US 12,419,867 B2
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 AZURITY PHARMACEUTICALS, INC., Woburn, MA (US)
Filed by AZURITY PHARMACEUTICALS, INC., Woburn, MA (US)
Filed on Jun. 28, 2024, as Appl. No. 18/758,225.
Application 18/758,225 is a continuation of application No. 18/502,396, filed on Nov. 6, 2023, granted, now 12,208,086.
Application 18/502,396 is a continuation of application No. 18/328,392, filed on Jun. 2, 2023, granted, now 11,844,784, issued on Dec. 19, 2023.
Application 18/328,392 is a continuation of application No. 17/877,476, filed on Jul. 29, 2022, granted, now 11,707,450, issued on Jul. 25, 2023.
Claims priority of application No. 202241011650 (IN), filed on Mar. 3, 2022.
Prior Publication US 2024/0350459 A1, Oct. 24, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4184 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01)
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)] 16 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 consisting of:
a) about 25 mg/mL of bendamustine or a pharmaceutically acceptable salt thereof;
b) at least one non-aqueous solvent consisting of ethanol, glycerine, polyethylene glycol (PEG), propylene glycol, dimethylacetamide, N-methyl-pyrrolidone, or mixtures thereof; and
c) optionally, a pH adjuster;
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 diluent prior to administration to provide a diluted liquid composition; and
wherein the liquid composition and the diluted liquid composition are antioxidant-free.