Theoretical Basis for the EDA Concept - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 158

Table 7.1 Regression analysis and goodness-of-it statistics for LPM/SPM ratio versus MMAD

Optimum
boundary b (μm)

Average
MMAD (μm)

Coeficient of
determination, R 2 (%)

RMSE / b
(μm) OIP ilecode a Product type CI runs ( n ) Slope ( b ) RMSE c

w9k201 HFA suspension MDI 80 4.7 3.91 0.4071 0.0162 96.4 0.040

w9j901 HFA suspension MDI 39 3.3 2.57 0.4959 0.0350 93.4 0.071

w9j801 HFA solution MDI 201 2.1 1.50 0.7155 0.0421 96.2 0.059

w9jk01 Dry powder inhaler 279 3.3 2.66 0.4319 0.0201 83.0 0.047

w9k901 Dry powder inhaler d 279 2.0 2.59 2.3831 0.1278 84.3 0.054

w9j601 CFC suspension MDI 43 2.1 2.54 2.4548 0.0872 95.5 0.036

w9k001 CFC suspension MDI 272 3.3 3.54 1.6127 0.0330 97.3 0.020

w9kw01 CFC suspension MDI 272 3.3 2.86 0.7046 0.0198 95.8 0.028

a The ilecodes are unique, randomly-generated alpha-numerical labels assigned to speciic products in the IPAC-RS database
b Here, optimum boundary is based on results from the eight-stage Andersen Impactor
c RMSE —root-mean-square error
d Modiied Andersen nonviable CI used for this product