Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
View Patent ↗Pharmacological compositions, and methods for administration, of the type employing an iron oxide complex with a polyol or polyether. The methods of administration may comprise parenteral administration of an effective dose of the complex formulated in a biocompatible liquid delivered at a rate of from about 1 mL/sec to less than 1 mL/min and wherein upon administration the complex provides minimal detectable free iron in a subject, and minimal incidence of anaphylaxis. The pharmacological compositions are of the type employing a polyol or polyether iron oxide complex, which, upon parenteral administration to a subject, are substantially immunosilent, provide minimal anaphylaxis and minimal free iron, and undergo minimal dissolution in vivo.
1. A unit dosage of a pharmacological composition comprising a terminally sterilizable autoclavable reduced carboxymethylated dextran iron oxide complex composition which is stable at 121 C and is prepared,
in a total volume of biocompatible liquid from about 1 mL to about 15 mL and for a total single dose from about 50 mg to about 600 mg, the pharmacological composition capable of being parenterally administered to a subject at a rate substantially greater than 1 mL/min and wherein the unit dosage provides upon administration:
minimal detectable free iron in the subject; and
minimal incidence of anaphylaxis.
2. A unit dosage of a pharmacological composition according to claim 1 , wherein the unit dosage provides minimal dissolution upon administration in a human subject.
3. A unit dosage of a pharmacological composition according to claim 1 , wherein the unit dosage provides minimal incidence of anaphylaxis upon administration in a human subject.
4. A unit dosage of a pharmacological composition according to claim 3 , wherein the unit dosage is substantially immunosilent upon administration in a human subject.
5. A method for administering a unit dosage of a pharmaceutical composition wherein the method comprises:
administering parenterally an effective dose of unit dosage of a pharmaceutical composition as claimed in claim 1 , the complex formulated in a biocompatible liquid so that upon administration the complex provides minimal detectable free iron in a subject, and minimal incidence of anaphylaxis; and
effecting such administration at a rate substantially greater than 1 mL/min.
6. A method for administering a unit dosage of a pharmaceutical composition according to claim 5 , further comprising effecting administration at a rate of about 1 mL/sec.
7. A method for administering a unit dosage of a pharmaceutical composition according to claim 5 , wherein the complex is formulated in a biocompatible liquid so that it provides minimal dissolution of the complex upon administration in a human subject.
8. A method for administering a unit dosage of a pharmaceutical composition according to claim 7 , wherein the complex is formulated in a biocompatible liquid so that it is substantially immunosilent upon administration in a human subject.