PARENTERALLY ADMINISTERABLE OIL-IN-WATER EMULSION FOR USE AS AN X-RAY CONTRASTING AGENT WHICH IS STABLE UNDER HEAT-STERILIZATION CONDITIONS

摘要

The invention concerns a parenterally administerable oil-in-water emulsion for use as an X-ray contrasting agent which is stable to sterilization by heat, the emulsion having an inner phase consisting of one or more suitable oil-soluble iodinated fatty-acid esters, optionally together with one or more highly refined glyceride oils, plus one or more emulsifiers and optionally co-emulsifiers, and an outer phase consisting of distilled water plus isotonization additives and a physiologically tolerable buffer made up of 0 to 12 mMol/l of sodium hydroxide and 2 to 10 mMol/l of sodium carbonate and/or sodium hydrogen carbonate, in each case relative to the volume of the made-up emulsion. The mean droplet size in the inner phase of the emulsion can be adjusted to any value over the range 0.2 to 4.0 mu m, and the emulsion exhibits very good stability on storage and to heat, thus enabling it to be sterilized in an autoclave at 121 DEG C for 15 to 25 minutes.