... 806
Aeroneb Go 3a.................... 822
Aeroneb Go 3b ....................657
mean .................................798
standard deviation................ 71
Table 1 : RhDnase inhaled mass results</end quote>

<div class="FTQUOTE"><begin quote>3.2 Nebulization time...................Nebulizer Nebulization time (min)
Aeroneb Go 1a................................ 4.1
Aeroneb Go 1b................................ 3.8
Aeroneb Go 2a................................ 4.8
Aeroneb Go 2b................................ 5.1
Aeroneb Go 3a................................ 4.3
Aeroneb Go 3b................................ 4.2
mean............................................. 4.4
standard deviation.......................... 0.5
Table 2 : Nebulization time results</end quote>

<div class="FTQUOTE"><begin quote>3.3 MMAD
Nebulizer................... MMAD (µm)
Aeroneb Go 1a............. 5.0
Aeroneb Go 1b............. 5.1
Aeroneb Go 2a .............4.3
Aeroneb Go 2b............. 4.1
Aeroneb Go 3a .............4.4
Aeroneb Go 3b............. 4.2
mean ..........................4.5
standard deviation........ 0.4
Table 3 : Mass Median Aerodynamic Diameter (MMAD) results</end quote>
8

<div class="FTQUOTE"><begin quote><b>4. Conclusion</b>
The RhDnase inhaled mass of the nebulized Pulmozyme® (2500µg/2.5ml)
with the Aeroneb Go® nebulizer was 798µg ± 71µg.
The Mass Median Aerodynamic Diameter (MMAD) of the Pulmozyme®
nebulized by Aeroneb Go® was 4.5µm ± 0.4µm.
The duration to nebulize the Pulmozyme® with Aeroneb Go® was 4.4min ±
0.5min.</end quote>

9
References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
10
Tours, 2006/08/30
Laurent Vecellio

 

[AnD]

And this one?

1
<b>EVALUATION OF THE AERONEB GO® NEBULIZER
PERFORMANCES WITH ATROVENT® (0.5mg/2ml),
BRICANYL® (5mg/2ml), VENTOLINE® (5mg/2.5ml)
AND TOBI® (300mg/5ml)
STUDY REPORT</b>

INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
September 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 t calculation ________________________________________________________________ 3
2.2.3 Active compound mass calculation ____________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Atrovent® (0.5mg/2ml) __________________________________________________ 7
3.2 Bricanyl® (5mg/2ml) ____________________________________________________ 7
3.3 Ventoline® (5mg/2.5ml) _________________________________________________ 8
3.4 Tobi® (300mg/5ml) _____________________________________________________ 8
4. Conclusion ________________________________________________________ 9
References_______________________________________________________________ 10
3
1. Study Objective
The objective of this study was to measure the inhaled mass and the particle size
of different drugs (Atrovent®, Bricanyl®, Ventoline®, Tobi®) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).
<b>2. Measurement method</b>
The experimental set up defined by EN13544-1 European standard and the
mass measurement methods defined in the article (2) were used in this
study.
<b>2.1 Tested Materials</b>
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Atrovent® 0.5mg/2ml (Boehringer Ingelheim, France) Batch 238224
- Bricanyl® 5mg/2ml (Astra Zeneca, Suède) Batch HC1518
- Ventoline® 5mg/2.5ml (GlaxoSmithKline) Batch G7278
- Tobi® 300mg/5ml (Chiron, USA)


<b>2.2 Inhaled Mass (IM)</b>

<b>2.2.1 Experimental setup </b>(Figure 1)

Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for drug collection was positioned between the nebulizer and the
piston pump (Harvard, USA). Filters were changed every 5 minutes until the end
of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.
2.2.2 t calculation
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
4
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
The relative mass of the active compound (t) (ipratropium bromide for
Atrovent®, terbutaline for Bricanyl®, salbutamol for Ventoline® and tobramycin
for Tobi®) in total solute mass (active compound + excipients=drug) collected on
the filters was measured as follows. 3 Pari filters (Pari filter, Pari, Germany) were
weighed for each drug. 0.25 mg of ipratropium bromide (1 ml of the Atrovent®
at a concentration of 0.25mg/ml) was placed with a pipette onto each of three
Pari filters. 2.5 mg of terbutaline (1 ml of the Bricanyl® at a concentration of
2.5mg/ml) was placed with a pipette onto each of three Pari filters. 2 mg of
salbutamol (1 ml of the Ventoline® at a concentration of 2 mg/ml) was placed
with a pipette onto each of three Pari filters. 60 mg of tobramycine (1 ml of the
Tobi® at a concentration of 50mg/ml) was placed with a pipette onto each of
three Pari filters. All filters were dried in the scale room during a 24-hour period.
The difference between the weight of each filter after solution pipetting and
drying and its weight before pipetting was calculated (Ddrug). The value of
tactivecompound was calculated by determining the ratio between the active
compound mass deposited on the filter and D drug.

<b>2.2.3 Active compound mass calculation</b>

The nebulized drug mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Ddrug).
The active compound mass was calculated as the product of drug mass
and the proportion of active compound mass contained in drug mass (active
compound mass = D drug X tactivecompound).


<b>2.3 Particle size measurement (Figure 2)</b>

To determine the particle size of the aerosol drug produced by the Aeroneb
Go nebulizer, we used a device that takes measurements by means of the
laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).
5
<u>Figure 1 : Experimental set up for inhaled mass measurement</u>
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
<i>Figure 2 : Particle size measurement set-up</i>
7
<div class="FTQUOTE"><begin quote><b>3. Results</b>

{I only included the chart for Tobi here}

<b><i>3.4 Tobi® (300mg/5ml)</i></b>

Nebulizer....tobramycine inhaled mass....MMAD.....Nebulization time
()...........................mg..............................(µm)............(min)

Aeroneb Go 1a .....109................................ 3.3 ..............14
Aeroneb Go 1b..... 103 ............................... 3.8 ..............16
Aeroneb Go 2a .... 106................................ 4.2 ..............21
Aeroneb Go 2b..... 105 ................................3.7.............. 10
Aeroneb Go 3a..... 113................................ 3.8 ............. 15
Aeroneb Go 3b .....110 ................................3.2 ..............14
mean ...................108 ................................3.7 ............ 15
standard deviation ....4 ................................0.4 ................4
Table 4 : inhaled mass, nebulization time and MMAD results for Tobi®</end quote></div>
9
<b>4. Conclusion</b>
The bromide ipratropium inhaled mass of the nebulized Atrovent®
(0.5mg/2ml) with the Aeroneb Go® nebulizer was 0.17mg ± 0.02mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Atrovent® nebulized
by Aeroneb Go® was 4.4µm ± 0.1µm.
The duration to nebulize the Atrovent® with Aeroneb Go® was 4min ± 1min.
The terbutaline inhaled mass of the nebulized Bricanyl® (5mg/2ml) with the
Aeroneb Go® nebulizer was 1.7mg ± 0.3g.
The Mass Median Aerodynamic Diameter (MMAD) of the Bricanyl® nebulized
by Aeroneb Go® was 4.8µm ± 0.1µm.
The duration to nebulize the Bricanyl® with Aeroneb Go® was 4min ± 0.5min.
The salbutamol inhaled mass of the nebulized Ventoline® (5mg/2.5ml) with
the Aeroneb Go® nebulizer was 1.4mg ± 0.2mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Ventoline®
nebulized by Aeroneb Go® was 4.8µm ± 0.2µm.
The duration to nebulize the Ventoline® with Aeroneb Go® was 5min ± 1min.
<div class="FTQUOTE"><begin quote><i><u>The tobramycin inhaled mass of the nebulized Tobi® (300mg/5ml) with the
Aeroneb Go® nebulizer was 108mg ± 4mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Tobi® nebulized by
Aeroneb Go® was 3.7µm ± 0.4µm.
The duration to nebulize the Tobi® with Aeroneb Go® was 15min ± 3min.
10</u></i></end quote></div>

References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
11
Tours, 2006/09/13
Laurent Vecellio

 

[AnD]

And this one?

1
<b>EVALUATION OF THE AERONEB GO® NEBULIZER
PERFORMANCES WITH ATROVENT® (0.5mg/2ml),
BRICANYL® (5mg/2ml), VENTOLINE® (5mg/2.5ml)
AND TOBI® (300mg/5ml)
STUDY REPORT</b>

INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
September 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 t calculation ________________________________________________________________ 3
2.2.3 Active compound mass calculation ____________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Atrovent® (0.5mg/2ml) __________________________________________________ 7
3.2 Bricanyl® (5mg/2ml) ____________________________________________________ 7
3.3 Ventoline® (5mg/2.5ml) _________________________________________________ 8
3.4 Tobi® (300mg/5ml) _____________________________________________________ 8
4. Conclusion ________________________________________________________ 9
References_______________________________________________________________ 10
3
1. Study Objective
The objective of this study was to measure the inhaled mass and the particle size
of different drugs (Atrovent®, Bricanyl®, Ventoline®, Tobi®) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).
<b>2. Measurement method</b>
The experimental set up defined by EN13544-1 European standard and the
mass measurement methods defined in the article (2) were used in this
study.
<b>2.1 Tested Materials</b>
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Atrovent® 0.5mg/2ml (Boehringer Ingelheim, France) Batch 238224
- Bricanyl® 5mg/2ml (Astra Zeneca, Suède) Batch HC1518
- Ventoline® 5mg/2.5ml (GlaxoSmithKline) Batch G7278
- Tobi® 300mg/5ml (Chiron, USA)


<b>2.2 Inhaled Mass (IM)</b>

<b>2.2.1 Experimental setup </b>(Figure 1)

Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for drug collection was positioned between the nebulizer and the
piston pump (Harvard, USA). Filters were changed every 5 minutes until the end
of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.
2.2.2 t calculation
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
4
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
The relative mass of the active compound (t) (ipratropium bromide for
Atrovent®, terbutaline for Bricanyl®, salbutamol for Ventoline® and tobramycin
for Tobi®) in total solute mass (active compound + excipients=drug) collected on
the filters was measured as follows. 3 Pari filters (Pari filter, Pari, Germany) were
weighed for each drug. 0.25 mg of ipratropium bromide (1 ml of the Atrovent®
at a concentration of 0.25mg/ml) was placed with a pipette onto each of three
Pari filters. 2.5 mg of terbutaline (1 ml of the Bricanyl® at a concentration of
2.5mg/ml) was placed with a pipette onto each of three Pari filters. 2 mg of
salbutamol (1 ml of the Ventoline® at a concentration of 2 mg/ml) was placed
with a pipette onto each of three Pari filters. 60 mg of tobramycine (1 ml of the
Tobi® at a concentration of 50mg/ml) was placed with a pipette onto each of
three Pari filters. All filters were dried in the scale room during a 24-hour period.
The difference between the weight of each filter after solution pipetting and
drying and its weight before pipetting was calculated (Ddrug). The value of
tactivecompound was calculated by determining the ratio between the active
compound mass deposited on the filter and D drug.

<b>2.2.3 Active compound mass calculation</b>

The nebulized drug mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Ddrug).
The active compound mass was calculated as the product of drug mass
and the proportion of active compound mass contained in drug mass (active
compound mass = D drug X tactivecompound).


<b>2.3 Particle size measurement (Figure 2)</b>

To determine the particle size of the aerosol drug produced by the Aeroneb
Go nebulizer, we used a device that takes measurements by means of the
laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).
5
<u>Figure 1 : Experimental set up for inhaled mass measurement</u>
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
<i>Figure 2 : Particle size measurement set-up</i>
7
<div class="FTQUOTE"><begin quote><b>3. Results</b>

{I only included the chart for Tobi here}

<b><i>3.4 Tobi® (300mg/5ml)</i></b>

Nebulizer....tobramycine inhaled mass....MMAD.....Nebulization time
()...........................mg..............................(µm)............(min)

Aeroneb Go 1a .....109................................ 3.3 ..............14
Aeroneb Go 1b..... 103 ............................... 3.8 ..............16
Aeroneb Go 2a .... 106................................ 4.2 ..............21
Aeroneb Go 2b..... 105 ................................3.7.............. 10
Aeroneb Go 3a..... 113................................ 3.8 ............. 15
Aeroneb Go 3b .....110 ................................3.2 ..............14
mean ...................108 ................................3.7 ............ 15
standard deviation ....4 ................................0.4 ................4
Table 4 : inhaled mass, nebulization time and MMAD results for Tobi®</end quote></div>
9
<b>4. Conclusion</b>
The bromide ipratropium inhaled mass of the nebulized Atrovent®
(0.5mg/2ml) with the Aeroneb Go® nebulizer was 0.17mg ± 0.02mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Atrovent® nebulized
by Aeroneb Go® was 4.4µm ± 0.1µm.
The duration to nebulize the Atrovent® with Aeroneb Go® was 4min ± 1min.
The terbutaline inhaled mass of the nebulized Bricanyl® (5mg/2ml) with the
Aeroneb Go® nebulizer was 1.7mg ± 0.3g.
The Mass Median Aerodynamic Diameter (MMAD) of the Bricanyl® nebulized
by Aeroneb Go® was 4.8µm ± 0.1µm.
The duration to nebulize the Bricanyl® with Aeroneb Go® was 4min ± 0.5min.
The salbutamol inhaled mass of the nebulized Ventoline® (5mg/2.5ml) with
the Aeroneb Go® nebulizer was 1.4mg ± 0.2mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Ventoline®
nebulized by Aeroneb Go® was 4.8µm ± 0.2µm.
The duration to nebulize the Ventoline® with Aeroneb Go® was 5min ± 1min.
<div class="FTQUOTE"><begin quote><i><u>The tobramycin inhaled mass of the nebulized Tobi® (300mg/5ml) with the
Aeroneb Go® nebulizer was 108mg ± 4mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Tobi® nebulized by
Aeroneb Go® was 3.7µm ± 0.4µm.
The duration to nebulize the Tobi® with Aeroneb Go® was 15min ± 3min.
10</u></i></end quote></div>

References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
11
Tours, 2006/09/13
Laurent Vecellio

 

[AnD]

And this one?

1
<b>EVALUATION OF THE AERONEB GO® NEBULIZER
PERFORMANCES WITH ATROVENT® (0.5mg/2ml),
BRICANYL® (5mg/2ml), VENTOLINE® (5mg/2.5ml)
AND TOBI® (300mg/5ml)
STUDY REPORT</b>

INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
September 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 t calculation ________________________________________________________________ 3
2.2.3 Active compound mass calculation ____________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Atrovent® (0.5mg/2ml) __________________________________________________ 7
3.2 Bricanyl® (5mg/2ml) ____________________________________________________ 7
3.3 Ventoline® (5mg/2.5ml) _________________________________________________ 8
3.4 Tobi® (300mg/5ml) _____________________________________________________ 8
4. Conclusion ________________________________________________________ 9
References_______________________________________________________________ 10
3
1. Study Objective
The objective of this study was to measure the inhaled mass and the particle size
of different drugs (Atrovent®, Bricanyl®, Ventoline®, Tobi®) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).
<b>2. Measurement method</b>
The experimental set up defined by EN13544-1 European standard and the
mass measurement methods defined in the article (2) were used in this
study.
<b>2.1 Tested Materials</b>
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Atrovent® 0.5mg/2ml (Boehringer Ingelheim, France) Batch 238224
- Bricanyl® 5mg/2ml (Astra Zeneca, Suède) Batch HC1518
- Ventoline® 5mg/2.5ml (GlaxoSmithKline) Batch G7278
- Tobi® 300mg/5ml (Chiron, USA)


<b>2.2 Inhaled Mass (IM)</b>

<b>2.2.1 Experimental setup </b>(Figure 1)

Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for drug collection was positioned between the nebulizer and the
piston pump (Harvard, USA). Filters were changed every 5 minutes until the end
of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.
2.2.2 t calculation
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
4
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
The relative mass of the active compound (t) (ipratropium bromide for
Atrovent®, terbutaline for Bricanyl®, salbutamol for Ventoline® and tobramycin
for Tobi®) in total solute mass (active compound + excipients=drug) collected on
the filters was measured as follows. 3 Pari filters (Pari filter, Pari, Germany) were
weighed for each drug. 0.25 mg of ipratropium bromide (1 ml of the Atrovent®
at a concentration of 0.25mg/ml) was placed with a pipette onto each of three
Pari filters. 2.5 mg of terbutaline (1 ml of the Bricanyl® at a concentration of
2.5mg/ml) was placed with a pipette onto each of three Pari filters. 2 mg of
salbutamol (1 ml of the Ventoline® at a concentration of 2 mg/ml) was placed
with a pipette onto each of three Pari filters. 60 mg of tobramycine (1 ml of the
Tobi® at a concentration of 50mg/ml) was placed with a pipette onto each of
three Pari filters. All filters were dried in the scale room during a 24-hour period.
The difference between the weight of each filter after solution pipetting and
drying and its weight before pipetting was calculated (Ddrug). The value of
tactivecompound was calculated by determining the ratio between the active
compound mass deposited on the filter and D drug.

<b>2.2.3 Active compound mass calculation</b>

The nebulized drug mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Ddrug).
The active compound mass was calculated as the product of drug mass
and the proportion of active compound mass contained in drug mass (active
compound mass = D drug X tactivecompound).


<b>2.3 Particle size measurement (Figure 2)</b>

To determine the particle size of the aerosol drug produced by the Aeroneb
Go nebulizer, we used a device that takes measurements by means of the
laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).
5
<u>Figure 1 : Experimental set up for inhaled mass measurement</u>
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
<i>Figure 2 : Particle size measurement set-up</i>
7
<div class="FTQUOTE"><begin quote><b>3. Results</b>

{I only included the chart for Tobi here}

<b><i>3.4 Tobi® (300mg/5ml)</i></b>

Nebulizer....tobramycine inhaled mass....MMAD.....Nebulization time
()...........................mg..............................(µm)............(min)

Aeroneb Go 1a .....109................................ 3.3 ..............14
Aeroneb Go 1b..... 103 ............................... 3.8 ..............16
Aeroneb Go 2a .... 106................................ 4.2 ..............21
Aeroneb Go 2b..... 105 ................................3.7.............. 10
Aeroneb Go 3a..... 113................................ 3.8 ............. 15
Aeroneb Go 3b .....110 ................................3.2 ..............14
mean ...................108 ................................3.7 ............ 15
standard deviation ....4 ................................0.4 ................4
Table 4 : inhaled mass, nebulization time and MMAD results for Tobi®</end quote></div>
9
<b>4. Conclusion</b>
The bromide ipratropium inhaled mass of the nebulized Atrovent®
(0.5mg/2ml) with the Aeroneb Go® nebulizer was 0.17mg ± 0.02mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Atrovent® nebulized
by Aeroneb Go® was 4.4µm ± 0.1µm.
The duration to nebulize the Atrovent® with Aeroneb Go® was 4min ± 1min.
The terbutaline inhaled mass of the nebulized Bricanyl® (5mg/2ml) with the
Aeroneb Go® nebulizer was 1.7mg ± 0.3g.
The Mass Median Aerodynamic Diameter (MMAD) of the Bricanyl® nebulized
by Aeroneb Go® was 4.8µm ± 0.1µm.
The duration to nebulize the Bricanyl® with Aeroneb Go® was 4min ± 0.5min.
The salbutamol inhaled mass of the nebulized Ventoline® (5mg/2.5ml) with
the Aeroneb Go® nebulizer was 1.4mg ± 0.2mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Ventoline®
nebulized by Aeroneb Go® was 4.8µm ± 0.2µm.
The duration to nebulize the Ventoline® with Aeroneb Go® was 5min ± 1min.
<div class="FTQUOTE"><begin quote><i><u>The tobramycin inhaled mass of the nebulized Tobi® (300mg/5ml) with the
Aeroneb Go® nebulizer was 108mg ± 4mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Tobi® nebulized by
Aeroneb Go® was 3.7µm ± 0.4µm.
The duration to nebulize the Tobi® with Aeroneb Go® was 15min ± 3min.
10</u></i></end quote></div>

References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
11
Tours, 2006/09/13
Laurent Vecellio

 

[AnD]

And this one?

1
<b>EVALUATION OF THE AERONEB GO® NEBULIZER
PERFORMANCES WITH ATROVENT® (0.5mg/2ml),
BRICANYL® (5mg/2ml), VENTOLINE® (5mg/2.5ml)
AND TOBI® (300mg/5ml)
STUDY REPORT</b>

INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
September 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 t calculation ________________________________________________________________ 3
2.2.3 Active compound mass calculation ____________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Atrovent® (0.5mg/2ml) __________________________________________________ 7
3.2 Bricanyl® (5mg/2ml) ____________________________________________________ 7
3.3 Ventoline® (5mg/2.5ml) _________________________________________________ 8
3.4 Tobi® (300mg/5ml) _____________________________________________________ 8
4. Conclusion ________________________________________________________ 9
References_______________________________________________________________ 10
3
1. Study Objective
The objective of this study was to measure the inhaled mass and the particle size
of different drugs (Atrovent®, Bricanyl®, Ventoline®, Tobi®) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).
<b>2. Measurement method</b>
The experimental set up defined by EN13544-1 European standard and the
mass measurement methods defined in the article (2) were used in this
study.
<b>2.1 Tested Materials</b>
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Atrovent® 0.5mg/2ml (Boehringer Ingelheim, France) Batch 238224
- Bricanyl® 5mg/2ml (Astra Zeneca, Suède) Batch HC1518
- Ventoline® 5mg/2.5ml (GlaxoSmithKline) Batch G7278
- Tobi® 300mg/5ml (Chiron, USA)


<b>2.2 Inhaled Mass (IM)</b>

<b>2.2.1 Experimental setup </b>(Figure 1)

Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for drug collection was positioned between the nebulizer and the
piston pump (Harvard, USA). Filters were changed every 5 minutes until the end
of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.
2.2.2 t calculation
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
4
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
The relative mass of the active compound (t) (ipratropium bromide for
Atrovent®, terbutaline for Bricanyl®, salbutamol for Ventoline® and tobramycin
for Tobi®) in total solute mass (active compound + excipients=drug) collected on
the filters was measured as follows. 3 Pari filters (Pari filter, Pari, Germany) were
weighed for each drug. 0.25 mg of ipratropium bromide (1 ml of the Atrovent®
at a concentration of 0.25mg/ml) was placed with a pipette onto each of three
Pari filters. 2.5 mg of terbutaline (1 ml of the Bricanyl® at a concentration of
2.5mg/ml) was placed with a pipette onto each of three Pari filters. 2 mg of
salbutamol (1 ml of the Ventoline® at a concentration of 2 mg/ml) was placed
with a pipette onto each of three Pari filters. 60 mg of tobramycine (1 ml of the
Tobi® at a concentration of 50mg/ml) was placed with a pipette onto each of
three Pari filters. All filters were dried in the scale room during a 24-hour period.
The difference between the weight of each filter after solution pipetting and
drying and its weight before pipetting was calculated (Ddrug). The value of
tactivecompound was calculated by determining the ratio between the active
compound mass deposited on the filter and D drug.

<b>2.2.3 Active compound mass calculation</b>

The nebulized drug mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Ddrug).
The active compound mass was calculated as the product of drug mass
and the proportion of active compound mass contained in drug mass (active
compound mass = D drug X tactivecompound).


<b>2.3 Particle size measurement (Figure 2)</b>

To determine the particle size of the aerosol drug produced by the Aeroneb
Go nebulizer, we used a device that takes measurements by means of the
laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).
5
<u>Figure 1 : Experimental set up for inhaled mass measurement</u>
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
<i>Figure 2 : Particle size measurement set-up</i>
7
<div class="FTQUOTE"><begin quote><b>3. Results</b>

{I only included the chart for Tobi here}

<b><i>3.4 Tobi® (300mg/5ml)</i></b>

Nebulizer....tobramycine inhaled mass....MMAD.....Nebulization time
()...........................mg..............................(µm)............(min)

Aeroneb Go 1a .....109................................ 3.3 ..............14
Aeroneb Go 1b..... 103 ............................... 3.8 ..............16
Aeroneb Go 2a .... 106................................ 4.2 ..............21
Aeroneb Go 2b..... 105 ................................3.7.............. 10
Aeroneb Go 3a..... 113................................ 3.8 ............. 15
Aeroneb Go 3b .....110 ................................3.2 ..............14
mean ...................108 ................................3.7 ............ 15
standard deviation ....4 ................................0.4 ................4
Table 4 : inhaled mass, nebulization time and MMAD results for Tobi®</end quote>
9
<b>4. Conclusion</b>
The bromide ipratropium inhaled mass of the nebulized Atrovent®
(0.5mg/2ml) with the Aeroneb Go® nebulizer was 0.17mg ± 0.02mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Atrovent® nebulized
by Aeroneb Go® was 4.4µm ± 0.1µm.
The duration to nebulize the Atrovent® with Aeroneb Go® was 4min ± 1min.
The terbutaline inhaled mass of the nebulized Bricanyl® (5mg/2ml) with the
Aeroneb Go® nebulizer was 1.7mg ± 0.3g.
The Mass Median Aerodynamic Diameter (MMAD) of the Bricanyl® nebulized
by Aeroneb Go® was 4.8µm ± 0.1µm.
The duration to nebulize the Bricanyl® with Aeroneb Go® was 4min ± 0.5min.
The salbutamol inhaled mass of the nebulized Ventoline® (5mg/2.5ml) with
the Aeroneb Go® nebulizer was 1.4mg ± 0.2mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Ventoline®
nebulized by Aeroneb Go® was 4.8µm ± 0.2µm.
The duration to nebulize the Ventoline® with Aeroneb Go® was 5min ± 1min.
<div class="FTQUOTE"><begin quote><i><u>The tobramycin inhaled mass of the nebulized Tobi® (300mg/5ml) with the
Aeroneb Go® nebulizer was 108mg ± 4mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Tobi® nebulized by
Aeroneb Go® was 3.7µm ± 0.4µm.
The duration to nebulize the Tobi® with Aeroneb Go® was 15min ± 3min.
10</u></i></end quote>

References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
11
Tours, 2006/09/13
Laurent Vecellio

 

[AnD]

And this one?

1
<b>EVALUATION OF THE AERONEB GO® NEBULIZER
PERFORMANCES WITH ATROVENT® (0.5mg/2ml),
BRICANYL® (5mg/2ml), VENTOLINE® (5mg/2.5ml)
AND TOBI® (300mg/5ml)
STUDY REPORT</b>

INSERM U-618
Aerosol team
Faculty of Medicine
37032 Tours
France
September 2006
2
1. Study Objective ____________________________________________________ 3
2. Measurement method_______________________________________________ 3
2.1 Tested Materials _______________________________________________________ 3
2.2 Inhaled Mass (IM) ______________________________________________________ 3
2.2.1 Experimental setup (Figure 1)_________________________________________________ 3
2.2.2 t calculation ________________________________________________________________ 3
2.2.3 Active compound mass calculation ____________________________________________ 4
2.3 Particle size measurement (Figure 2) ____________________________________ 4
3. Results ____________________________________________________________ 7
3.1 Atrovent® (0.5mg/2ml) __________________________________________________ 7
3.2 Bricanyl® (5mg/2ml) ____________________________________________________ 7
3.3 Ventoline® (5mg/2.5ml) _________________________________________________ 8
3.4 Tobi® (300mg/5ml) _____________________________________________________ 8
4. Conclusion ________________________________________________________ 9
References_______________________________________________________________ 10
3
1. Study Objective
The objective of this study was to measure the inhaled mass and the particle size
of different drugs (Atrovent®, Bricanyl®, Ventoline®, Tobi®) generated by the
Aeroneb Go® nebulizer (Aerogen, USA).
<b>2. Measurement method</b>
The experimental set up defined by EN13544-1 European standard and the
mass measurement methods defined in the article (2) were used in this
study.
<b>2.1 Tested Materials</b>
-3 Aeroneb Go® nebulizers (Aerogen, Gallway, Ireland), each nebulizer was
tested 2 times (n=6)
- Atrovent® 0.5mg/2ml (Boehringer Ingelheim, France) Batch 238224
- Bricanyl® 5mg/2ml (Astra Zeneca, Suède) Batch HC1518
- Ventoline® 5mg/2.5ml (GlaxoSmithKline) Batch G7278
- Tobi® 300mg/5ml (Chiron, USA)


<b>2.2 Inhaled Mass (IM)</b>

<b>2.2.1 Experimental setup </b>(Figure 1)

Nebulizers were connected to a piston pump (Harvard, U.S.A.) set at a
frequency of 15/min, 500 ml tidal volume, and a 50/50 inspiration/expiration ratio.
A filter holder containing a non-absorbent Pari filter (Pari, Starnberg,
Germany) for drug collection was positioned between the nebulizer and the
piston pump (Harvard, USA). Filters were changed every 5 minutes until the end
of nebulization. Pari filters were weighed before aerosol collection and after
aerosol collection and filter drying. The duration of the nebulization was defined
by the time of nebulization generation until the end of aerosol generation.
2.2.2 t calculation
All measurements were performed at a hygrometry of humidity levels
ranging from 35% to 55%. The scale (Precisa 40SM-200A, Sartorius, Bradford,
U.K.) had a 0.01 mg precision. The output measurements took into account the
absolute dryness of the filters and the relative mass of the drug in the aerosol
4
collected. The drying of filters before and after aerosol collection was obtained
by keeping them during 24 hours each time in the scale room.
The relative mass of the active compound (t) (ipratropium bromide for
Atrovent®, terbutaline for Bricanyl®, salbutamol for Ventoline® and tobramycin
for Tobi®) in total solute mass (active compound + excipients=drug) collected on
the filters was measured as follows. 3 Pari filters (Pari filter, Pari, Germany) were
weighed for each drug. 0.25 mg of ipratropium bromide (1 ml of the Atrovent®
at a concentration of 0.25mg/ml) was placed with a pipette onto each of three
Pari filters. 2.5 mg of terbutaline (1 ml of the Bricanyl® at a concentration of
2.5mg/ml) was placed with a pipette onto each of three Pari filters. 2 mg of
salbutamol (1 ml of the Ventoline® at a concentration of 2 mg/ml) was placed
with a pipette onto each of three Pari filters. 60 mg of tobramycine (1 ml of the
Tobi® at a concentration of 50mg/ml) was placed with a pipette onto each of
three Pari filters. All filters were dried in the scale room during a 24-hour period.
The difference between the weight of each filter after solution pipetting and
drying and its weight before pipetting was calculated (Ddrug). The value of
tactivecompound was calculated by determining the ratio between the active
compound mass deposited on the filter and D drug.

<b>2.2.3 Active compound mass calculation</b>

The nebulized drug mass was measured under the nebulization
conditions described in the Experimental Set-up section above, by weighing
filters both before aerosol collection and after aerosol collection and filter drying
(Ddrug).
The active compound mass was calculated as the product of drug mass
and the proportion of active compound mass contained in drug mass (active
compound mass = D drug X tactivecompound).


<b>2.3 Particle size measurement (Figure 2)</b>

To determine the particle size of the aerosol drug produced by the Aeroneb
Go nebulizer, we used a device that takes measurements by means of the
laser diffraction method (Mastersizer-X).
The mouthpiece of the nebulizer was positioned at a distance of 1 cm from
the lens and 2 cm from the laser beam. The aerosol was sprayed across the
laser beam and toward a vacuum pump positioned 5 cm beyond the beam
and set at an output rate of 25 l/min.
The Mastersizer-X acquired data during all the aerosol generation. The data
inversion calculation was computed by the Mastersizer-X software for
calculate the mass median mass aerodynamic diameter (MMAD).
5
<u>Figure 1 : Experimental set up for inhaled mass measurement</u>
Respiratory pump
Compressor
Filter
Nebulizer
6
1 cm
1 cm
100 mm LENS
MOUTHPIECE
NEBULIZER
LASER
EXTRACTION
DETECTOR
5 cm
<i>Figure 2 : Particle size measurement set-up</i>
7
<div class="FTQUOTE"><begin quote><b>3. Results</b>

{I only included the chart for Tobi here}

<b><i>3.4 Tobi® (300mg/5ml)</i></b>

Nebulizer....tobramycine inhaled mass....MMAD.....Nebulization time
()...........................mg..............................(µm)............(min)

Aeroneb Go 1a .....109................................ 3.3 ..............14
Aeroneb Go 1b..... 103 ............................... 3.8 ..............16
Aeroneb Go 2a .... 106................................ 4.2 ..............21
Aeroneb Go 2b..... 105 ................................3.7.............. 10
Aeroneb Go 3a..... 113................................ 3.8 ............. 15
Aeroneb Go 3b .....110 ................................3.2 ..............14
mean ...................108 ................................3.7 ............ 15
standard deviation ....4 ................................0.4 ................4
Table 4 : inhaled mass, nebulization time and MMAD results for Tobi®</end quote>
9
<b>4. Conclusion</b>
The bromide ipratropium inhaled mass of the nebulized Atrovent®
(0.5mg/2ml) with the Aeroneb Go® nebulizer was 0.17mg ± 0.02mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Atrovent® nebulized
by Aeroneb Go® was 4.4µm ± 0.1µm.
The duration to nebulize the Atrovent® with Aeroneb Go® was 4min ± 1min.
The terbutaline inhaled mass of the nebulized Bricanyl® (5mg/2ml) with the
Aeroneb Go® nebulizer was 1.7mg ± 0.3g.
The Mass Median Aerodynamic Diameter (MMAD) of the Bricanyl® nebulized
by Aeroneb Go® was 4.8µm ± 0.1µm.
The duration to nebulize the Bricanyl® with Aeroneb Go® was 4min ± 0.5min.
The salbutamol inhaled mass of the nebulized Ventoline® (5mg/2.5ml) with
the Aeroneb Go® nebulizer was 1.4mg ± 0.2mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Ventoline®
nebulized by Aeroneb Go® was 4.8µm ± 0.2µm.
The duration to nebulize the Ventoline® with Aeroneb Go® was 5min ± 1min.
<div class="FTQUOTE"><begin quote><i><u>The tobramycin inhaled mass of the nebulized Tobi® (300mg/5ml) with the
Aeroneb Go® nebulizer was 108mg ± 4mg.
The Mass Median Aerodynamic Diameter (MMAD) of the Tobi® nebulized by
Aeroneb Go® was 3.7µm ± 0.4µm.
The duration to nebulize the Tobi® with Aeroneb Go® was 15min ± 3min.
10</u></i></end quote>

References
1. European standard EN13544-1
2. Vecellio L, Grimbert D, Bordenave J, Benoit G, Furet Y, Fauroux B,
Boissinot E, De Monte M, Lemarie E, Diot P. 2004. Residual gravimetric
method to measure nebulizer output. J Aerosol Med. 17:63-71
11
Tours, 2006/09/13
Laurent Vecellio

 

[2005CFmom]

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cardinal.com/mps/focus/respiratory/abstracts/abstracts/ab2001/A00000082.asp
">http://www.cardinal.com/mps/fo.../ab2001/A00000082.asp
</a>

I don't know if the above site will help but.....

It is a study of droplet size, respirable dose, etc... of pulmozyme using pari nebs & compressors and other approved nebs and compressors. Maybe you can compare your study results to these and see if they fall into the same parameters?

Good luck finding any answers. The Aeroneb Go looks interesting, I'll have to do some more research when I have time.

 

[2005CFmom]

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cardinal.com/mps/focus/respiratory/abstracts/abstracts/ab2001/A00000082.asp
">http://www.cardinal.com/mps/fo.../ab2001/A00000082.asp
</a>

I don't know if the above site will help but.....

It is a study of droplet size, respirable dose, etc... of pulmozyme using pari nebs & compressors and other approved nebs and compressors. Maybe you can compare your study results to these and see if they fall into the same parameters?

Good luck finding any answers. The Aeroneb Go looks interesting, I'll have to do some more research when I have time.

 

[2005CFmom]

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cardinal.com/mps/focus/respiratory/abstracts/abstracts/ab2001/A00000082.asp
">http://www.cardinal.com/mps/fo.../ab2001/A00000082.asp
</a>

I don't know if the above site will help but.....

It is a study of droplet size, respirable dose, etc... of pulmozyme using pari nebs & compressors and other approved nebs and compressors. Maybe you can compare your study results to these and see if they fall into the same parameters?

Good luck finding any answers. The Aeroneb Go looks interesting, I'll have to do some more research when I have time.

 

[2005CFmom]

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cardinal.com/mps/focus/respiratory/abstracts/abstracts/ab2001/A00000082.asp
">http://www.cardinal.com/mps/fo.../ab2001/A00000082.asp
</a>

I don't know if the above site will help but.....

It is a study of droplet size, respirable dose, etc... of pulmozyme using pari nebs & compressors and other approved nebs and compressors. Maybe you can compare your study results to these and see if they fall into the same parameters?

Good luck finding any answers. The Aeroneb Go looks interesting, I'll have to do some more research when I have time.

 

[2005CFmom]

<a target=_blank class=ftalternatingbarlinklarge href="http://www.cardinal.com/mps/focus/respiratory/abstracts/abstracts/ab2001/A00000082.asp
">http://www.cardinal.com/mps/fo.../ab2001/A00000082.asp
</a>

I don't know if the above site will help but.....

It is a study of droplet size, respirable dose, etc... of pulmozyme using pari nebs & compressors and other approved nebs and compressors. Maybe you can compare your study results to these and see if they fall into the same parameters?

Good luck finding any answers. The Aeroneb Go looks interesting, I'll have to do some more research when I have time.

 

[AnD]

Thanks so much! That's a great link <img src="i/expressions/face-icon-small-smile.gif" border="0"> !

The only drawback with it so far is that if you exhale into it, it blows alot of the med out the vents, but since I have a habit of exhaling my Pulmozyme through my nose anyways (I figure that every little bit helps, lol) that might be okay for me- we'll see! Oh, the company that make the Aeroneb Go is where I got the articles, in an email, so that's why I posted the whole thing- I don't know how to make a link out of an Adobe file in an email <img src="i/expressions/face-icon-small-blush.gif" border="0"> .

 

[AnD]

Thanks so much! That's a great link <img src="i/expressions/face-icon-small-smile.gif" border="0"> !

The only drawback with it so far is that if you exhale into it, it blows alot of the med out the vents, but since I have a habit of exhaling my Pulmozyme through my nose anyways (I figure that every little bit helps, lol) that might be okay for me- we'll see! Oh, the company that make the Aeroneb Go is where I got the articles, in an email, so that's why I posted the whole thing- I don't know how to make a link out of an Adobe file in an email <img src="i/expressions/face-icon-small-blush.gif" border="0"> .

 

[AnD]

Thanks so much! That's a great link <img src="i/expressions/face-icon-small-smile.gif" border="0"> !

The only drawback with it so far is that if you exhale into it, it blows alot of the med out the vents, but since I have a habit of exhaling my Pulmozyme through my nose anyways (I figure that every little bit helps, lol) that might be okay for me- we'll see! Oh, the company that make the Aeroneb Go is where I got the articles, in an email, so that's why I posted the whole thing- I don't know how to make a link out of an Adobe file in an email <img src="i/expressions/face-icon-small-blush.gif" border="0"> .

 

[AnD]

Thanks so much! That's a great link <img src="i/expressions/face-icon-small-smile.gif" border="0"> !

The only drawback with it so far is that if you exhale into it, it blows alot of the med out the vents, but since I have a habit of exhaling my Pulmozyme through my nose anyways (I figure that every little bit helps, lol) that might be okay for me- we'll see! Oh, the company that make the Aeroneb Go is where I got the articles, in an email, so that's why I posted the whole thing- I don't know how to make a link out of an Adobe file in an email <img src="i/expressions/face-icon-small-blush.gif" border="0"> .

 

[AnD]

Thanks so much! That's a great link <img src="i/expressions/face-icon-small-smile.gif" border="0"> !

The only drawback with it so far is that if you exhale into it, it blows alot of the med out the vents, but since I have a habit of exhaling my Pulmozyme through my nose anyways (I figure that every little bit helps, lol) that might be okay for me- we'll see! Oh, the company that make the Aeroneb Go is where I got the articles, in an email, so that's why I posted the whole thing- I don't know how to make a link out of an Adobe file in an email <img src="i/expressions/face-icon-small-blush.gif" border="0"> .