Solution formulation of cyclophosphamide
OwnerBhaveshkumar Anilkumar Patel, Mahendra R. Patelinventors
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Abstract
The present disclosure provides stable liquid formulations of cyclophosphamide. The stable liquid formulations are free from co-solvents and acidifying agents. The stable liquid formulations cyclophosphamide contains cyclophosphamide monohydrate or cyclophosphamide anhydrous, ethanol, and one or more antioxidants.
Claims15
A stable cyclophosphamide solution for parenteral administration comprising cyclophosphamide in the form of pharmaceutically acceptable hydrate and/or anhydrous forms in ethanol at about 2% w/w to 50% w/w and water at a level between 2.0% and 5.0%.
A stable cyclophosphamide solution for parenteral administration comprising cyclophosphamide in the form of pharmaceutically acceptable hydrate and/or anhydrous forms in ethanol at about 5% w/w to 50% w/w, water at a level between 2.0% and 5.0% and one or more antioxidants at a level of monothioglycerol at about 0.01% to 5% w/w and butylated hydroxytoluene at about 0.001% to 1% w/w.
Dependencies are inferred from the claim text.