TABLE 3.

List of candidate formulations for sIPV lyophilization and percent recovery of D-antigen following lyophilization^a

Formulation code	Bulking agent/stabilizer	Buffer	Sugar	pH	Surfactant	SE HPLC recovery (%)	ELISA recovery (%)
F1	2.5% glycine	10 mM Tris-HCl	1% sucrose	8	0.1% pluronic F68	89	85
F2	5% mannitol	10 mM histidine	1% sorbitol	7	None	18	19
F3	5% mannitol	10 mM histidine	1% sorbitol	7	0.1% pluronic F68	74	78
F4	5% mannitol	10 mM histidine	1% sorbitol	7	0.5% pluronic F68	91	95
F5	5% mannitol	10 mM histidine	1% sorbitol	7	1.0% pluronic F68	92	91
F6	5% mannitol	10 mM histidine	1% sucrose	7	0.1% pluronic F68	65	88
F7r	5% mannitol	10 mM histidine	1% sucrose	7	0.5% pluronic F68	72	73
F8	5% mannitol	10 mM histidine	1% sorbitol	7	0.01% polysorbate 20	91	90
F9	5% mannitol	10 mM histidine	1% sucrose	7	0.01% polysorbate 20	90	91
F10	5% mannitol	10 mM histidine	1% sorbitol	7	0.1% polysorbate 20	76	81
F11	5% mannitol	10 mM histidine	1% sorbitol	7	0.5% polysorbate 20	77	78
F12	5% mannitol	10 mM histidine	1% sorbitol	7	0.05% polysorbate 20	75	82
F13	5% mannitol	10 mM histidine	1% sucrose	7	0.1% polysorbate 20	80	74
F14	2.5% glycine	10 mM histidine	1% sucrose	7	0.1% pluronic F68	42	76
F15	2.5% glycine	10 mM histidine	1% sorbitol	6	0.1% pluronic F68	59	N.T.
F16	2.5% glycine	10 mM histidine	1% sucrose	6	0.1% pluronic F68	58	N.T.
F17	5% mannitol	10 mM histidine	1% sorbitol	6	0.1% pluronic F68	61	N.T.
F18	2.5% glycine	10 mM histidine	1% sorbitol	6	0.1% pluronic F68	65	N.T.

^aMgSO₄ (1 mM) was used as a stabilizer for all formulations. N.T., not tested.