PHARMACEUTICAL FORMULATIONS FOR ADALIMUMAB
A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.
1 . A pharmaceutical composition, comprising:
pharmaceutical-grade water having dissolved and/or suspended therein (a) 90-110 mg/ml of adalimumab; (b) 5 mM to 25 mM of a salt; (c) 180 mM to 300 mM of a polyol; and (d) 0.1% (w/v) of a polysorbate;
wherein said composition is buffer-less.
2 . The pharmaceutical composition according to claim 1 , wherein said salt is a chloride salt.
3 . The pharmaceutical composition according to claim 2 , wherein said salt is NaCl.
4 . The pharmaceutical composition according to claim 1 , wherein said polyol is selected from mannitol, sucrose, and combinations thereof.
5 . The pharmaceutical composition according to claim 4 , wherein said polyol is mannitol and said polyol concentration is between 220 mM and 240 mM.
6 . The pharmaceutical composition according to claim 4 , wherein said polyol is sucrose and said polyol concentration is between 240 mM and 270 mM.
7 . The pharmaceutical composition according to claim 1 , wherein said polysorbate is polysorbate 80 or polysorbate 20.
8 . The pharmaceutical composition according to claim 1 , wherein said salt concentration is from 10 mM to 20 mM.
9 . The pharmaceutical composition according to claim 7 , wherein said salt is NaCl, said salt concentration is 10 mM, said polyol is mannitol, and said polyol concentration is 230 mM.
10 . The pharmaceutical composition according to claim 7 , wherein said salt is NaCl, said salt concentration is 10 mM, said polyol is sucrose, and said polyol concentration is 255 mM.
11 . The pharmaceutical composition according to claim 1 , wherein said composition has an osmolality within the range of 300 to 400 mOsm/kg.
12 . The pharmaceutical composition according to claim 1 , wherein said composition has a pH between 4.9 and 5.5.
13 . The pharmaceutical composition according to claim 2 , wherein said salt is selected from MgCl 2 , KCl, NaCl, CaCl 2 , or combinations thereof.
14 . The pharmaceutical composition according to claim 13 , wherein said salt concentration is from 10 mM to 20 mM.
15 . The pharmaceutical composition according to claim 14 , wherein said salt is NaCl.
16 . The pharmaceutical composition according to claim 11 , wherein said composition has an osmolality within the range of 330 to 380 mOsm/kg.
17 . The pharmaceutical composition according to claim 12 , wherein said composition has a pH of 5.2±0.2.
18 . The pharmaceutical composition according to claim 9 , wherein said polysorbate is polysorbate 80.
19 . The pharmaceutical composition according to claim 18 , wherein said composition has a pH of 5.2±0.2.
20 . The pharmaceutical composition according to claim 10 , wherein said polysorbate is polysorbate 80.