Table 5
Examples of formulation for freeze-drying of proteins [5, 8]
Name
Formulation
Protective
efficacy
Experimental conditions
Catalase
(ox liver)
8.4 μg/mL catalase, 10 mM phosphate
buffer (pH 7.0) + 1 M
glycerol + 0.5 mM sodium dodecyl
sulfate
Activity
retention:
80%
95%
90%
Freezing between À15 and
À70
C
for 10 min
Elastase
20 mg/mL elastase, 10 mM sodium
acetate buffer solution (pH 5.0) + 10%
(w/v) sucrose + 10% (w/v) dextran 40
Activity
retention:
33%
86%
82%
Storage at temperature of
40
C and relative
humidity of 79% for
2 weeks
β-Galactosidase 20 μg/mL β-galactosidase, 200 mM
phosphate buffer (pH 7.4), 100 mM
inositol + 400 mM inositol + 400 mM
inositol, 1 mg/mL dextran + 400 mM
Inositol, 1 mg/mL CMC-Na
Activity
retention:
47%
90%
100%
100%
Freeze-drying
Recombinant
factor XIII
(rFXIII)
2 mg/mL recombinant factor XIII,
0.1 mM EDTA, 10 mM Tris buffer
(pH 8) + 100 mM mannitol + 1%
(w/v) PEG + 3.5% (w/v)
dextran + 100 mM
trehalose + 100 mM sucrose + 0.002%
(w/v) Tween 20
Activity
retention:
82%
90%
115%
109%
117%
111%
106%
Freeze-drying
H
+ -ATPase
1 mg/mL
1 H
+ -ATPase, 1 mM EDTATris buffer (pH 7.0) + 20 mg
trehalose/1 mg protein + 20 mg
maltose/1 mg protein + 20 mg
sucrose/1 mg protein + 20 mg
glucose/1 mg protein + 20 mg
galactose/1 mg protein
Activity
retention:
4%
100%
91%
84%
72%
37%
Freeze-drying
rhIL-1ra
10 mg/mL rhIL-1ra, 2% aminoacetic
acid, 10 mM sodium citrate
(pH 6.5) + 1% sucrose (w/v) + 1%
maltose (w/v) + 1% sorbitol
(w/v) + 1% trehalose (w/v)
Degeneration:
1.8%/week
0.15%/week
6.4%/week
2.3%/week
0.43%/week
Storage at temperature of
50
C
IL-2
0.8 mg/mL freeze-dried IL-2, MES
buffer (pH 7) + 0.5% sucrose
(w/v) + 5% mannitol (w/v)
Activity
retention:
47%
86%
28%
Storage at temperature of
45
C for 4 weeks
(continued)
690
Baolin Liu and Xinli Zhou