US 12,186,362 B2
Vasopressin formulations for use in treatment of hypotension
Matthew Kenney, New Haven, MI (US); Vinayagam Kannan, Rochester, MI (US); Sunil Vandse, Basking Ridge, NJ (US); and Suketu Sanghvi, Kendall Park, NJ (US)
Assigned to Par Pharmaceutical, Inc., Chestnut Ridge Road, NY (US)
Filed by Par Pharmaceutical, Inc., Chestnut Ridge, NY (US)
Filed on Sep. 10, 2021, as Appl. No. 17/472,393.
Application 17/472,393 is a continuation of application No. 16/291,915, filed on Mar. 4, 2019, granted, now 11,135,265.
Application 16/291,915 is a continuation of application No. 15/864,597, filed on Jan. 8, 2018, abandoned.
Application 15/864,597 is a continuation of application No. 15/688,341, filed on Aug. 28, 2017, abandoned.
Application 15/688,341 is a continuation of application No. 15/612,649, filed on Jun. 2, 2017, granted, now 9,925,233, issued on Mar. 27, 2018.
Prior Publication US 2022/0133838 A1, May 5, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/095 (2019.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 31/045 (2006.01); A61K 45/06 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01); G01N 30/74 (2006.01); G01N 30/02 (2006.01)
CPC A61K 38/095 (2019.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 31/045 (2013.01); A61K 45/06 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01); G01N 30/74 (2013.01); G01N 2030/027 (2013.01)] 18 Claims
 
1. A pharmaceutical formulation, comprising:
a) about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
b) an acetate buffer;
c) dextrose or sodium chloride or combinations thereof; and
d) water;
wherein the formulation has a pH of about 3.5 to about 4;
wherein the formulation is stable at a room temperature of between about 20° ° C. to about 25° C. for up to about 8 months; and
wherein the formulation comprises no more than about 17% total impurities.