| 摘要 |
PROBLEM TO BE SOLVED: To provide a pharmaceutical composition for oral administration of bendamustine that is excellent in solubility.SOLUTION: Bendamustine or a pharmaceutically acceptable ester, salt, or solvate thereof and a pharmaceutically acceptable excipient are contained. The excipient is a polyethoxylated castor oil or a block copolymer of ethylene oxide and propylene oxide, or e.g., is selected from the group consisting of saccharides, such as mannitol, and a pharmaceutically acceptable saccharide, such as microcrystalline cellulose, e.g., has a mass ratio of an active ingredient to the sugar excipient of 1:1-5. The pharmaceutical composition has a pH of 1.5 in a 500 ml dissolution medium, and exhibits the dissolution of bendamustine of at least 60% after 20 minutes, 70% after 40 minutes, and 80% after 60 minutes when measuring using a paddle apparatus at 50 rpm based on European Pharmacopoeia.SELECTED DRAWING: None |
