Polyol and Polyether Iron Oxide Complexes as Pharmacological and/or MRI Contrast Agents

摘要

Iron oxide complexes, pharmacological compositions and unit dosage thereof, and methods for their administration, of the type employing an iron oxide complex with a polyol, are disclosed. The pharmacological compositions employ a polysaccharide iron oxide complex, wherein the polysaccharide is a modified polyol such as a carboxyalkylated reduced dextran. The complex is stable to terminal sterilization by autoclaving. The compositions are suitable for parenteral administration to a subject for the treatment of iron deficiencies or as MRI contrast agent. The complex is substantially immunosilent, provide minimal anaphylaxis and undergo minimal dissolution in vivo. The pharmacological compositions of the complex contain minimal free iron which can be quantified by a variety of methods.

主权项

1. A autoclaved unit dose of an iron oxide complex comprising:
particles of a superparamagnetic iron oxide coated with a carboxymethylated reduced dextran having between about 1100 micromoles and about 1500 micromoles carboxyl per gram of carboxymethylated reduced dextran, wherein the reduced dextran has an average molecular weight of about 10 kDa, and wherein the particles have a diameter between about 10 nm and about 50 nm, and a biocompatible liquid;
wherein the autoclaved unit dose has about 500 mg to about 600 mg of iron.