US 12,102,594 B2
Infusion bag of Midazolam for intravenous use
Samarth Kumar, Baroda (IN); Maheshkumar Parasmal Soni, Baroda (IN); Nishit Patel, Baroda (IN); Prashant Kane, Baroda (IN); and Subhas Balaram Bhowmick, Baroda (IN)
Assigned to Sun Pharmaceutical Industries Limited, Mumbai (IN)
Filed by Sun Pharmaceutical Industries Limited, Maharashtra (IN)
Filed on Jan. 3, 2022, as Appl. No. 17/646,861.
Application 17/646,861 is a continuation of application No. 16/865,841, filed on May 4, 2020, granted, now 11,246,801.
Application 16/865,841 is a continuation of application No. 16/796,292, filed on Feb. 20, 2020, granted, now 11,273,100.
Claims priority of application No. 201921006935 (IN), filed on Feb. 22, 2019.
Prior Publication US 2022/0233403 A1, Jul. 28, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61J 1/14 (2023.01); A61J 1/10 (2006.01); A61K 31/55 (2006.01); A61K 47/02 (2006.01)
CPC A61J 1/1468 (2015.05) [A61J 1/10 (2013.01); A61J 1/1475 (2013.01); A61K 31/55 (2013.01); A61K 47/02 (2013.01)] 19 Claims
 
1. A ready-to-use pre-filled syringe comprising a stable, aqueous solution of midazolam, wherein the solution comprises:
a. 0.1 mg/ml to 2.0 mg/ml of midazolam or a base equivalent concentration of a pharmaceutically salt thereof;
b. a tonicity adjusting agent;
c. a pH adjusting agent; and
d. water for injection,
wherein the syringe was subjected to terminal sterilization by autoclaving, and the solution has a pH of 3.0 to 4.5.