In vitro performance characteristics of valved holding chamber and spacer devices with a fluticasone metered-dose inhaler.
OBJECTIVE
To compare the in vitro aerosol deposition characteristics of several commercially available valved holding chamber (VHC) and spacer devices used with a fluticasone metered-dose inhaler (MDI).


METHODS
In vitro aerosol deposition study


METHODS
University-affiliated research center.


METHODS
Seven VHC devices: BreatheRite, E-Z Spacer, EasiVent, AeroChamber, InspirEase, OptiChamber, and Space Chamber. Six spacer devices: OptiHaler, Aerosol Cloud Enhancer (ACE), Gentle-Haler, MediSpacer, Ellipse, and a 6-inch tube (1-inch inside diameter).


METHODS
The respirable dose (aerosol particles 1-5 microm) of fluticasone was determined by sampling 10 220-microg actuations from five runs with each spacer or VHC plus MDI combination, by using a well-established in vitro cascade impactor method.


RESULTS
Fluticasone aerosol was washed from the impactor with methanol and quantified by means of high-performance liquid chromatography. Differences among outcomes were determined with analysis-of-variance testing. Among spacers, Ellipse had the highest respirable dose (104 microg, p < 0.01). Respirable doses for the 6-inch tube (74.3 microg), Gentle-Haler (81.7 microg), and MediSpacer (82.6 microg) were no different from that of the MDI (p > 0.05), whereas respirable doses of OptiHaler (44.6 microg) and ACE (47.2 microg) were less than those of all other spacers (p < 0.001). Among VHC devices, respirable doses from EasiVent (35.6 microg), AeroChamber (47.0 microg), InspirEase (52.7 microg), OptiChamber (53.1 microg), and Space Chamber (58.3 microg) were not different (p > 0.05), whereas BreatheRite (13.1 microg) and E-Z Spacer (27.3 microg) respirable doses were less than those of the other VHC devices (p < 0.05).


CONCLUSIONS
Spacers and VHC devices available in the United States do not demonstrate equivalent in vitro performance with the fluticasone MDI. The difference between highest and lowest respirable doses in each device category would likely lead to clinically relevant differences in the quantity of fluticasone delivered to a patient.
Asmus
Michael J
MJ
Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville 32610-0486, USA. asmus@cop.ufl.edu
Liang
Judy
J
Coowanitwong
Intira
I
Hochhaus
Gunther
G
D000336:Aerosols / Q000032:analysis / Q000737:chemistry; D000730:Androstadienes / Q000008:administration & dosage*; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design / Q000295:instrumentation / Q000379:methods; D000068298:Fluticasone; D005544:Forecasting; D001239:Inhalation / Q000187:drug effects / Q000502:physiology; D036503:Inhalation Spacers; D010316:Particle Size; D010366:Peak Expiratory Flow Rate / Q000187:drug effects / Q000502:physiology
D000336:Aerosols; D000730:Androstadienes; D000068298:Fluticasone