Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 266

Table 9.4 (continued)

(b) Study 2
MDI Variant 1 Variant 2 Variant 3 Variant 4 Variant 5 Variant 6 Variant 7 Variant 8

Can 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2

LPM / SPM at
0.83

1.28 1.37 1.33 1.24 0.92 1.07 0.94 0.92 0.84 0.91 1.03 1.06 0.90 0.88 0.98 1.02

μ m

LPM / SPM at
1.36

0.68 0.73 0.69 0.62 0.41 0.48 0.43 0.42 0.31 0.35 0.45 0.48 0.33 0.32 0.30 0.31

μ m

LPM / SPM at
2.30

0.29 0.33 0.29 0.26 0.14 0.17 0.15 0.14 0.11 0.12 0.15 0.17 0.10 0.09 0.06 0.06

μ m

LPM / SPM at
3.99

0.10 0.12 0.10 0.09 0.05 0.05 0.05 0.04 0.04 0.04 0.05 0.05 0.03 0.03 0.03 0.03

μ m

(c) Study 3
MDI

Variant 1 Variant 2 Variant 3 Variant 4 Variant 5 Variant 6 Variant 7 Variant 8

Can 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2

Group 2
(S1-S3)

1.63 1.41 1.20 1.36 1.07 1.05 1.01 1.25 0.70 0.86 0.99 1.07 0.84 0.84 0.60 0.60

Group 3
(S4-S6)

3.80 3.29 3.50 3.71 3.53 3.59 3.40 3.24 3.00 3.37 4.64 3.55 3.36 3.13 3.52 3.21

Group 4 (S7-F) * 2.94 2.56 3.09 2.90 3.53 3.44 3.29 3.18 4.41 3.80 4.48 3.60 3.78 3.63 3.43 3.10

MMAD ( μ m) 1.36 1.37 1.15 1.26 1.01 1.03 1.03 1.09 0.75 0.89 0.97 1.00 0.91 0.88 0.91 0.92

LPM / SPM at
0.83

1.60 1.59 1.36 1.56 1.17 1.22 1.19 1.18 0.76 1.00 1.17 1.14 0.97 0.94 1.07 1.08

μ m

LPM / SPM at
1.36

0.83 0.83 0.69 0.78 0.57 0.59 0.58 0.58 0.30 0.39 0.53 0.56 0.38 0.37 0.33 0.34

μ m

LPM / SPM at
2.30

0.37 0.37 0.28 0.33 0.24 0.24 0.23 0.24 0.13 0.16 0.22 0.24 0.13 0.13 0.06 0.07

μ m

LPM / SPM at
3.99

0.14 0.13 0.10 0.12 0.09 0.08 0.08 0.08 0.05 0.06 0.06 0.08 0.04 0.04 0.02 0.02

μ m