Table 4: Physico-chemical properties of the cSLN S1A and S2A produced in different operative conditions. The specific variable(s) which characterize each batch [volume of the aqueous phase (10 or 50 ml); glass or plastic tube; S25N-10G or S25N-8G probe accessory] are evidenced in bold under the column ‘Conditions’.

Batch Conditions Z-ave (nm) PDI ZP (mV) Yield % Drug content (µg/ml)
S1A 10 ml
glass
S25N-10G
233.9 + 2.33 0.224 + 0.030 +47.4 + 2.17 66.76 245 + 32
S1A 50 ml
glass
S25N-10G
253.8 + 2.46 0.206 + 0.044 +48.8 + 2.00 70.80 570 + 32
S1A 10 ml
glass
S25N-8G
194.6 + 0.21 0.148 + 0.020 +44.3 + 1.00 100.00 429 + 22
S2A 10 ml
glass
S25N-10G
245.0 + 2.11 0.270 + 0.010 +53.0 + 3.20 31.90 278 + 15
S2A 10 ml
plastic
S25N-10G
207.3 + 4.56 0.188 + 0.013 +57.0 + 1.04 67.30 108 + 23
S2A 50 ml
glass
S25N-10G
273.4 + 6.16 0.342 + 0.018 +29.4 + 0.64 35.30 234 + 31
S2A 10 ml
plastic
S25N-8G
182.3 + 7.01 0.191 + 0.009 +49.6 + 0.34 89.88 244 + 22