Table 1: Next Generation Impactor Salmeterol Deposition by Flow Rate and Duration of Inhalation.
SalmeterolFlow Rate (l/min) / 30 / 60 / 90
Duration (s) / 2 / 4 / 6 / 2 / 4 / 6 / 2 / 4 / 6
Throat (µg) / 6.66 / 5.37 / 5.81 / 5.96 / 6.43 / 4.99 / 5.36 / 5.40 / 4.51
PSa (µg) / 24.60 / 24.05 / 24.73 / 27.81 / 27.05 / 28.57 / 27.36 / 27.36 / 29.53
S1 (µg) / 1.03 / 1.10 / 1.03 / 2.01 / 2.03 / 2.40 / 3.87 / 4.25 / 4.20
S2 (µg) / 1.72 / 2.42 / 2.28 / 3.37 / 3.35 / 3.82 / 3.85 / 4.07 / 4.55
S3 (µg) / 2.50 / 3.15 / 2.88 / 3.30 / 3.42 / 3.75 / 3.36 / 3.61 / 3.50
S4 (µg) / 2.05 / 2.76 / 2.69 / 2.32 / 2.68 / 2.50 / 2.37 / 2.48 / 2.47
S5 (µg) / BLOQ / 0.74 / 0.65 / BLOQ / 0.87 / BLOQ / BLOQ / BLOQ / BLOQ
S6 (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
S7 (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
MOCb (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
TEDc (µg) / 39.07 / 39.60 / 40.23 / 45.21 / 45.82 / 46.60 / 46.62 / 47.65 / 49.32
FPDd (µg) / 5.39 / 7.13 / 6.63 / 9.26 / 10.15 / 10.48 / 11.86 / 12.67 / 13.00
MMADe (µm) / 5.18 / 5.08 / 4.95 / 4.26 / 4.03 / 4.32 / 3.83 / 3.86 / 3.91
GSDf / 1.77 / 1.80 / 1.88 / 1.81 / 1.89 / 1.87 / 2.23 / 2.26 / 2.12
a PS – Pre-separator
b MOC – Micro-orifice Collector
c TED – Total Emitted Dose
d FPD – Fine Particle Dose
e MMAD – Mass Median Aerodynamic Diameter
f GSD – Geometric Standard Deviation
BLOQ – Below Limit of Quantification (0.63 micrograms)
Table 2: Next Generation Impactor Fluticasone Deposition by Flow Rate and Duration of Inhalation.
FluticasoneFlow Rate (L/min) / 30 / 60 / 90
Duration (s) / 2 / 4 / 6 / 2 / 4 / 6 / 2 / 4 / 6
Throat (µg) / 32.72 / 25.17 / 28.54 / 29.77 / 32.11 / 23.98 / 26.64 / 27.92 / 23.29
PSa (µg) / 119.13 / 116.82 / 118.02 / 130.41 / 123.50 / 131.70 / 128.31 / 128.04 / 137.15
S1 (µg) / 5.13 / 5.29 / 5.04 / 9.74 / 9.45 / 11.10 / 18.12 / 19.50 / 19.65
S2 (µg) / 8.58 / 12.05 / 11.58 / 16.69 / 13.42 / 19.45 / 20.25 / 20.65 / 24.74
S3 (µg) / 13.05 / 16.73 / 15.23 / 17.92 / 17.97 / 21.16 / 19.60 / 18.66 / 20.88
S4 (µg) / 11.22 / 14.00 / 15.26 / 13.77 / 13.08 / 13.86 / 13.91 / 13.58 / 14.94
S5 (µg) / 3.38 / 4.52 / 3.66 / 2.98 / 8.35 / 3.82 / 2.84 / 2.84 / 2.96
S6 (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
S7 (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
MOCb (µg) / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ / BLOQ
TEDc (µg) / 193.22 / 194.59 / 197.54 / 221.28 / 217.87 / 225.07 / 229.68 / 231.19 / 243.62
FPDd (µg) / 28.83 / 36.82 / 35.48 / 50.35 / 52.53 / 56.93 / 65.42 / 65.11 / 72.64
MMADe (µm) / 4.98 / 4.98 / 4.84 / 4.03 / 3.63 / 4.10 / 3.47 / 3.65 / 3.63
GSDf / 1.79 / 1.78 / 1.87 / 1.82 / 1.86 / 1.77 / 2.22 / 2.23 / 2.08
a PS – Pre-separator
b MOC – Micro-orifice Collector
c TED – Total Emitted Dose
d FPD – Fine Particle Dose
e MMAD – Mass Median Aerodynamic Diameter
f GSD – Geometric Standard Deviation
BLOQ – Below Limit of Quantification (1.50 micrograms)
Table 3: Next Generation Impactor Salbutamol Deposition by Flow Rate and Duration of Inhalation.
SalbutamolFlow Rate (L/min) / 30 / 60 / 90
Duration (s) / 2 / 4 / 6 / 2 / 4 / 6 / 2 / 4 / 6
Throat (µg) / 14.31 / 14.77 / 15.38 / 15.13 / 15.18 / 23.15 / 19.52 / 21.88 / 18.61
PSa (µg) / 60.89 / 62.56 / 67.96 / 77.88 / 79.28 / 67.38 / 87.57 / 73.21 / 90.58
S1 (µg) / 15.00 / 15.29 / 17.45 / 15.32 / 15.45 / 18.97 / 17.56 / 17.21 / 16.40
S2 (µg) / 13.42 / 15.26 / 14.29 / 11.27 / 11.93 / 17.26 / 13.38 / 13.73 / 13.05
S3 (µg) / 19.48 / 20.14 / 22.03 / 19.12 / 16.95 / 21.78 / 14.98 / 16.09 / 16.33
S4 (µg) / 21.90 / 24.67 / 23.16 / 25.90 / 24.94 / 29.68 / 18.77 / 22.58 / 21.30
S5 (µg) / 10.42 / 11.49 / 11.68 / 14.14 / 12.43 / 13.74 / 15.27 / 18.46 / 16.13
S6 (µg) / 4.12 / 3.64 / 3.87 / 5.59 / 3.78 / 2.45 / 6.77 / 6.68 / 6.90
S7 (µg) / BLOQ / 3.66 / 3.76 / 3.59 / 3.81 / 2.14 / 6.85 / 6.30 / 6.60
MOCb (µg) / BLOQ / 5.20 / 3.69 / 4.62 / 4.74 / 2.04 / 7.72 / 6.75 / 7.47
TEDc (µg) / 160.64 / 176.68 / 183.26 / 192.57 / 188.49 / 198.59 / 208.39 / 202.90 / 213.37
FPDd (µg) / 60.52 / 72.90 / 72.08 / 83.29 / 77.49 / 85.87 / 87.66 / 94.55 / 91.41
MMADe (µm) / 4.51 / 4.08 / 4.32 / 2.60 / 2.67 / 3.06 / 1.92 / 1.87 / 1.88
GSDf / 2.24 / 2.44 / 2.29 / 2.17 / 2.12 / 2.42 / 2.94 / 2.59 / 2.66
a PS – Pre-separator
b MOC – Micro-orifice Collector
c TED – Total Emitted Dose
d FPD – Fine Particle Dose
e MMAD – Mass Median Aerodynamic Diameter
f GSD – Geometric Standard Deviation
BLOQ – Below Limit of Quantification (2.00 micrograms)
Table 4: Demographics of ten healthy volunteers recruited for pharmacokinetic study.
Demographics / All subjectsAge (years), mean (SD) / 31.1 (9.6)
Sex, M:F (%) / 70:30
Body mass index (kg/m2), mean (SD) / 23.1 (2.7)
Height (cm), mean (SD) / 173.7 (10.0)
Weight (kg), mean (SD) / 69.5 (9.8)
Race, n (%)
White – White/ Caucasian/ European / 8 (80)
Asian – Central/ South Asian / 2 (20)
S1
Salmeterol TED (%) = 0.2743252 *IFRc (l/min) + 72.45552
Adjusted R2 = 0.8578
IFRc (p = 0.000, η 2= 0.87560023), Duration (p = 0.139 : excluded) Equation 7
Fluticasone TED (%) = 0.2613995 *IFRc (l/min) + 68.58059
Adjusted R2 = 0.8905
IFRc (p = 0.000, η 2= 0.90420469), Duration (p = 0.151 : excluded) Equation 8
Salbutamol TED (%) = 0.2766179 *IFRc (l/min) + 79.52355
Adjusted R2 = 0.7254
IFRc (p = 0.002, η 2= 0.75976047), Duration (p = 0.124 : excluded ) Equation 9
S2
Salmeterol UAD (%) = 0.1044824 *IFRc (l/min) + 64.04375
Adjusted R2 = 0.7428
IFRc (p = 0.003, η 2= 0.7749831), Duration (p = 0.486 : excluded) Equation 10
Fluticasone UAD (%) = 0.0460495 *IFRc (l/min) + 63.44969
Adjusted R2 = 0.3945
IFRc (p = 0.041, η 2= 0.47021845), Duration (p = 0.915 : excluded) Equation 11
Salbutamol UAD (%) = 0.0969904 *IFRc (l/min) + 49.78972
Adjusted R2 = 0.4452
IFRc (p = 0.031, η 2= 0.51457348), Duration (p = 0.253 : excluded) Equation 12