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. Author manuscript; available in PMC: 2017 Feb 10.
Published in final edited form as: J Control Release. 2015 Nov 6;223:64–74. doi: 10.1016/j.jconrel.2015.11.006

Table 4. Results of USP rabbit pyrogen test on adjuvant loaded unmodified, phospholipid-PEG and Pluronic modified liposomes.

Formulation Assay outcome NPa or Pb (Individual temperature change values for three rabbits) Fold improvement over aqueous CRX-601c
Dose of 250 ng/kg Dose of 500 ng/kg
CRX-601/Unmodified liposome NP (0.0 °C, 0.0 °C, 0.0 °C) NP (0.0 °C, 0.3 °C, 0.0 °C) 500

Phospholipid-PEG modified liposomes

CRX-601/5 mol% PE-PEG2K liposome NP (0.0 °C, 0.1 °C, 0.0 °C) NP (0.0 °C, 0.0 °C, 0.2 °C) 500
CRX-601/25 mol% PE-PEG2K liposome NP (0.1 °C, 0.0 °C, 0.0 °C) NP (0.1 °C, 0.3 °C, 0.0 °C) 500
CRX-601/5 mol% PE-PEG5K liposome NP (0.3 °C, 0.2 °C, 0.0 °C) NP (0.0 °C, 0.0 °C, 0.4 °C) 500
CRX-601/25 mol% PE-PEG5K liposome NP (0.3 °C, 0.0 °C, 0.3 °C) NP (0.3 °C, 0.0 °C, 0.0 °C) 500

Pluronic modified liposomes

CRX-601 /15 mol% L64 liposomes P (0.3 °C, 0.6 °C, 0.7 °C) P (0.8 °C, 0.8 °C, 0.4 °C) 125d
CRX-601 /25 mol% L64 liposomes P (0.9 °C, 0.5 °C, 0.9 °C) P (0.5 °C, 0.6 °C, 0.9 °C) 125d
CRX-601/ 15 mol% F68 liposomes NP (0.0 °C, 0.0 °C, 0.4 °C) P (0.5 °C, 0.4 °C, 0.8 °C) 250
CRX-601 /25 mol% F68 liposomes NP (0.0 °C, 0.1 °C, 0.0 °C) P (0.3 °C, 0.7 °C, 0.4 °C) 250
CRX-601/15 mol% F127 liposome NP (0.2 °C, 0.0 °C, 0.1 °C) NP (0.0 °C, 0.3 °C, 0.0 °C) 500
CRX-601/25 mol% F127 liposomes NP (0.4 °C, 0.2 °C, 0.4 °C) P (0.3 °C, 0.3 °C, 0.5 °C) 250
a

NP: Non-pyrogenic response

b

P: Pyrogenic response. The test is considered NP if none of the rabbits shows an individual temperature rise of 0.5 °C or more above its respective control temperature at any point.

c

Maximum non-pyrogenic dose of aqueous CRX-601 is 1 ng/kg.

d

The formulations were non-pyrogenic at 125 ng/Kg (individual temperature changes not shown).

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