US 11,707,450 B1
Stable pharmaceutical compositions of bendamustine
Harish Govindaraja Setty Chinnari, Hyderabad (IN); Somashekhar Battini, Hyderabad (IN); Sumitra Ashokkumar Pillai, Hyderabad (IN); Lourdu Chinnu Thippabattuni, Hyderabad (IN); and Satheesh Balasubramanian, Hyderabad (IN)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed on Jul. 29, 2022, as Appl. No. 17/877,476.
Claims priority of application No. 202241011650 (IN), filed on Mar. 3, 2022.
Int. Cl. A61K 31/4184 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 9/08 (2006.01)
CPC A61K 31/4184 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01)] 10 Claims
 
1. A method of treating chronic lymphocytic leukemia or indolent B cell non-Hodgkin's lymphoma comprising administering to a patient in need thereof a therapeutically effective amount of a liquid composition comprising: a) about 25 mg/mL of bendamustine or a pharmaceutically acceptable salt thereof; and b) at least one non-aqueous solvent;
wherein the at least one non-aqueous solvent is selected from the group consisting of alcohol, glycerine, polyethylene glycol (PEG), dimethylacetamide, N-methyl-pyrrolidone, dimethyl sulfoxide, and mixtures thereof;
wherein a level of total impurities in said liquid composition is not more than 5% w/w when stored at a temperature from about 2° C. to about 8° C. for 6 months as measured by HPLC;
wherein said liquid composition is diluted with a parenterally acceptable aqueous diluent prior to administration to provide a diluted liquid composition;
wherein a total volume of the diluted liquid composition is about 250 mL or less;
wherein the diluted liquid composition is administered over a period of less than or equal to about 20 minutes; and
wherein the liquid composition and the diluted liquid composition are antioxidant-free.