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. 2014 Apr 2;103(6):1701–1710. doi: 10.1002/jps.23964

Table 1.

 Summary of the Formulation Conditions

Base Buffera pHb Excipientc Storage Conditions Methods
Initial Screening of pH and Additives
Na-citrate 3.0 100 mM NaCl, 0.25 M sucrose, 0.01% Tween 80 Initial/no storage; 40°C, 4 days; 2 mg/mLd DLS, DSF
Glycine 3.5
Na-acetate 4.0
Na-acetate 4.5
Na-acetate 5.0
Succinate 5.5
Histidine 6.0
Histidine 6.5
Imidazole 7.0
Glycyl–glycine 8.0
Glycine 9.0
Glycine 10.0
Stability Studies Under Accelerated Storage Conditions
Na-citrate 3.3 100 mM NaCl, 0.25 M sucrose, 0.05% Tween 80 Initial/no storage; 40°C, 8 weeks; 12 mg/mLd SAXSe, UV280 nm, SE-HPLC, LabChip
Na-acetate 5.0
Histidine 6.5
Na-phosphate 7.4
Tris–HCl 8.5
Stability Studies Under Normal Storage Conditions
Histidinef 6.5 0.25 M sucrose Initial/no storage; 5°C, 8 weeks; 25°C, 8 weeks; 2 mg/mLd SE-HPLC, iCE
Na-phosphateg 7.4 100 mM NaCl
a

Final concentration of the base buffers was 50 mM.

b

Measured at room temperature.

c

Excipients were included respectively to each of the base buffers.

d

Antibody concentration during storage.

e

Only the samples at initial time point were measured by SAXS.

f

Formulation A.

g

Formulation B.