Facial and ocular deposition of nebulized budesonide: effects of face mask design.
BACKGROUND
In vivo case reports and in vitro studies have indicated that aerosol therapy using face masks can result in drug deposition on the face and in the eyes, and that face mask design may affect drug delivery.


OBJECTIVE
To test different mask/nebulizer combinations for budesonide, a nebulized steroid used to treat pediatric patients with asthma.


METHODS
Using high-performance liquid chromatography, drug delivery (inhaled mass), facial, and ocular deposition of budesonide aerosols were studied in vitro using a ventilated face facsimile (tidal volume, 50 mL; rate, 25 breaths/min, duty cycle 0.4), a tight-fitting test mask, a standard commercial mask, and a prototype mask designed to optimize delivery by reducing particle inertia. Nebulizer insertion into the mask (front loaded vs bottom loaded) was also tested. Particle size was measured by cascade impaction. Pari LC Plus (PARI Respiratory Equipment; Midlothian, VA) and MistyNeb (Allegiance; McGaw Park, IL) nebulizers were tested.


RESULTS
Inhaled mass for tight-fitting and prototype masks was similar (13.2 +/- 1.85% vs 14.4 +/- 0.67% [percentage of nebulizer charge], p = 0.58) and significantly greater than for the commercial mask (3.03 +/- 0.26%, p = 0.005). Mask insertion of nebulizer was a key factor (inhaled mass: front loaded vs bottom loaded, 8.23 +/- 0.18% vs 3.03 +/- 0.26%; p = 0.005). Ocular deposition varied by an order of magnitude and was a strong function of mask design (4.77 +/- 0.24% vs 0.35 +/- 0.05%, p = 0.002, tight fitting vs prototype). Particle sizes (7.3 to 9 microm) were larger than previously reported for budesonide.


CONCLUSIONS
For pediatric breathing patterns, mask design is a key factor defining budesonide delivery to the lungs, face, and eyes. Front-loaded nebulizer mask combinations are more efficient than bottom-loaded systems.
Harris
Keith W
KW
Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, State University of New York, Stony Brook, NY 11794-8172, USA.
Smaldone
Gerald C
GC
D000336:Aerosols; D019819:Budesonide / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D004867:Equipment Design; D005123:Eye; D005145:Face; D005938:Glucocorticoids / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008397:Masks; D009330:Nebulizers and Vaporizers; D014018:Tissue Distribution
D000336:Aerosols; D005938:Glucocorticoids; D019819:Budesonide