Are there differences in throat deposition using variable valved holding chambers? L. Bakuridze1, S. Neckermann2, V. Andrieu1, J.C. Dubus3 1Laboratoire de Pharmacie Galénique, Faculté de Pharmacie, 27 bd J. Moulin 13385 Marseille cedex 5 France; 2PARI GmbH, 82319 Starnberg, Germany Service de médecine infantile, CHU Timone-Enfants, 13385 Marseille Cedex 5, France contact: [email protected] Introduction
Valved holding chambers (VHC) assist patients in their “hand-
Uniformity of Dose Delivery Throat deposition
breathing coordination” by providing a reservoir. Moreover, due to
The uniformity of dose delivery was characterized by a dose unit
As shown in Fig. 2, all tested VHCs reduce oropharyngeal deposition of
the retention of large aerosol particles, VHCs can effectively reduce
sampling apparatus according to Ph. Eur. based on 10 puffs Flutide®
fluticasone compared with the MDI alone (78 µg). Among the non-
throat deposition and therefore topical side effects of steroids.
HFA MDI and fired from 3 canisters, each.
electrostatic VHCs, throat deposition for VORTEX® was significantly
Non-electrostatic-VHCs additionally feature beneficial effects, e.g.:
It could be shown that the delivery of the three tested MDIs varies
more than 4-fold lower in comparison to Nebuchamber® (2.1 vs. 8.7°µg)
only in a range of +/- 6 µg from the mean value (Data not shown).
and more than 2-fold in comparison to AC Max® (2.1 vs. 4.4°µg). This
an increase in delivery of small particles by reducing undesired
effect may be due to the cyclone-twist principle of the VORTEX® which
drug loss to the inner surface of the chamber
Mass Median Aerodynamic Diameter (MMAD)
may help in the retention of large aerosolized drug particles.
an improved dose consistency even with variations in delay
The MMAD of the aerosol emitted from the fluticasone-MDI alone and
The very efficient reduction in throat deposition by the Babyhaler® (0.22
from the VHCs (except Babyhaler®) is in a range of about 3 µm. The
µg) is associated with a more than 3-fold reduction in FPD (13°µg; see
In addition the metal non-electrostatic VORTEX® (PARI) with its
remarkably lower MMAD obtained from the Babyhaler® is probably
figure 1) leading to a possibly suboptimal therapeutic dose.
inspiratory cyclone twist principle could improve the aerosol deli-
attributed to its large volume (350°ml) leading to an increased
very for patients by improving the clearance of the chamber.
adhesion of drug particles to the inner surface of the tube.
Aim of the study MDI alone Nebuchamber® VORTEX® AC Plus® Babyhaler® MMAD 3.15 ± 0.46 2.99 ± 0.17 3.03 ± 0.17 3.12 ± 0.18 3.06 ± 0.26 2.43 ± 0.45
Most studies about VHCs primarily focus on determining the Fine
Particle Dose (FPD) of a specific MDI and VHC combination and
disregard measurement of the throat deposition.
Table 2: MMAD of the MDI alone and in association with the five VHCs
Therefore the aim of our study was to examine both the FPD and
dose [µg] dose [µg]
the throat deposition for non-electrostatic VHCs in comparison to
Fine Particle Dose (FPD)
Fig. 1 shows the FPDs (particles < 4.7°µm) for the five VHCs and the
Materials and Methods
MDI alone. It can be seen that the group of the three non-electrostatic
VHCs deliver similar FPD, ranging from 48°µg (VORTEX®) up to
5 puffs of a HFA-fluticasone MDI (Flutide® 125 µg, GSK) were
54°µg (Nebuchamber®) without significant differences within this
fired at 1 minute interval via a distinct VHC into an Anderson 8-
stage impactor in accordance with European Pharmacopoeia
The two electrostatic VHCs, AC Plus® (34°µg) and especially Baby-
(Ph. Eur.) at 28.3°l/min (28.2 ± 2.1°C and 53.3 ± 7% relative
haler® (13 µg), show a significant loss in FPD. This means that on
humidity). The USP induction port (throat) and each stage of the
average the group of non-electrostatic VHCs delivers 46% and 161%
Figure°2: Throat deposition of the MDI alone (A) and with five VHCs (B)
impactor were eluted and an aliquot was assayed by HPLC and
higher FPD in comparison to AC Plus® and Babyhaler®, respectively. Conclusion
Tests were carried out 3 times with 3 VHCs each
Statistical analysis was done by ANOVA and t-test (p < 0.05)
Although the Babyhaler® reduces throat deposition, it can be assumed
Name / Manufacturer Volume / Material
that the very low FPD bears a potential risk of under dosing
electrostatic AeroChamber® Plus (AC Plus)
The high throat deposition of the Nebuchamber® negates a primary
Figure°1: The group
advantage of VHC use: reduction of oropharyngeal deposition and
dose [µg] AeroChamber® Max (AC Max) of non-electrostatic VHCs deliver signi- ficantly the highest
Since VORTEX® is very effective in reducing throat deposition
Babyhaler® / GSK FPD in comparison
combined with a high FPD of fluticasone, VORTEX® may improve
Nebuchamber® / AstraZeneca to AC Plus and the Fine particle Babyhaler®(particles VORTEX® < 4.7 µm) Table 1: Main characteristics of the five VHCs used in this study
European Respiratory Society Annual Congress 2006, September 2-6, Munich, Germany
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Are there differences in throat deposition using variable valved holding chambers?