Table 2 Model summary statistics of drug release, T90, aspect ratio and eR of ER coated pellets of Meclizine HCl.

From: QbD based Eudragit coated Meclizine HCl immediate and extended release multiparticulates: formulation, characterization and pharmacokinetic evaluation using HPLC-Fluorescence detection method

Models

Eudragit RL100®

Eudragit RS100®

Mean squares

F value

p value

prob > F

SD

Adj. R-Sq

Pred. R-Sq

Press

Pred. Model

Mean Square

F value

p value

prob > F

SD

Adj. R-Sq

Pred. R-Sq

Press

Pred. model

Drug release (DR)

Linear

1.55

386.31

˂ 0.0001

1.030

0.984

0.975

30.950

Linear

< 0.0001

Sig

7.46

72.73

˂ 0.0001

2.260

0.9189

0.886

136.160

Linear

< 0.0001

Sig

2FI

1.97

0.35

0.7866

1.100

0.982

0.941

73.370

10.21

0.017

0.9968

2.510

0.9005

0.683

380.220

Quadratic

2.43

0.99

0.4381

1.100

0.981

0.927

91.980

8.16

3.34

0.0640

2.020

0.9355

0.743

308.490

Cubic

10.92

0.17

0.9452

1.350

0.972

− 0.921

2,406.86

27.33

0.74

0.5985

2.130

0.9279

− 4.017

6,023.49

Time for 90% drug release (T90)

Linear

1.69

1.49

0.2559

1.080

0.071

− 0.415

33.610

Quadratic

0.2438

Not Sig

0.00

N/A

2FI

2.32

0.00

1.0000

1.200

− 0.143

− 1.314

54.970

0.00

Quadratic

1.96

2.97

0.0834

0.990

0.214

− 2.135

74.460

0.00

Cubic

2.50

4.40

0.0531

0.640

0.667

− 22.158

550.01

0.00

Aspect ratio (AR)

Linear

6.685E − 004

5.46

0.0089

0.021

0.413

0.193

0.012

Linear

0.0065

Sig

1.239E − 004

0.54

0.6590

9.231E − 003

− 0.077

− 0.514

2.274E − 003

Quadratic

0.0121

Not Sig

2FI

9.191E − 004

0.000

1.0000

0.024

0.278

− 1.134

0.032

1.704E − 004

0.00

1.0000

0.010

− 0.326

− 1.787

4.188E − 003

Quadratic

4.955E − 004

6.56

0.0100

0.016

0.684

− 0.257

0.019

5.760E − 005

12.45

0.0010

5.367E − 003

0.636

− 0.453

2.184E − 003

Cubic

2.355E − 003

0.078

0.9863

0.020

0.499

− 33.883

0.520

7.664E − 005

4.14

0.0603

3.574E − 003

0.838

− 10.243

0.017

Two dimensional shape factor (eR)

Linear

6.833E − 004

56.69

˂0.0001

0.022

0.898

0.844

0.014

Quadratic

< 0.0001

Sig

2.581E − 004

22.63

˂0.0001

0.013

0.773

0.710

4.309E − 003

Quadratic

< 0.0001

Sig

2FI

8.858E − 004

0.26

0.8509

0.023

0.881

0.837

0.014

3.036E − 004

0.73

0.5515

0.014

0.761

0.433

8.434E − 003

Quadratic

8.890E − 005

49.81

˂ 0.0001

6.667E − 003

0.990

0.959

3.501E − 003

9.224E − 005

14.22

0.0006

6.791E − 003

0.941

0.758

3.596E − 003

Cubic

2.867E − 004

0.83

0.5539

6.912E − 003

0.989

0.277

0.063

6.860E − 005

8.58

0.0117

3.381E − 003

0.985

− 0.016

0.015