Table 3.
Formulation factors and parameter variations for process scale up
| PLGA (mg) | PVA %(w/v) | Ethyl acetate (ml) | Aqueous phase (ml) | Excess Water (ml) | Sonication Tip* | Sonication Time (s) | Stirrer Speed (rpm) | Stirrer Time (h) | |
|---|---|---|---|---|---|---|---|---|---|
|
Primary optimized conditions |
85 |
1 |
4.25 |
15 |
40 |
S2 |
60 |
2000 |
4 |
|
First stage – 500 mg |
500 |
1 |
5 |
20 |
50 |
S2 |
120 |
2000 |
4 |
|
Second stage – 1 g |
1000 |
1 |
10 |
40 |
60 |
S14 |
120 |
3000 |
6 |
|
Third stage- 2 g |
2000 |
1 |
20 |
60 |
80 |
S14 |
180 |
6000 |
6 |
| Fourth stage – 5 g | 5000 | 1 | 50 | 150 | 200 | S14 | 300 | 8000 | 6 |
*S2 – soncation tip dia – 2 mm, S14 – sonication tip dia – 14 mm.