US 11,931,370 B2
Stable pharmaceutical compositions of cyclophosphamide
Shailendra Mandge, Hyderabad (IN); Harish Gunda, Nizamabad (IN); Naga Venkata Durga Prasad Ketha, Hyderabad (IN); Venkateshwar Reddy Keesara, Hyderabad (IN); Satheesh Balasubramanian, Hyderabad (IN); and Sumitra Ashokkumar Pillai, Hyderabad (IN)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on Oct. 7, 2022, as Appl. No. 17/961,943.
Prior Publication US 2023/0119069 A1, Apr. 20, 2023
Int. Cl. A01N 43/00 (2006.01); A01N 43/46 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 31/55 (2006.01); A61K 31/675 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01)
CPC A61K 31/675 (2013.01) [A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01)] 4 Claims
 
1. A stable, ready-to-administer, liquid composition for oral administration comprising:
(i) cyclophosphamide at a concentration of about 10 mg/ml;
(ii) a non-aqueous lipid solvent is selected from a group consisting of phospholipids, medium-chain fatty acids, medium-chain fatty acid esters of glycerol, medium-chain fatty acid esters of polyethylene glycol, medium-chain fatty acid esters of propylene glycol, long-chain fatty acids, long-chain fatty acid esters of glycerol, long-chain fatty acid esters of polyethylene glycol, long-chain fatty acid esters of propylene glycol, or combinations thereof; and
(iii) a co-solvent selected from ethanol and glycerin;
wherein a concentration of the non-aqueous lipid solvent ranges from about 60% to 99% by weight of the composition;
wherein a concentration of the co-solvent is less than 10% by weight of the composition; and
wherein a level of total impurities in said liquid composition is less than 5% as determined by HPLC when stored at 2-8° C. for at least 3 months.