Table 7
Examples of formulation of cytokine product [10]
Trade name
Formulation
Betaferon/Betaseron/Extavia f Lyophilized powder:
IFN-β-1b (300 μg)
Human albumin (15 mg)
Mannitol (15 mg)
Solvent (1.2 mL): water for injections
Sodium chloride (5.4 mg/mL)
Avonex
Lyophilized powder:
IFN-β-1a (33 μg)
HSA (16.5 mg)
Sodium phosphate dibasic (6.3 mg)
Sodium phosphate monobasic (1.3 mg)
Sodium chloride (6.4 mg)
Solvent (1.0 mL): water for injections, pH 7.3 (after reconstitution)
Proleukin
Lyophilized powder:
Aldesleukin (rhIL-2) (1.3 mg)
Mannitol (60 mg)
SDS (0.22 mg)
Sodium phosphate monobasic (0.20 mg)
Sodium phosphate dibasic (1.1 mg)
Solvent (1.2 mL): water for injections, pH 7.5 Æ 0.3 (after
reconstitution)
Neumega
Lyophilized powder:
Oprelvekin (rhIL-11) (5.0 mg)
Glycine (23 mg)
Dibasic sodium phosphate heptahydrate (1.6 mg)
Monobasic sodium phosphate monohydrate (0.55 mg)
Solvent (1.0 mL): water for injections, pH 7.0
Granocyte
Lyophilized powder:
Lenograstim (rhG-CSF) (105 or 263 μg)
Arginine (10 mg)
Phenylalanine (10 mg)
Methionine (1.0 mg)
Mannitol (25 mg)
Polysorbate 20 (0.1 mg)
Hydrochloric acid
Solvent (1.0 mL): water for injections, pH 6.5 after reconstitution
Leukine
Lyophilized powder:
Sargramostim (rhGM-CSF) (250 μg)
Mannitol (40 mg)
Sucrose (10 mg)
Tromethamine (1.2 mg)
Solvent (1.0 mL): water or 0.9% benzyl alcohol pH 7.1–7.7
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Baolin Liu and Xinli Zhou