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.
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