Table 3.
Experimental design matrix of the critical process parameters and the related critical quality attributes.
| Run |
Critical process parameters (CPPs) |
Critical quality attributes (CQAs) |
||||
|---|---|---|---|---|---|---|
| A PLGA (mg) |
B Drug (mg) |
C Stirring speed (rpm) |
Y1Particle sizea,c (nm) |
Y2 EE b,c (%) |
Y3 Zeta potential a,c (mV) |
|
| 1 | 10 | 15 | 750 | 215.2±2.4 | 53.1±3.5 | 9.3±1.1 |
| 2 | 10 | 10 | 1000 | 164.8±2.2 | 47.2±3.7 | 15.3±1.4 |
| 3 | 15 | 20 | 750 | 221.4±3.5 | 72.7±4.1 | 7.2±1.2 |
| 4 | 10 | 15 | 750 | 215.2±3.7 | 55.2±4.2 | 9.3±1.6 |
| 5 | 5 | 15 | 1000 | 145.6±1.8 | 60.5±3.5 | 11.8±1.4 |
| 6 | 15 | 15 | 1000 | 240.5±2.2 | 73.1±2.8 | 10.2±1.1 |
| 7 | 10 | 15 | 750 | 213.2±3.1 | 55.7±3.7 | 9.4±1.4 |
| 8 | 10 | 15 | 750 | 213.5±3.4 | 53.1±4.5 | 9.4±1.6 |
| 9 | 10 | 15 | 750 | 215.2±2.6 | 55.6±3.4 | 9.3±1.2 |
| 10 | 10 | 20 | 1000 | 179.8±1.7 | 65.1±3.6 | 10.5±1.4 |
| 11 | 5 | 15 | 500 | 172.5±2.4 | 50.7±3.3 | 8.2±1.7 |
| 12 | 5 | 20 | 750 | 110.8±1.8 | 52.5±4.2 | 10.4±1.2 |
| 13 | 10 | 10 | 500 | 175.4±3.3 | 46.3±4.4 | 8.5±1.1 |
| 14 | 15 | 15 | 500 | 235.8±3.7 | 62.4±3.4 | 5.5±1.5 |
| 15 | 5 | 10 | 750 | 130.4±2.8 | 50.5±4.6 | 11.3±1.4 |
| 16 | 15 | 10 | 750 | 169.5±2.2 | 62.9±4.1 | 10.4±1.8 |
| 17 | 10 | 20 | 500 | 189.1±3.4 | 41.5±3.8 | 10.6±1.5 |
a
Measured by DLS.
b
Calculated as a percentage of initial drug added, determined indirectly by HPLC.
c
Expressed as mean ± SD (n = 3).