Table 6 Control strategies for the niosomal formulation

Drug to span 60

Ratio

1:4—1:8 (molar ratio)

1:4–1:8 (molar ratio)

To ensure higher % drug entrapment efficiency

PBS 7.4

Volume

10–100 ml

25–75 ml

To obtain a vesicle size < 200 nm and higher % drug entrapment efficiency

Stirrer

Stirring speed

1000–2500 rpm

1750–2500 rpm

To ensure vesicle size < 200 nm

Amount of charge inducer (DCP)

Zeta potential

8 mg, 16 mg, 24 mg

8–16 mg

To maintain the zeta potential below − 30 mV so as to prevent aggregation

Heating

Temperature

50 °C–70 °C

62 °C ± 3 °C

To prevent lump formation and also avoid degradation of drug

Needle

Size

18, 22, 24 gauge

24 gauge

To get optimum vesicle size

Flow rate

Flow

0.5, 1.0,1.5, 2.0 mL/min

2 mL/min

As flow rate was not impacting the product performance, higher rate was selected to reduce manufacturing time

Sonication

Time

5 min, 15 min

5 min

To prevent lipid degradation due to heat generation