26
Particle Specifications
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a
sampling flow rate of 15 l/min equipped with a USP <601> induction port throat. Aerosol was
sampled directly from the outlet. Three (3) device samples were tested with 3 runs each, for a total
of 9 sample points per each drug.
The specifications are listed below with intervals given for a 95% confidence level.
Mean / Std. Dev
Pulmicort
®
(250µg/mL)
Intal
®
(10mg/mL)
Salbutamol
®
(5mg/mL)
Total Delivered Dose (μg) 391.11 ± 16.51 12368.89 ± 269.61 7883.33 ± 116.96
Total Delivered Dose Fraction (%)
78.2% ± 3.3% 61.8% ± 3.1% 77.0% ± 2.5%
Particle size (MMAD) μm
3.88 ± 0.28 2.91 ± 0.14 2.54 ± 0.28
Geometric Standard Deviation
1.93 ± 0.20 2.27 ± 0.02 2.62 ± 0.03
Respirable Fraction (0.5-5μm) 61.9% ± 4.0% 70.5% ± 1.3% 66.4% ± 1.6%
Total Respirable Dose
(μg between 0.5-5μm)
242.17 ± 18.90 8729.49 ± 497.57 5235.02 ± 233.61
Medication Captured on USP Throat
13.34 ± 3.40 253.66 ± 27.42 144.94 ± 16.32
Medication Captured on USP
Throat Fraction (%)
3.4% ± 0.4% 2.0% ± 0.1% 1.8% ± 0.1%
Medication Retained in Device 96.11
±
9.61 8000.00
±
438.21 2072.22
±
257.90
Medication Retained in Device
Fraction (%)
19.2% ± 1.9% 40% ± 2.2% 41.4% ± 5.2%
Coarse Particle Fraction (%) (>4.7μm) 37.1% ± 2.9% 27.7% ± 1.5% 26.6% ± 2.3%
Fine Particle Fraction (%) (<4.7μm) 59.6% ± 3.5% 70.2% ± 1.5%
71.6% ± 2.3%
Ultra-Fine Particle Fraction (%)
(<1.0μm)
3.5% ± 1.7% 8.9% ± 2.1%
16.9% ± 5.3%
NOTE: Course particles (oro-pharyngeal deposition) and ultra-fine particles (exhaled) are not likely
to deposit in the patient’s airway and thus provide limited clinical benefit.
Technical DaTa
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