Table 2.
Quality by Design (QbD)—Niosome Batch Experimental Design Table.
| Batch ID # | Critical Material Attributes | Critical Processing Parameters | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug (mg) | Organic Phase Composition | Span 60 (mg) | Cholesterol (mg) | Stearic Acid (mg) | External Phase Temperature (°C) | External Phase Volume (mL) | Internal Phase Volume (mL) | Mixing Speed (RPM) | Mixing Time (Minutes) | Add. Rate (mL/Min) | |
| DND-1 | 20 | diethyl ether | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-2 | 20 | diethyl ether : ethanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-3 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-4 | 20 | ethanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-5 | 20 | acetone | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-6 | 30 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-7 | 40 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-8 | 20 | diethyl ether : methanol | 20 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-9 | 20 | diethyl ether : methanol | 30 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-10 | 20 | diethyl ether : methanol | 50 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-11 | 20 | diethyl ether : methanol | 60 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-12 | 20 | diethyl ether : methanol | 70 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-13 | 20 | diethyl ether : methanol | 40 | 30 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-14 | 20 | diethyl ether : methanol | 40 | 40 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-15 | 20 | diethyl ether : methanol | 40 | 50 | 5 | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-16 | 20 | diethyl ether : methanol | 40 | 20 | 5 (SA) | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-17 | 20 | diethyl ether : methanol | 40 | 20 | N/A | 65 | 20 | 10 | 650 | 60 | 1.00 |
| DND-18 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 55 | 20 | 10 | 650 | 60 | 1.00 |
| DND-19 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 75 | 20 | 10 | 650 | 60 | 1.00 |
| DND-20 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 10 | 10 | 650 | 60 | 1.00 |
| DND-21 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 30 | 10 | 650 | 60 | 1.00 |
| DND-22 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 15 | 650 | 60 | 1.00 |
| DND-23 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 20 | 650 | 60 | 1.00 |
| DND-24 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 450 | 60 | 1.00 |
| DND-25 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 550 | 60 | 1.00 |
| DND-26 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 30 | 1.00 |
| DND-27 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 45 | 1.00 |
| DND-28 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 0.25 |
| DND-29 | 20 | diethyl ether : methanol | 40 | 20 | 5 | 65 | 20 | 10 | 650 | 60 | 0.50 |