![]() ![]() The pharmacokinetic data was consistent with an extracellular distribution of iodixanol. Iodixanol was rapidly excreted, mainly via the kidney, with a plasma half-life in rats and monkeys of 25 and 76 min. To document the safety of iodixanol and to assess its pharmacokinetic properties, extensive tests have been performed. 1.5 Preclinical pharmacokinetics and general toxicology of iodixanol.Īcta Radiologica Supplement, 399, 69-82 (1995) Iodixanol has no apparent immediate in vitro incompatibility reactions with drugs used in connection with roentgen contrast examination. Heating to body temperature before use is acceptable and recommendable, and storage at 37 0C for 1 month does not jeopardize product quality. The stability of iodixanol is well within the specifications under all relevant conditions, both in glass and polypropylene bottles the product has a recommended shelf-life of at least 36 months when stored at room temperature and protected from light. The patented and well-proven formulation and the rationale for it are described, and the efficacy and safety documented. ![]() Iodixanol (Visipaque) is an isotonic, electrolyte-balanced roentgen contrast medium for intravascular use. In conclusion, Visipaque 320 mgI/ml does not cause any net movement of water over the human or rat erythrocyte plasma membrane, i.e., Visipaque is isotonic to human and rat blood plasma.ġ.4 Formulation, stability and compatibility of iodixanol.Īcta Radiologica Supplement, 399, 50-58 (1995) However, as with human erythrocytes, a significant decrease in water content occurred after rat blood was mixed with Omnipaque 300 mgI/ml. No difference in the water content of rat erythrocytes was evident after mixing whole blood with Visipaque 320 mgI/ml or isotonic NaCl. No change in the water content of human erythrocytes was seen after mixing whole blood 10:1 with either Visipaque 320 mgI/ml or 155 mM NaCl, whereas a significant decrease in water content occurred with Omnipque 300 mgI/ml and 620 mM NaCl. An isoosmotic solution can still cause a net movement of water over the plasma membranes of, for example, erythrocytes and endothelial cells.ĭetermination of the tonicity of Visipaque 320 mgI/ml and comparison with that of Omnipaque 300 mgI/ml and hypertonic NaCl have been performed. However, the fact that a solution is isoosmotic to plasma does not necessarily mean that it is isotonic to plasma. and Refsum, H.Īcta Radiologica Supplement, 399, 39-42 (1995)Įven at its highest concentration, 320 mgI/ml, Visipaque - based on the nonionic dimer iodixanol - is isoosmotic to blood plasma, whereas Omnipaque (300 mgI/ml) - based on the nonionic monomer iohexol - has an osmolality of about twice that of the plasma. The high hydrophilicity and the good aqueous solubility of iodixanol are due to the hydroxyl group in the dimer linkage and the hydrophilic amide side chains of the molecule.ġ.3 Visipaque is isotonic to human and rat blood plasma. Partition coefficients show that iodixanol is even more hydrophilic than the nonionic monomers such as iohexol. Iodixanol itself is an amorphous and hygroscopic solid which is freely soluble in water. The viscosity of all iodixanol (Visipaque) solutions is less than or equal to that of iohexol (Nycodenz). As a consequence of this advantageous property, solutions of all clinical concentrations of iodixanol can be made isotonic by the addition of salts of the key electrolytes sodium and calcium to the formulation. Compared to aqueous solutions of nonionic monomers, which have a higher osmolality than blood, aqueous solution of iodixanol have a lower osmolality due to the dimeric structure of the molecule. ![]() Iodixanol, the radiopaque in Visipaque, is a new nonionic, dimeric roentgen contrast medium for intravascular use. Chromatographic characteristics are related to the isomerism of iodixanol.Īcta Radiologica Supplement, 399, 32-38 (1995) The chemical structure is confirmed by spectroscopical data ( 1H-NMR, 13C-NMR, electrospray-MS, UV, IR and Raman). Two synthetic routes from 5-nitro-isophthalic acid to iodixanol are described. Visipaque is a pharmaceutical formulation of iodixanol which is isotonic and isoosmotic with blood. Iodixanol (Visipaque) is a new nonionic roentgen contrast medium intended for general use. 1 General 1.1 Synthesis and characterization of iodixanol.Īcta Radiologica Supplement, 399, 21-31 (1995) ![]()
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