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 265

Table 9.4 Calculated group deposition ( μ g), LPM/SPM ratio, and MMAD ( From [ 11 ] —used with permission )

(a) Study 1
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)

1.22 1.25 0.84 1.11 0.64 0.71 0.69 0.72 0.73 0.67 0.78 0.75 0.67 0.75 0.79 0.76

Group 3
(S4-S6)

3.02 3.15 3.02 3.33 3.36 3.32 3.69 3.34 3.36 3.15 3.72 3.87 2.91 3.42 3.34 3.62

Group 4 (S7-F) 3.17 3.17 3.56 3.41 4.51 4.67 5.02 4.50 4.77 5.12 4.76 5.39 3.36 3.87 3.70 3.76

MMAD ( μ m) 1.03 1.04 0.88 1.00 0.78 0.76 0.77 0.78 0.77 0.70 0.81 0.76 0.86 0.87 0.88 0.90

LPM / SPM at
0.83

1.13 1.17 0.97 1.13 0.78 0.75 0.77 0.78 0.73 0.64 0.82 0.76 0.91 0.93 0.95 1.01

μ m

LPM / SPM at
1.36

0.53 0.53 0.42 0.51 0.26 0.24 0.24 0.25 0.24 0.22 0.26 0.23 0.30 0.31 0.31 0.32

μ m

LPM / SPM at
2.30

0.24 0.24 0.18 0.22 0.05 0.05 0.04 0.05 0.04 0.04 0.05 0.05 0.06 0.06 0.06 0.06

μ m

LPM / SPM at
3.99

0.09 0.09 0.06 0.08 0.02 0.02 0.02 0.02 0.02 0.01 0.02 0.02 0.02 0.03 0.03 0.03

μ m

(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

Group 2
(S1-S3)

1.25 1.37 1.26 1.14 0.74 0.94 0.74 0.74 0.85 0.89 0.90 0.89 0.82 0.81 0.93 0.82

Group 3
(S4-S6)

3.74 3.41 3.43 3.86 3.40 3.51 3.39 3.21 3.27 3.56 3.88 3.64 3.19 3.20 3.81 4.07

Group 4 (S7-F) 3.51 3.06 3.10 3.63 4.05 3.67 3.96 3.83 4.29 4.28 4.12 3.79 3.84 3.90 4.13 4.20

MMAD ( μ m) 1.11 1.20 1.16 1.06 0.85 0.95 0.86 0.85 0.81 0.85 0.92 0.94 0.86 0.85 0.90 0.90

(continued)