US 12,343,330 B2
Stable pharmaceutical compositions of edaravone
Sushant Omprakash Dube, Navi Mumbai (IN); Girish G. Kore, Solapur (IN); Abhijit Balaji Pawar, Hadolti (IN); Jagdish Lotan Lohar, Pune (IN); Praveen Kumar Subbappa, Princeton, NJ (US); Sumitra Ashokkumar Pillai, Hyderabad (IN); Parvateesam Yenda, Srikakulam (IN); and Satheesh Balasubramanian, Hyderabad (IN)
Assigned to Slayback Pharma LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on Jun. 23, 2023, as Appl. No. 18/340,067.
Claims priority of application No. 202341010407 (IN), filed on Feb. 16, 2023.
Prior Publication US 2024/0285582 A1, Aug. 29, 2024
Int. Cl. A61K 31/4152 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01)
CPC A61K 31/4152 (2013.01) [A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01)] 27 Claims
OG exemplary drawing
 
1. A stable pharmaceutical composition comprising:
(i) edaravone in an amount ranging from about 10 mg/mL to about 50 mg/mL;
(ii) at least one pharmaceutically acceptable solvent selected from the group consisting of water, alcohol, glycerin, propylene glycol, polyethylene glycol, and mixtures thereof;
(iii) a crystallization inhibitor selected from the group consisting of xanthan gum, xylitol, glycerin, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, sorbitol, and mixtures thereof in an amount ranging from about 0.5% to about 50% by weight of the composition;
wherein the pharmaceutical composition is an oral solution and the composition is free of cyclodextrins;
wherein the quantity of water is up to about 50% (w/w) based on the total weight of the solution;
wherein edaravone is the only active pharmaceutical ingredient in the composition; and
wherein the composition is stable at 2-8° C. for at least 6 months.