US2018028657A1PendingUtilityA1

Stable Aqueous Formulations of Adalimumab

73
Assignee: COHERUS BIOSCIENCES INCPriority: Sep 7, 2012Filed: Oct 11, 2017Published: Feb 1, 2018
Est. expirySep 7, 2032(~6.1 yrs left)· nominal 20-yr term from priority
Inventors:Mark ManningRobert W. Payne
A61P 9/00A61P 9/04A61P 9/10A61P 35/00A61P 29/00A61P 31/04A61P 11/06A61P 25/00A61P 19/02A61P 1/04A61K 47/20A61K 9/0019A61K 47/12C07K 2317/24C07K 2317/94A61K 47/10A61K 47/26A61K 47/18A61K 39/39533A61K 47/24A61K 47/14A61K 39/39591A61K 47/22A61K 2039/545A61K 2039/505A61K 47/02C07K 16/241A61K 47/183A61K 2039/542C07K 2317/21A61K 9/08A61K 39/3955
73
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Claims

Abstract

The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A stable aqueous pharmaceutical composition comprising:
 i) adalimumab;   ii) a buffer;   iii) trehalose; and   iv) a surfactant;   
       wherein the formulation has a pH of about 5 to about 6 and is free of citrate buffer and phosphate buffer. 
     
     
         2 . The composition of  claim 1 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 
     
     
         3 . The composition of  claim 1 , wherein the buffer comprises acetate. 
     
     
         4 . The composition of  claim 1 , wherein the surfactant comprises polysorbate 80. 
     
     
         5 . The composition of  claim 4 , wherein the buffer comprises acetate. 
     
     
         6 . The composition of  claim 5 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 
     
     
         7 . The composition of  claim 1 , wherein the composition is free of sodium chloride. 
     
     
         8 . The composition of  claim 7 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 
     
     
         9 . The composition of  claim 7 , wherein the buffer comprises acetate. 
     
     
         10 . The composition of  claim 7 , wherein the surfactant comprises polysorbate 80. 
     
     
         11 . The composition of  claim 10 , wherein the buffer comprises acetate. 
     
     
         12 . The composition of  claim 11 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

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