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|Title:||Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents|
|Abstract:||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.|
|Inventor(s):||MAUSUSGroman; Ernest V. (Brookline, MA), Paul; Kenneth G. (Holliston, MA), Frigo; Timothy B. (Waltham, MA), Bengele; Howard (Canton, MA), Lewis; Jerome M. (Newton, MA)|
|Assignee:||AMAG Pharmaceuticals, Inc. (Lexington, MA)|
1. An 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.
2. The autoclaved unit dose of claim 1, wherein the unit dose has less than about 0.1% free iron concentration as determined by atomic absorption spectroscopy on a sample of the unit dose filtered through a 30K molecular weight cutoff micropartition membrane filter.
3. The autoclaved unit dose of claim 1, wherein the particles have a magnetic susceptibility of greater than 20,000.times.10.sup.-6 cgs.
4. A pharmacological composition comprising: an autoclaved colloid comprising particles of a superparamagnetic iron oxide coated with a carboxymethylated reduced dextran, the reduced dextran having an average molecular weight of about 10 kDa; and a biocompatible liquid, wherein the particles in the autoclaved colloid having a diameter between about 10 nm and about 50 nm.
5. The pharmacological composition of claim 4, wherein the carboxymethylated reduced dextran has at least about 1100 micromoles carboxyl per gram of the carboxymethylated reduced dextran.
6. The pharmacological composition of claim 4, having a magnetic susceptibility of greater than 20,000.times.10.sup.-6 cgs.
7. The pharmacological composition of claim 4, wherein the pharmacological composition has less than about 0.1% free iron as determined by a dialysis assay.
8. The pharmacological composition of claim 6, wherein the pharmacological composition has a free iron concentration of less than about 0.1% as determined by atomic absorption spectroscopy on a sample of the pharmacological composition filtered through a 30K molecular weight cutoff micropartition membrane filter.
9. The autoclaved unit dose of claim 1, further comprising mannitol.
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