Stable pharmaceutical compositions of cyclophosphamide
AssigneeSlayback Pharma LLC
InventorsShailendra MANDGE, Harish Gunda, Naga Venkata Durga Prasad Ketha, Venkateshwar Reddy Keesara, Satheesh Balasubramanian, Sumitra Ashokkumar Pillai
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Abstract
The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.
Claims13
A stable, ready-to-administer solution for oral administration comprising:
- (i) cyclophosphamide at a concentration of about 5 mg/ml to about 100 mg/ml;
- (ii) a non-aqueous lipid solvent selected from 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;
- 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.
A stable, ready-to-administer solution for oral administration comprising:
- (i) cyclophosphamide at a concentration of about 5 mg/ml to about 100 mg/ml
- (ii) a non-aqueous lipid solvent selected from 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 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.
Dependencies are inferred from the claim text.