US2021070850A1PendingUtilityA1

Pharmaceutical formulations for adalimumab

47
Assignee: ALVOTECH HFPriority: Sep 20, 2017Filed: Sep 14, 2018Published: Mar 11, 2021
Est. expirySep 20, 2037(~11.2 yrs left)· nominal 20-yr term from priority
Inventors:Gudrun BachmannElin Edwald
A61K 47/02A61K 47/26A61K 9/0019C07K 2317/94A61K 39/39591C07K 16/241C07K 2317/76C07K 2317/21A61K 47/10A61K 39/3955
47
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Claims

Abstract

A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.

Claims

exact text as granted — not AI-modified
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.

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