US 10,376,588 B2
Etanercept formulations stabilized with combinations of sugars and polyols
Mark Manning, Johnstown, CO (US); and Brian Murphy, Fort Collins, CO (US)
Assigned to Coherus Biosciences, Inc., Redwood City, CA (US)
Filed by Coherus Biosciences, Inc., Redwood City, CA (US)
Filed on Mar. 9, 2018, as Appl. No. 15/917,333.
Application 15/917,333 is a continuation of application No. 15/078,755, filed on Mar. 23, 2016, granted, now 9,943,601.
Application 15/078,755 is a continuation of application No. 13/654,950, filed on Oct. 18, 2012, granted, now 9,302,002, issued on Apr. 5, 2016.
Claims priority of provisional application 61/669,480, filed on Jul. 9, 2012.
Claims priority of provisional application 61/548,518, filed on Oct. 18, 2011.
Prior Publication US 2018/0193463 A1, Jul. 12, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/26 (2006.01); A61K 39/395 (2006.01); C07K 14/715 (2006.01); C07K 14/705 (2006.01); A61K 47/18 (2017.01); A61K 47/10 (2017.01); A61K 9/00 (2006.01); A61K 38/17 (2006.01); A61K 9/16 (2006.01); A61K 9/14 (2006.01); A61K 9/08 (2006.01); A61K 38/19 (2006.01); A61P 29/00 (2006.01); A61P 19/02 (2006.01); A61P 17/06 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 9/14 (2013.01); A61K 9/16 (2013.01); A61K 38/17 (2013.01); A61K 38/1793 (2013.01); A61K 38/191 (2013.01); A61K 39/39591 (2013.01); A61K 47/10 (2013.01); A61K 47/18 (2013.01); C07K 14/705 (2013.01); C07K 14/7151 (2013.01); A61P 17/06 (2018.01); A61P 19/02 (2018.01); A61P 29/00 (2018.01); C07K 2319/30 (2013.01)] 13 Claims
 
1. A stable aqueous pharmaceutical composition comprising
(a) about 50 mg/mL etanercept,
(b) about 1 to about 10 wt. % sugar,
(c) up to about 10 wt. % polyol, and
(d) an aqueous carrier,
wherein said composition
(i) is free or essentially free of arginine,
(ii) has a pH of about 6.0 to about 6.6, and
(iii) has at M3 or T2 or T4 no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 μm, and
wherein said sugar and said polyol are different from each other and the combination of said sugar and said polyol stabilizes said etanercept in said stable aqueous pharmaceutical composition.