US 12,285,420 B2
Stable nimodipine parenteral formulation
S. George Kottayil, West Windsor, NJ (US); Amresh Kumar, Plainsboro, NJ (US); Prasanna Sunthankar, West Windsor, NJ (US); Vimal Kavuru, Holmdel, NJ (US); and Kamalkishore Pati, Old Bridge, NJ (US)
Assigned to ACASTI PHARMA U.S., INC., Wilmington, DE (US)
Filed by ACASTI PHARMA U.S., INC., Wilmington, DE (US)
Filed on Jun. 28, 2024, as Appl. No. 18/758,839.
Application 18/758,839 is a continuation of application No. 17/523,334, filed on Nov. 10, 2021, granted, now 12,059,415.
Application 17/523,334 is a continuation of application No. 16/281,676, filed on Feb. 21, 2019, abandoned.
Claims priority of provisional application 62/633,863, filed on Feb. 22, 2018.
Prior Publication US 2024/0350473 A1, Oct. 24, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 31/451 (2006.01); A61K 47/10 (2017.01); A61K 47/26 (2006.01); A61P 9/04 (2006.01); A61P 9/06 (2006.01); A61P 9/10 (2006.01); A61P 9/12 (2006.01); A61P 9/14 (2006.01)
CPC A61K 31/451 (2013.01) [A61K 9/0019 (2013.01); A61K 47/10 (2013.01); A61K 47/26 (2013.01); A61P 9/04 (2018.01); A61P 9/06 (2018.01); A61P 9/10 (2018.01); A61P 9/12 (2018.01); A61P 9/14 (2018.01)] 11 Claims
 
1. A method of treatment, comprising administering a therapeutically effective dose of a nimodipine concentrate formulation to a human patient suffering from a condition selected from the group consisting of aneurysms, subarachnoid hemorrhage, vasospastic angina, Prinzmetal angina, stable angina, acute myocardial infarction, myocardial arrest, arrhythmia, systemic hypertension, pulmonary hypertension, congestive heart failure, coronary artery surgery and hypertrophic cardiomyopathy,
wherein the nimodipine concentrate formulation consists of:
(a) an aqueous carrier,
(b) nimodipine base or a pharmaceutically acceptable salt of nimodipine at a concentration from about 10 mg/ml to about 50 mg/ml in the aqueous carrier,
(c) an effective amount of a hydrophilic surfactant consisting of polysorbate 80,
(d) from about 0 to about 0.5% organic solvent,
(e) an optional preservative, and
(f) an optional buffering agent,
and wherein the nimodipine concentrate formulation is clear, colorless, stable, and without crystalline nimodipine precipitate.