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Particle Specifications
A series of aerosol performance tests were performed using an 8-stage cascade impactor at sampling
flow rates of 13 l/min and 30 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 99 % confidence level.
The upper value is based on the sampling flow rate of 13 l/min, and the lower value (in parentheses) is
based on the sampling flow rate of 30 l/min.
Mean / Std. Dev
Total Delivered Dose (μg)
Total Delivered Dose Fraction
(%)
Particle size (MMAD) (μm)
Geometric Standard Deviation
Respirable Fraction
(0.5-5 μm) (%)
Total Respirable Dose between
0.5-5 μm (μg)
Medication Captured on USP
Throat (μg)
Medication Captured on USP
Throat Fraction (%)
Medication Retained in Device
(μg)
Medication Retained in Device
Fraction (%)
Coarse Particle Fraction (%)
(>4.7 μm)
Fine Particle Fraction (%)
(<4.7 μm)
Ultra-Fine Particle Fraction (%)
(<1.0 μm)
Note
Coarse 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.
Pulmicort®
(250 μg/mL)
(10 mg/mL)
321
(350)
66
(70)
5.56
(4.99)
2.2
(2.2)
45
(49)
1.5
(1.7)
11.5
(12.3)
4
(4)
165
(150)
34
(30)
55
(51)
44
(49)
1
(2)
Intal®
Salbutamol®
(5 mg/mL)
13392
6684
(12873)
(6795)
66
(64)
(68)
3.22
2.93
(2.55)
(2.05)
2.8
(2.5)
(3.6)
61
(67)
81.6
37.5
(86.0)
(41.3)
318.0
160.1
(252.1)
(141.7)
2
(2)
6777
3135
(7127)
(3135)
34
(36)
37
(29)
(28)
63
(69)
(73)
11
(16)
7. Specifications
68
3.2
56
(61)
2
(2)
32
(32)
36
63
20
(32)
22
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