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Claims for Patent: 7,871,597

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Claims for Patent: 7,871,597

Title:Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Abstract: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.
Inventor(s): Groman; 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)
Application Number:10/410,527
Patent Claims: 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.
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