US 12,343,427 B1
Stable intravenous diltiazem hydrochloride formulation and use thereof
Niravbhai Jayantibhai Patel, Sacramento, CA (US); Robert Miller, Sacramento, CA (US); Maheshkumar Kalubhai Bhalaria, Sacramento, CA (US); Mahesh Sadashiv Khade, Sacramento, CA (US); Rucha Abhijit Kelekar, Sacramento, CA (US); Dasaradhi Lakkaraju, Sacramento, CA (US); and Jay Shukla, Sacramento, CA (US)
Assigned to Nivagen Pharmaceuticals, Inc., Sacramento, CA (US)
Filed by Nivagen Pharmaceuticals, Inc., Sacramento, CA (US)
Filed on Apr. 23, 2024, as Appl. No. 18/643,088.
Int. Cl. A61K 9/08 (2006.01); A61J 1/10 (2006.01); A61K 9/00 (2006.01); A61K 31/554 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01)
CPC A61K 9/08 (2013.01) [A61J 1/10 (2013.01); A61K 9/0019 (2013.01); A61K 31/554 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01)] 12 Claims
 
1. A stable, isotonic injectable diltiazem composition, said composition consisting of:
about 0.5-1.5 mg/mL diltiazem HCL as an active pharmaceutical ingredient; and
about 0.4 mg/mL or less of a buffer for maintenance of pH, said buffer selected from the group consisting of: (a) about 0.15 mg/mL citric acid monohydrate and about 0.12 mg/mL tri-sodium citrate dihydrate, and (b) about 0.01 to 0.02 mg/mL sodium acetate trihydrate and acetic acid; and
a pharmaceutically acceptable salt as a tonicity agent; and
water for injection;
wherein the composition has a pH of about 2.5 to about 5.0.