US 12,383,622 B2
Pre-mixed, ready-to-use pharmaceutical compositions
Michelle Renee Duncan, Glenview, IL (US); Supriya Gupta, Waverly, IA (US); David Hartley Haas, Fremont, CA (US); Norma V. Nenonene, Skokie, IL (US); and Camellia Zamiri, Fremont, CA (US)
Assigned to CHIESI USA, INC., Cary, NC (US)
Filed by CHIESI USA, INC., Cary, NC (US)
Filed on Dec. 9, 2022, as Appl. No. 18/078,333.
Application 12/407,557 is a division of application No. 11/788,076, filed on Apr. 18, 2007, granted, now 7,612,102, issued on Nov. 3, 2009.
Application 18/078,333 is a continuation of application No. 16/938,198, filed on Jul. 24, 2020, granted, now 11,547,758.
Application 16/938,198 is a continuation of application No. 16/010,898, filed on Jun. 18, 2018, granted, now 10,758,616.
Application 16/010,898 is a continuation of application No. 15/159,495, filed on May 19, 2016, abandoned.
Application 15/159,495 is a continuation of application No. 12/977,965, filed on Dec. 23, 2010, granted, now 9,370,586, issued on Jun. 21, 2016.
Application 12/977,965 is a continuation of application No. 12/645,169, filed on Dec. 22, 2009, granted, now 9,364,564, issued on Jun. 14, 2016.
Application 12/645,169 is a continuation of application No. 12/407,557, filed on Mar. 19, 2009, granted, now 7,659,291, issued on Feb. 9, 2010.
Claims priority of provisional application 60/793,074, filed on Apr. 18, 2006.
Prior Publication US 2023/0165962 A1, Jun. 1, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 31/4422 (2006.01); A61K 31/455 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/26 (2006.01); A61K 47/40 (2006.01); A61K 47/69 (2017.01); B82Y 5/00 (2011.01); C08B 37/16 (2006.01); C08L 5/16 (2006.01)
CPC A61K 47/02 (2013.01) [A61K 9/0019 (2013.01); A61K 31/4422 (2013.01); A61K 31/455 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/40 (2013.01); A61K 47/6951 (2017.08); B82Y 5/00 (2013.01); C08B 37/0015 (2013.01); C08L 5/16 (2013.01)] 12 Claims
 
1. A method for making a pharmaceutical composition for intravenous administration comprising
preparing a pre-mixed aqueous solution with a pH from about 3.6 to about 4.4 comprising:
from about 0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt thereof; and
a tonicity agent;
and filling a pharmaceutically acceptable container with the aqueous solution such that the aqueous solution is in contact with non-polar polymers; the aqueous solution when stored in the container for at least three months at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%.