US 12,303,506 B2
Trabectedin composition
Krishna Mohan Chilakala, Hyderabad (IN); Nagamalleswara Rao Beeraka, Hyderabad (IN); Ramesh Mantri, Sangareddy (IN); Hanumantha Rao Kamma, Baar (CH); and Janos Vaczi, Kuessnacht am Rigi (CH)
Assigned to EXTROVIS AG, Baar (CH)
Filed by EXTROVIS AG, Baar (CH)
Filed on Sep. 13, 2022, as Appl. No. 17/931,831.
Claims priority of application No. 202221003332 (IN), filed on Jan. 20, 2022.
Prior Publication US 2023/0226051 A1, Jul. 20, 2023
Int. Cl. A61K 31/4995 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/4995 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01)] 10 Claims
 
1. A stable ready-to-dilute injectable pharmaceutical composition comprising (i) a therapeutically effective amount of trabectedin of about 0.05 mg/ml and (ii) a pharmaceutically acceptable carrier consisting of one pharmaceutically acceptable solvent, one pharmaceutically acceptable pH-adjusting agent, and one pharmaceutically acceptable stabilizing agent, wherein the composition is free of ethanol, has a pH of about 2.5 to about 5, and wherein when stored for 3 months at about 2 degrees Celsius to about 8 degrees Celsius, or for 3 months at about 25 degrees Celsius, the composition has (a) not more than 3.0% of total impurities, (b) not more than 0.5% of desacetyl trabectedin impurity and (c) not more than 0.5% of dehydroxy trabectedin impurity.