A process for preparation of sterile cisplatin oil-in-water emulsion with reduced toxicity suitable for parenteral administration

摘要

A sterile pharmaceutical cisplatin composition as an oil-in-water emulsion having low toxicity for parenteral administration comprising:a) an oily phase selected from the group consisting of: vegetable oils, esters of medium or long chain fatty acids, and fractionated or modified oils;b) cisplatin incorporated in the oily phase;c) an emulsifier selected from the group consisting of: natural phosphatides; modified phosphatides, and synthetic non-ionic surfactants;d) a tonicity modifying agent selected from the group of compounds consisting of: glycerin, mannitol, and dextrose;e) a chelating agent selected from the group of compounds consisting of: edetates, and desferrioxamine mesylate; andf) water.